### DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services 42 CFR Parts 405, 410, 411, 414, 423, and 425 [CMS-1600-FC]

RIN 0938-AR56 Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule & Other Revisions to Part B for CY 2014.

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule with comment period.

SUMMARY: This major final rule with comment peri od addresses changes to the physician fee schedule, clinical laboratory fee schedule, and other Medicare Part B payment policies to ensure that our payment systems are upda ted to reflect changes in medi cal practice and the relative

value of services. This final rule with co mment period also includes a discussion in the Supplementary Information regarding various program s. (See the Table of Contents for a listing of the specific issues addressed in the final rule with comment period.)

DATES : Effective date : The provisions of this final rule with comment period are effective on January 1, 2014, except for the amendments to §§405.350, 405.355, 405.405.2413, 405.2415, 405.2452, 410.19, 410.26, 410.37, 410.71, 410.74, 410.75, 410.76, 410.77, and 414.511, which are effective January 27, 2014, and the amendments to §§405.201, §405.203, §405.205, §405.207, §405.209, §405.211, §405.212, §405.213, §411.15, and 423.160, which are effective on January 1, 2015. The incorporation by reference of certain publica tions listed in the rule is approved by the

Director of the Federal Register as of January 1, 2014.

### CMS-1600-FC 2

Applicability dates : Additionally, the policies specified in under the following preamble sections are applicable January 27, 2014:

● Physician Compare Website (section III.G.);

● Physician Self-Referral Prohibition: Annua l Update to the List of CPT/HCPCS Codes. (section III.N.)

Comment date : To be assured considerat ion, comments must be receive d at one of the addresses provided below, no later than 5 p.m. on January 27, 2014. (See the SUPLEMENTARY

INFORMATION section of this final rule with comment period for a list of the provisions open for comment.)

ADDRESSES: In commenting, please refer to file co de CMS-1600-FC. Because of staff and resource limitations, we ca nnot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed): 1. Electronically . You may submit electronic comments on this regulation to www.regulations.gov . Follow the instructions for "submitting a comment." 2. By regular mail . You may mail written comments to the following address ONLY:

Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1600-FC, P.O. Box 8013, Baltimore, MD 21244-8013.

### CMS-1600-FC 3

Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail . You may send written comments to the following

address ONLY:

Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1600-FC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. By hand or courier . If you prefer, you may deli ver (by hand or courier) your

written comments before the close of the comment period to either of the following addresses: a. For delivery in Washington, DC--

Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201 (Because access to the interior of the Hube rt H. Humphrey Building is not readily available to persons without federal government identification, commenters are encouraged to

leave their comments in the CMS drop slots located in the main lobby of the building. A stampin clock is available for persons wishing to reta in a proof of filing by st amping in and retaining an extra copy of the comments being filed.)

### CMS-1600-FC 4

b. For delivery in Baltimore, MD--

Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850. If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members.

Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.

FOR FURTHER INFORMATION CONTACT: Elliott Isaac, (410) 786–4735 or Elliott.Isaac@cms.hhs.gov, for any physician payment

issues not identified below. Chava Sheffield, (410) 786–2298 or Chava.Shef field@cms.hhs.gov, for issues related to practice expense methodology, impacts, the sustai nable growth rate, or conversion factors. Ryan Howe, (410) 786–3355 or Ryan.Howe@cm s.hhs.gov, for issues related to direct practice expense inputs or inte rim final direct PE inputs. Kathy Kersell, (410) 786–2033 or Kathleen.K ersell@cms.hhs.gov, for issues related to

misvalued services. Jessica Bruton, (410) 786-5991 or Jessica.Br uton@cms.hhs.gov, for issues related to work or malpractice RVUs. Heidi Oumarou, (410) 786–7942 or Heidi.Ouma rou@cms.hhs.gov, for issues related to the revision of Medicare Economic Index (MEI).

### CMS-1600-FC 5

Gail Addis, (410) 786-4552 or Gail.Addis@ cms.hhs.gov, for issues related to the refinement panel. Craig Dobyski, (410) 786–4584 or Craig.Dobys ki@cms.hhs.gov, for issues related to geographic practice cost indices. Ken Marsalek, (410) 786–4502 or Kenneth.Mar salek@cms.hhs.gov, for issues related to

telehealth services. Simone Dennis, (410) 786–8409 or Simone.Den nis@cms.hhs.gov, for issues related to therapy caps. Darlene Fleischmann, (410) 786–2357 or Darlen e.Fleischmann@cms.hhs.gov, for issues related to “incident to” services or comp lex chronic care management services. Corinne Axelrod, (410) 786–5620 or Corrine.Axe lrod@cms.hhs.gov, for issues related to

“incident to” services in Rural Health Clin ics or Federally Qualified Health Centers. Roberta Epps, (410) 786–4503 or Roberta.E pps@cms.hhs.gov, for issues related to chiropractors billing for evalua tion and management services. Rosemarie Hakim, (410) 786–3934 or Rosemari e.Hakim@cms.hhs.gov, for issues related to coverage of items and services furnished in FDA-approved investigational device exemption

clinical trials. Jamie Hermansen, (410) 786–2064 or Jamie.Hermansen@cms.hhs.gov or Jyme Schafer, (410) 786–4643 or Jyme.Schafer@cms.hhs.gov, for i ssues related to ultrasound screening for abdominal aortic aneurysms or colorectal cancer screening. Anne Tayloe-Hauswald, (410) 786–4546 or Anne-E-Tayloe.Hauswald@cms.hhs.gov, for

issues related to ambulance fee sche dule and clinical lab fee schedule.

### CMS-1600-FC 6

Ronke Fabayo, (410) 786–4460 or Ronke.Fabayo@ cms.hhs.gov or Jay Blake, (410) 786– 9371 or Jay.Blake@cms.hhs.gov, for issu es related to individual liab ility for payments made to providers and suppliers and ha ndling of incorrect payments. Rashaan Byers, (410) 786–2305 or Rashaan.B yers@cms.hhs.gov, for issues related to physician compare. Christine Estella, (410) 786–0485 or Christine.Estella@cms.hhs .gov, for issues related to the physician quality reporting sy stem and EHR incentive program. Sandra Adams, (410) 786–8084 or Sandra.Adam s@cms.hhs.gov, for issues related to Medicare Shared Savings Program. Michael Wrobleswki, (410) 786–4465 or Mich ael.Wrobleswki@cms.hhs.gov, for issues

related to value-based modifier a nd improvements to physician feedback. Andrew Morgan, (410) 786–2543 or Andrew.Mor gan@cms.hhs.gov, for issues related to e-prescribing under Me dicare Part D. Pauline Lapin, (410)786–6883 or Pauline.Lapin@ cms.hhs.gov, for issues related to the chiropractic services demonstr ation budget neutrality issue.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public , including any persona lly identifiable or

confidential business information that is included in a comment. We post all comments received before the close of the comment period on the fo llowing website as soon as possible after they

have been received: http://www.regulations.gov . Follow the search inst ructions on that website to view public comments.

### CMS-1600-FC 7

Comments received timely will also be av ailable for public inspection as they are received, generally beginning approximately 3 w eeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view pub lic comments, phone 1-800-743-3951.

Table of Contents I. Executive Summary and Background A. Executive Summary B. Background

II. Provisions of the Final Rule with Comment Period for PFS A. Resource-Based Practice Expense (PE) Relative Value Units (RVUs)

B. Misvalued Services C. Malpractice RVUs D. Medicare Economic Index (MEI) E. Establishing RVUs for CY 2014 F. Geographic Practice Cost Indices (GPCIs) G. Allowed Expenditures for Physicians' Se rvices and the Sustainable Growth Rate

H. Medicare Telehealth Services for the Physician Fee Schedule I. Therapy Caps J. Requirements for Billing “Incident To” Services K. Chronic Care Management (CCM) Services L. Collecting Data on Services Furnished in Off-Campus Provider-Based Departments M. Chiropractors Billing for Ev aluation & Management Services

### CMS-1600-FC 8

III. Other Provisions of the Proposed Regulations A. Medicare Coverage of Items and Servi ces in FDA-Approved Investigational Device Exemption Clinical Studies--Revisions of Medicare Coverage Requirements B. Ultrasound Screening for Abdominal Aortic Aneurysms C. Colorectal Cancer Screening: Modificat ion to Coverage of Screening Fecal Occult

Blood Tests

D. Ambulance Fee Schedule E. Policies Regarding the C linical Laboratory Fee Schedule F. Liability for Overpayments to or on Be half of Individuals in cluding Payments to

Providers or Other Persons G. Physician Compare Website H. Physician Payment, Efficiency, and Quality Improvements – Physician Quality Reporting System

I. Electronic Health Reco rd (EHR) Incentive Program J. Medicare Shared Savings Program K. Value-Based Payment Modifier and Physician Feedback Program L. Updating Existing Standards for E-Prescribing under Medicare Part D M. Discussion of Budget Neutrality for the Chiropractic Services Demonstration N. Physician Self-Referral Prohibition: Annual Update to the List of CPT/HCPCS

Codes IV. Collection of Information Requirements V. Response to Comments VI. Waiver of Proposed Rulemaking a nd Waiver of Delay of Effective Date

### CMS-1600-FC 9

VII. Regulatory Impact Analysis Regulations Text Acronyms In addition, because of the many organizati ons and terms to which we refer by acronym in this final rule with comment period, we are listing these acronyms and their corresponding terms in alphabetical order below: AAA Abdominal aortic aneurysms ACA Affordable Care Act (Pub. L. 111–148) ACO Accountable care organization AHE Average hourly earnings

AMA American Medical Association AMA RUC AMA [Specialty Society] Relative (Value) Update Committee ASC Ambulatory surgical center ATRA American Taxpayer Relief Act (Pub. L. 112-240)

AWV Annual wellness visit BBA Balanced Budget Act of 1997 (Pub. L. 105-33) BBRA [Medicare, Medicaid and State Child H ealth Insurance Program] Balanced Budget Refinement Act of 1999 (Pub. L. 106-113) BEA Bureau of Economic Analysis CAH Critical access hospital

CBSA Core-Based Statistical Area CCM Chronic Care Management CED Coverage with evidence development

### CMS-1600-FC 10

CEHRT Certified EHR technology

CF Conversion factor CLFS Clinical Laboratory Fee Schedule

CMD Contractor medical director CMHC Community mental health center CMT Chiropractic manipulative treatment CORF Comprehensive outpatient rehabilitation facility CPC Comprehensive Primary Care CPEP Clinical Practice Expert Panel

CPI-U Consumer Price Index for Urban Areas CPS Current Population Survey CPT [Physicians] Current Procedural Terminology ( CPT codes, descriptions and other data only are copyright 2013 American Medica l Association. All rights reserved. ) CQM Clinical quality measure CT Computed tomography CTA Computed tomographic angiography CY Calendar year DFAR Defense Federal Acquisition Regulations DHS Designated health services DRA Deficit Reduction Act of 2005 (Pub. L.109–171) DSMT Diabetes self-management training ECEC Employer Costs for Employee Compensation ECI Employment Cost Index

### CMS-1600-FC 11

eCQM Electronic clinical quality measures

EHR Electronic health record EMTALA Emergency Medical Treatment and Labor Act eRx Electronic prescribing ESRD End-stage renal disease FAR Federal Acquisition Regulations

FFS Fee-for-service

FOBT Fecal occult blood test FQHC Federally qualified health center

FR Federal Register GAF Geographic adjustment factor

GAO Government Accountability Office GPCI Geographic practice cost index GPRO Group practice reporting option

HCPCS Healthcare Common Procedure Coding System HHS [Department of] Health and Human Services HOPD Hospital outpatient department HPSA Health professional shortage area IDE Investigational device exemption IDTF Independent diagnostic testing facility

IOM Institute of Medicine IPPE Initial Preventive Physical Examination IPPS Inpatient Prospective Payment System

### CMS-1600-FC 12

IQR Inpatient Quality Reporting IWPUT Intensity of wo rk per unit of time KDE Kidney disease education LCD Local coverage determination LDT Laboratory-developed test MA Medicare Advantage

MAC Medicare Administrative Contractor MAPCP Multi-payer Advanced Primary Care Practice

MCTRJCA Middle Class Tax Relief and J ob Creation Act of 2012 (Pub. L. 112-96) MDC Major diagnostic category MedPAC Medicare Payment Advisory Commission

MEI Medicare Economic Index MFP Multi-Factor Productivity MGMA Medical Group Management Association MIEA-TRHCA The Medicare Improvements a nd Extension Act, Division B of the Tax Relief and Health Care Act (Pub. L. 109-432) MIPPA Medicare Improvements for Patient s and Providers Act (Pub. L. 110-275)

MMEA Medicare and Medicaid Extenders Act (Pub. L. 111-309) MMSEA Medicare, Medicaid, and State Childr en’s Health Insurance Program Extension Act (Pub. L. 110-73) MP Malpractice MPPR Multiple procedure payment reduction MRA Magnetic resonance angiography

### CMS-1600-FC 13

MRI Magnetic resonance imaging MSA Metropolitan Statistical Areas MSPB Medicare Spe nding per Beneficiary MSSP Medicare Shared Savings Program MU Meaningful use NCD National coverage determination NCQDIS National Coalition of Qual ity Diagnostic Imaging Services NP Nurse practitioner

NPI National Provider Identifier NPP Nonphysician practitioner OACT CMS's Office of the Actuary OBRA ‘89 Omnibus Budget Reconciliation Act of 1989 OBRA ’90 Omnibus Budget Reconciliation Act of 1990 OES Occupational Employment Statistics OMB Office of Management and Budget OPPS Outpatient prospective payment system PC Professional component PCIP Primary Care Incentive Payment PDP Prescription Drug Plan PE Practice expense PE/HR Practice expense per hour PEAC Practice Expense Advisory Committee PECOS Provider Enrollment, Chain, and Ownership System

### CMS-1600-FC 14

PFS Physician Fee Schedule PLI Professional Liability Insurance PMA Premarket approval

POS Place of Service PQRS Physician Quality Reporting System PPIS Physician Practice Expense Information Survey QRUR Quality and Resources Use Report

RBRVS Resource-based re lative value scale RFA Regulatory Flexibility Act

RHC Rural health clinic RIA Regulatory impact analysis RoPR Registry of Patient Registries RUCA Rural Urban Commuting Area

RVU Relative value unit

SBA Small Business Administration SGR Sustainable growth rate SMS Socioeconomic Monitoring System SNF Skilled nursing facility

SOI Statistics of Income TAP Technical Advisory Panel TC Technical component

TIN Tax identification number TPTCCA Temporary Payroll Tax Cu t Continuation Act (Pub. L. 112-78)

### CMS-1600-FC 15

UAF Update adjustment factor

USPSTF United States Preventive Services Task Force VBP Value-based purchasing

VBM Value-Based Modifier Addenda Available Only Through th e Internet on the CMS Website The PFS Addenda along with other supporting docu ments and tables referenced in this final rule with comment period are availabl e through the Internet on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-fo r-Service-Payment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html . Click on the link on the left si de of the screen titled, ‘‘PFS Federal Regulations Notices’’ for a chronological list of PFS Federal Register and other related documents. For the CY 2014 PFS final rule with comment period, refer to item CMS–1600–FC. Readers who experience any problems accessing any of the Addenda or other documents

referenced in this final rule with comment period and posted on the CMS website identified above should contact Elliot.Isaac@cms.hhs.gov. CPT (Current Procedural Terminology) Copyright Notice Throughout this final rule with comment pe riod, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descrip tions are copyright 2013

American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association (AMA). Applic able Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply. I. Executive Summary and Background A. Executive Summary 1. Purpose

### CMS-1600-FC 16

This major final rule with comment peri od revises payment polices under the Medicare Physician Fee Schedule (PFS) and makes other policy changes related to Medicare Part B payment. Unless otherwise noted, these changes are applicable to services furnished in CY

2014. 2. Summary of the Major Provisions The Social Security Act (Act) requires us to establish payments under the PFS based on national uniform relative value units (RVUs) that account for the relative resources used in furnishing a service. The Act requires that RVUs be established for three categories of resources: work, practice expens e (PE); and malpractice (MP) expe nse; and that we establish by regulation each year payment amounts for all physicians’ services, in corporating geographic adjustments to reflect the variations in the cost s of furnishing services in different geographic areas. In this major final rule with comment period, we establish RVUs for CY 2014 for the PFS, and other Medicare Part B payment policies, to ensure that our payment systems are updated to reflect changes in medical practice an d the relative value of services as well as changes in the statute. In a ddition, this final rule with co mment period includes discussions and/or policy changes regarding:

● Misvalued PFS Codes.

● Telehealth Services.

● Applying Therapy Caps to Outpatie nt Therapy Services Furnished by CAHs.

● Requiring Compliance with State law as a Condition of Payment for Services Furnished Incident to Physicians’ (and Other Practitioners’) Services.

● Revising the MEI based on MEI TAP Recommendations.

● Updating the Ambulance Fee Schedule regulations.

### CMS-1600-FC 17

● Adjusting the Clinical Laboratory F ee Schedule based on technological changes

● Updating the- ++ Physician Compare Website. ++ Physician Quality Reporting System. ++ Electronic Prescribing (eRx) Incentive Program. ++ Medicare Shared Savings Program.

++ Electronic Health Record (EHR) Incentive Program.

● Budget Neutrality for the Chir opractic Services Demonstration.

● Physician Value-Based Payment Modifier and the Physician Feedback Reporting Program. 3. Summary of Costs and Benefits

We have determined that this final rule w ith comment period is economically significant. For a detailed discussion of the economic impacts, see section VII. of this final rule with comment period. B. Background Since January 1, 1992, Medicare has paid for physicians’ services under section 1848 of the Act, “Payment for Physicians' Services.” Th e system relies on national relative values that are established for work, PE, and MP, which are th en adjusted for geographic cost variations. These values are multiplied by a conversion factor (C F) to convert the RVUs into payment rates. The concepts and methodology underlying the PFS we re enacted as part of the Omnibus Budget Reconciliation Act of 1989 (OBRA ’89) (P ub. L. 101-239, enacted on December 19, 1989), and the Omnibus Budget Reconciliation Act of 1990 ( OBRA ’90 (Pub. L. 101-508, enacted on

### CMS-1600-FC 18

November 5, 1990). The final rule published on November 25, 1991 (56 FR 59502) set forth the first fee schedule used for paym ent for physicians’ services. We note that throughout this final rule w ith comment period, unless otherwise noted, the term “practitioner” is used to describe both physicians and nonphysician practitioners who are permitted to bill Medicare under the PFS for servi ces furnished to Medicare beneficiaries. 1. Development of the Relative Values

a. Work RVUs The physician work RVUs established for th e implementation of the fee schedule in January 1992 were developed with extensive in put from the physician community. A research

team at the Harvard School of Public Health developed the original physician work RVUs for most codes under a cooperative ag reement with the Department of Health and Human Services (HHS). In constructing the code-specific vignett es used in determining the original physician work RVUs, Harvard worked with panels of experts, both inside and outside the federal government, and obtained input from nume rous physician specialty groups.

We establish work RVUs fo r new and revised codes based, in part, on our review of

recommendations received from the American Medical Association/Specialty Society Relative Value Update Committee (AMA RUC). b. Practice Expense RVUs Initially, only the work RVUs were resour ce-based, and the PE and MP RVUs were based on average allowable charges. Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 103-432, enacted on October 31, 1994), amended section 1848(c)(2)(C)(ii) of the Act and required us to develop resource- based PE RVUs for each physicians’ service beginning in 1998. We were required to consider general categories of expenses (such as office

### CMS-1600-FC 19

rent and wages of personnel, but excluding malp ractice expenses) comprising PEs. Originally, this method was to be used beginning in 1998, but section 4505(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33, enacted on August 5, 1997) delayed implementation of the resource-based PE RVU system until January 1, 1999. In addition, section 4505(b) of the BBA provided for a 4-year transition period from the ch arge-based PE RVUs to the resource-based PE

RVUs.

We established the resource-based PE RVUs for each physicians’ service in a final rule, published November 2, 1998 (63 FR 58814), effective for services furnished in CY 1999. Based on the requirement to transition to a resource-bas ed system for PE over a 4-year period, payment rates were not fully based upon resource-based PE RVUs until CY 2002. This resource-based system was based on two significant sources of actu al PE data: the Clinical Practice Expert Panel (CPEP) data and the AMA’s Socioeconomic Monitoring System (SMS) data. (These data sources are described in greater detail in the CY 2012 final rule with comment period (76 FR 73033).) Separate PE RVUs are established for services furnished in facility settings, such as a hospital outpatient department (HOPD) or an ambulatory surgical center (ASC), and in nonfacility settings, such as a physic ian’s office. The nonfacility RVUs reflect all of the direct and

indirect PEs involved in furn ishing a service described by a particular HCPCS code. The difference, if any, in these PE RVUs generally results in a higher payment in the nonfacility setting because in the facility settings some cost s are borne by the facility. Medicare’s payment to the facility (such as the out patient prospective payment system (OPPS) payment to the HOPD) would reflect costs typically incu rred by the facility. Thus, payment associated with those facility

resources is not made under the PFS.

### CMS-1600-FC 20

Section 212 of the Balanced Budget Refi nement Act of 1999 (BBRA) (Pub. L. 106-113, enacted on November 29, 1999) directed the Secr etary of Health and Human Services (the Secretary) to establish a process under whic h we accept and use, to the maximum extent practicable and consistent with sound data practices, data collected or developed by entities and organizations to supplement the data we normally collect in determining the PE component. On May 3, 2000, we published the interim final rule ( 65 FR 25664) that set fort h the criteria for the submission of these supplemental PE survey data . The criteria were modified in response to comments received, and published in the Federal Register (65 FR 65376) as part of a November 1, 2000 final rule. The PFS fina l rules published in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended the period during which we would accept these supplemental data through March 1, 2005.

In the CY 2007 PFS final rule with comme nt period (71 FR 69624) , we revised the methodology for calculating direct PE RVUs fr om the top-down to the bottom-up methodology beginning in CY 2007. We adopted a 4-year trans ition to the new PE RVUs. This transition was completed for CY 2010. In the CY 2010 PFS final rule with comment pe riod, we updated the practice expense per hour (PE/HR) da ta that are used in the calc ulation of PE RVUs for most specialties (74 FR 61749). In CY 2010, we began a 4-year transition to the new PE RVUs using the updated PE/HR data, which was completed for CY 2013. c. Malpractice RVUs Section 4505(f) of the BBA amended section 1848(c) of the Act to require that we implement resource-based MP RVUs for se rvices furnished on or after CY 2000. The resource-based MP RVUs were implemented in the PFS final rule with comment period published November 2, 1999 (64 FR 59380). The MP RVUs are based on malpractice insurance

### CMS-1600-FC 21

premium data collected from commercial and phys ician-owned insurers from all the states, the District of Columbia, and Puerto Rico.

d. Refinements to the RVUs Section 1848(c)(2)(B)(i) of th e Act requires that we revi ew RVUs no less often than every 5 years. Prior to CY 2013, we conducted pe riodic reviews of work RVUs and PE RVUs independently. We completed Five-Year Reviews of Work RVUs that were effective for calendar years 1997, 2002, 2007, and 2012. While refinements to the direct PE inputs in itially relied heavily on input from the AMA RUC Practice Expense Advisory Committee (P EAC), the shifts to the bottom-up PE methodology in CY 2007 and to the use of the updated PE/HR data in CY 2010 have resulted in significant refinements to the PE RVUs in recent years.

In the CY 2012 PFS final rule with comme nt period (76 FR 73057), we finalized a proposal to consolidate reviews of work and PE RVUs under se ction 1848(c)(2)(B ) of the Act and reviews of potentially misv alued codes under section 1848(c )(2)(K) of the Act into one annual process. With regard to MP RVUs, we completed Five-Year Reviews of MP that were effective in

CY 2005 and CY 2010. In addition to the Five-Year Reviews, beginning for CY 2009, CMS and the AMA RUC have identified and reviewed a number of poten tially misvalued codes on an annual basis based

on various identification screens. This annual review of work and PE RVUs for potentially misvalued codes was supplemented by the amendmen ts to section 1848 of the Act, as enacted by section 3134 of the Affordable Care Act, whic h requires the agency to periodically identify,

### CMS-1600-FC 22

review and adjust values for potentially misv alued codes with an emphasis on seven specific categories (see section II.C.2. of this final rule with comment period). e. Application of Budget Neutra lity to Adjustments of RVUs

As described in section VII. C.1. of this final rule with comment period, in accordance with section 1848(c)(2 )(B)(ii)(II) of the Act, if revisions to the RVUs would cause expenditures for the year to change by more than $20 million, we make adjustments to ensure that expenditures do not increase or decrease by more than $20 million. 2. Calculation of Payments Based on RVUs To calculate the payment for each physicia ns’ service, the components of the fee schedule (work, PE, and MP RVUs) are adjusted by geographic practice cost indices (GPCIs) to

reflect the variations in the cost s of furnishing the services. Th e GPCIs reflect the relative costs of physician work, PE, and MP in an area comp ared to the national average costs for each component. (See section II.F.2 of this final ru le with comment period for more information about GPCIs.)

RVUs are converted to dollar amounts th rough the application of a CF, which is calculated based on a statutory formula by CMS's Office of the Actuary (OACT). The CF for a given year is calculated using (a) the productivity-adj usted increase in th e Medicare Economic Index (MEI) and (b) the Update Adjustment Fact or (UAF), which is calculated by taking into

account the Medicare Sustainable Gr owth Rate (SGR), an annual grow th rate intended to control growth in aggregate Medicare expenditures for physicians’ services, and the allowed and actual expenditures for physicians’ services. For a more de tailed discussion of th e calculation of the CF, the SGR, and the MEI, we refer readers to section II.G. of this final rule with comment period.

### CMS-1600-FC 23

The formula for calculating the Medicare fee schedule payment amount for a given

service and fee schedule area can be expressed as: Payment = [(RVU work x GPCI work) + (R VU PE x GPCI PE) + (RVU MP x GPCI MP)] x CF. 3. Separate Fee Schedule Methodo logy for Anesthesia Services Section 1848(b)(2)(B) of the Ac t specifies that the fee sche dule amounts for anesthesia

services are to be based on a uniform relative value guide, with appropri ate adjustment of an anesthesia conversion factor, in a manner to as sure that fee schedule amounts for anesthesia

services are consistent with thos e for other services of comparable value. Therefore, there is a separate fee schedule methodology for anesthesia se rvices. Specifically, we establish a separate

conversion factor for anesthesia services and we u tilize the uniform relative value guide, or base units, as well as time units, to calculate the f ee schedule amounts for anesthesia services. Since anesthesia services are not valued using RVUs , a separate methodology for locality adjustments is also necessary. This involves an adjustment to the national anesthesia CF for each payment locality. 4. Most Recent Changes to the Fee Schedule The CY 2013 PFS final rule with comment period (77 FR 68892) implemented changes to the PFS and other Medicare Part B payment polic ies. It also finalized many of the CY 2012

interim final RVUs and establis hed interim final RVUs for ne w and revised codes for CY 2013 to ensure that our payment system is updated to reflect changes in medical practice, coding changes, and the relative values of services. It also implemented cert ain statutory provisions including provisions of the Affordable Care Act (Pub. L. 111–148) and the Middle Class Tax

### CMS-1600-FC 24

Relief and Jobs Creation Act (MCTRJCA) (P ub. L. 112-96), including claims-based data reporting requirements for therapy services. In the CY 2013 PFS final rule with comment period, we announced the following for CY 2013: the total PFS update of -26.5 percent; the initial estimate for th e SGR of -19.7 percent; and the CY 2013 CF of $25.0008. These figures were calculated based on the statutory provisions in effect on November 1, 2012, when the CY 2013 PFS final rule with comment period was issued. On January 2, 2013, the American Taxpayer Relief Act (ATRA) of 2012 (Pub. L. 112- 240) was signed into law. Section 601(a) of th e ATRA specified a zero percent update to the PFS CF for CY 2013. As a result, the CY 2013 PFS conversion factor was revised to $34.0320. In addition, the ATRA extended and added severa l provisions affecti ng Medicare services furnished in CY 2013, including:

● Section 602 – extending the 1.0 floor on th e work geographic practice cost index through CY 2013;

● Section 603 – extending the exceptions pro cess for outpatient therapy caps through CY 2013, extending the application of the cap and ma nual medical review threshold to services furnished in the HOPD through CY 2013, and re quiring the counting of a proxy amount for therapy services furnished in a Critical Access Hospital (CAH) toward the cap and threshold during CY 2013. In addition to the changes effective fo r CY 2013, section 635 of ATRA revised the equipment utilization rate assumption for adva nced imaging services furnished on or after January 1, 2014.

### CMS-1600-FC 25

A correction document (78 FR 48996) was i ssued to correct se veral technical and typographical errors that occurred in the CY 2013 PFS final rule with comment period.

### CMS-1600-FC 26

II. Provisions of the Final Rule with Comment Period for PFS A. Resource-Based Practice Expense (PE) Relative Value Units (RVUs)

1. Overview Practice expense (PE) is the portion of th e resources used in furnishing a service that reflects the general cate gories of physician and practiti oner expenses, such as office rent and personnel wages, but excluding malp ractice expenses, as specified in section 1848(c)(1)(B) of the Act. Section 121 of the Social Security Amendments of 1994 (Pub. L. 103-432), enacted on October 31, 1994, amended section 1848(c)(2)(C)(ii) of the Act to require us to develop a me thodology for a resource-based system for determining PE RVUs for each physician’s serv ice. We develop PE RVUs by looking at the direct and indirect practi ce resources involved in furnis hing each service. Direct expense categories include clin ical labor, medical supplies, and medical equipment. Indirect expenses include administrative labor , office expense, and all other expenses. The sections that follow provide more de tailed information about the methodology for translating the resources involved in furnis hing each service into service-specific PE

RVUs. We refer readers to the CY 2010 PFS final rule with comment period (74 FR 61743 through 61748) for a more detail ed explanation of the PE methodology. In addition, we note that section 1848(c )(2)(B)(ii)(II) of the Act provides that adjustments in RVUs for a year may not cause total PFS payments to differ by more than $20 million from what they would have otherwis e been if the adjustments were not made. Therefore, if revisions to the RVUs cau se expenditures to change by more than $20 million, we make adjustments to ensure th at expenditures do not increase or decrease by more than $20 million.

### CMS-1600-FC 27

2. Practice Expense Methodology a. Direct Practice Expense We determine the direct PE for a specifi c service by adding the costs of the direct resources (that is, the clinical st aff, equipment, and supplies) t ypically involved with furnishing

that service. The costs of the resources are cal culated using the refined direct PE inputs assigned to each CPT code in our PE database, whic h are based on our review of recommendations

received from the AMA RUC and those provided in response to public comment periods. For a detailed explanation of the direct PE methodolog y, including examples, we refer readers to the

Five-Year Review of Work Relative Value Un its Under the PFS and Proposed Changes to the Practice Expense Methodology proposed notice ( 71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629).

b. Indirect Practice Ex pense per Hour Data We use survey data on indirect PEs incurre d per hour worked in developing the indirect portion of the PE RVUs. Prior to CY 2010, we primarily used the practice expense per hour (PE/HR) by specialty that was obtained from the AMA’s Socioeconomic Monitoring Surveys (SMS). The AMA administered a new survey in CY 2007 and CY 2008, the Physician Practice Expense Information Survey (PPIS). The PPIS is a multispecialty, nationally representative, PE survey of both physicians and nonphysician prac titioners (NPPs) paid under the PFS using a survey instrument and methods highly consis tent with those used for the SMS and the supplemental surveys. The PPIS gathered information from 3,656 respondents across 51 physician specialty and health care professional groups. We believe the PPIS is the most comprehensive source of PE survey information av ailable. We used the PPIS data to update the

PE/HR data for the CY 2010 PFS for almost all of the Medicare-recognized specialties that

### CMS-1600-FC 28

participated in the survey. When we began using the PPIS data in CY 2010, we did not change the PE RVU methodology itself or the manner in which the PE /HR data are used in that methodology. We only updated the PE/HR data based on the new surv ey. Furthermore, as we explained in the CY 2010 PFS final rule with comment period (74 FR 61751), because of the magnitude of payment reductions for some specialties resulting from the use of the PPIS data, we transitioned its use over a 4-year period (75 percent old/25 percent new for CY 2010, 50 percent old/50 percent new for CY 2011, 25 percent old/ 75 percent new for CY 2012, and 100 percent new for CY 2013) from the previous PE RVUs to the PE RVUs developed using the new PPIS data. As provided in the CY 2010 PFS fina l rule with comment period (74 FR 61751), the transition to the PPIS data was complete for CY 2013. Therefore, the CY 2013 and CY 2014 PE RVUs are developed based entirely on the PPIS da ta, except as noted in this section. Section 1848(c)(2)(H)(i) of the Act re quires us to use the medical oncology supplemental survey data submitted in 2003 fo r oncology drug administration services. Therefore, the PE/HR for medical oncology, he matology, and hematology/oncology reflects the continued use of these supplemental survey data. Supplemental survey data on independent labs from the College of American Pathologists were implemented for payments be ginning in CY 2005. Supplemental survey data from the National Coalition of Quality Diagnos tic Imaging Services (NCQDIS), representing independent diagnostic testing fac ilities (IDTFs), were blended with supplementary survey data from the American College of Radiology (ACR) and implemented for payments beginning in CY 2007. Neither IDTFs, nor independent labs, participated in the PPIS. Therefore, we continue to use the PE/HR that was develope d from their supplemental survey data.

### CMS-1600-FC 29

Consistent with our past pr actice, the previous indire ct PE/HR values from the supplemental surveys for these specialties were updated to CY 2006 using the MEI to put them on a comparable basis with the PPIS data. We also do not use the PPIS data for repr oductive endocrinology and spine surgery since these specialties currently are not separately recognized by Medicare, nor do we have a method

to blend the PPIS data with Medica re-recognized speci alty data. We do not use the PPIS data for sleep medicine since there is not a fu ll year of Medicare utilization data for that specialty given the specialty code was only available beginning in October 1, 2012. We anticipate using the PPIS data to create PE/HR for sleep medicine for CY 2015 when we will have a full year of data to make the calculations. Previously, we established PE/HR values for various specialties without SMS or supplemental survey data by crosswalking them to other similar specialties to estimate a proxy PE/HR. For specialties that were part of the PPIS for which we previously used a crosswalked PE/HR, we instead used the PPIS-based PE/HR. We continue previous crosswalks for specialties that did not particip ate in the PPIS. However, be ginning in CY 2010 we changed the PE/HR crosswalk for portable x-ray suppliers from radiology to IDTF, a more appropriate crosswalk because these specialties are more simila r to each other with respect to physician time. For registered dietician services, the resour ce-based PE RVUs have been calculated in accordance with the final policy th at crosswalks the specialty to the “All Physicians” PE/HR data, as adopted in the CY 2010 PFS final rule with comment period (74 FR 61752) and

discussed in more detail in th e CY 2011 PFS final rule with comment period (75 FR 73183).

c. Allocation of PE to Services To establish PE RVUs for specific services , it is necessary to establish the direct

### CMS-1600-FC 30

and indirect PE associated with each service. (1) Direct Costs The relative relationship between the direct cost portions of the PE RVUs for any two services is determined by the relative rela tionship between the sum of the direct cost resources (that is, the clinical staff, equipment, and supplie s) typically involved with furnishing each of the services . The costs of these resour ces are calculated from the refined direct PE inputs in our PE database. For example, if one service has a direct cost sum of $400 from our PE database and anothe r service has a direct cost sum of $200, the direct portion of the PE RVUs of the first se rvice would be twice as much as the direct portion of the PE RVUs fo r the second service. (2) Indirect Costs

Section II.B.2.b. of this final rule with comment period describes the current data sources for specialty-specific indirect costs us ed in our PE calculations. We allocated the

indirect costs to the c ode level on the basis of the direct costs specifically associated with a code and the greater of either the clinical labor costs or the phys ician work RVUs. We also incorporated the survey data describe d earlier in the PE/HR di scussion. The general approach to developing the indi rect portion of the PE RVUs is described as follows:

• For a given service, we use the dir ect portion of the PE RVUs calculated as previously described and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that furnish the service to determine an

initial indirect allocator. In other words, the initial indirect allocator is calculated so that the direct costs equal the average percentage of direct costs of those specialties furnishing the service. For example, if the direct portion of the PE R VUs for a given service is 2.00

### CMS-1600-FC 31

and direct costs, on average, represented 25 pe rcent of total costs for the specialties that furnished the service, the initial indirect allo cator would be calculated so that it equals 75 percent of the total PE RVUs. Thus, in this example the initial i ndirect allocator would equal 6.00, resulting in a total PE RVUs of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00).

• Next, we add the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initial indirect allocator. In our example, if this

service had work RVUs of 4.00 and the clinical labor portion of the direct PE RVUs was 1.50, we would add 4.00 (since the 4.00 work RV Us are greater than the 1.50 clinical labor portion) to the initial indi rect allocator of 6 .00 to get an indirect allocator of 10.00. In the absence of any further use of the surv ey data, the relative relationship between the indirect cost portions of the PE RVUs for any two services would be determined by the relative relationship between thes e indirect cost allocators. For example, if one service

had an indirect cost allocator of 10.00 and another service ha d an indirect cost allocator of 5.00, the indirect portion of the PE RVUs of the first service would be twice as great as the indirect portion of the PE R VUs for the second service.

• Next, we incorporate the specialty-s pecific indirect PE/HR data into the calculation. In our example, if based on the su rvey data, the average indirect cost of the specialties furnishing the first service with an allocator of 10.00 was half of the average indirect cost of the specialties furnishing the second service w ith an indirect allocator of 5.00, the indirect portion of the PE RVUs of the first service would be equal to that of the

second service. d. Facility and Nonfacility Costs

### CMS-1600-FC 32

For procedures that can be furnished in a physician’s office, as well as in a hospital or facility setting, we establish two PE RVUs: facility and nonfacility. The methodology for calculating PE RVUs is the sa me for both the facility and nonfacility RVUs, but is applied independently to yi eld two separate PE RVUs. Because in calculating the PE RVUs for services furnishe d in a facility, we do not include resources that would generally not be provided by physicians when furnishing the service in a facility, the facility PE RVUs are genera lly lower than the nonfacility PE RVUs. Medicare makes a separate payment to the faci lity for its costs of furnishing a service. e. Services with Technical Components (TCs) and Professional Components (PCs) Diagnostic services are generally compri sed of two components: a professional component (PC); and a technical component (TC). The PC and TC may be furnished independently or by different pr oviders, or they may be furnis hed together as a “global” service. When services have separately bi llable PC and TC components, the payment for the global service equals the su m of the payment for the TC and PC. To achieve this we use a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global service, TCs, and PCs; th at is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global service, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global under the bottom-up methodology.) f. PE RVU Methodology For a more detailed description of th e PE RVU methodology, we refer readers to the CY 2010 PFS final rule with comment period (74 FR 61745 through 61746). (1) Setup File

### CMS-1600-FC 33

First, we create a setup file for the PE methodology. The setu p file contains the direct cost inputs, the utilization for each procedure code at the specialty and facility/nonfacility place of service level, and the specialty-specific PE/HR data calculated from the surveys. (2) Calculate the Direct Cost PE RVUs Sum the costs of each direct input. Step 1 : Sum the direct costs of the inputs for each service. Apply a scaling adjustment to the direct inputs. Step 2 : Calculate the aggregate pool of direct PE costs for the current year. This is the product of the current aggregate PE (direct and indirect) RVUs, the CF, and the average direct PE percentage from the surv ey data used for calculating the PE/HR by specialty. Step 3 : Calculate the aggregate pool of direct PE costs for use in ratesetting. This is the product of the aggregated direct costs for all services from Step 1 and the utilization data for that service. For CY 2014, we adjust ed the aggregate pool of direct PE costs in proportion to the change in the PE share in th e revised MEI, as discussed in section II.D.

of this final rule with comment period. Step 4: Using the results of Step 2 and St ep 3, calculate a direct PE scaling adjustment to ensure that the aggregate pool of direct PE costs calcu lated in Step 3 does not vary from the aggregate pool of direct PE costs for the current year. Apply the scaling factor to the direct costs for eac h service (as calculated in Step 1). Step 5 : Convert the results of Step 4 to an RVU scale for each service. To do this, divide the results of Step 4 by the CF. No te that the actual value of the CF used in

### CMS-1600-FC 34

this calculation does not influence the final di rect cost PE RVUs, as long as the same CF is used in Step 2 and Step 5. Different CFs will result in different direct PE scaling factors, but this has no effect on the final di rect cost PE RVUs since changes in the CFs and changes in the associated direct s caling factors offset one another. (3) Create the Indirect Cost PE RVUs

Create indirect allocators. Step 6 : Based on the survey data, calculate di rect and indirect PE percentages for each physician specialty. Step 7 : Calculate direct and indirect PE pe rcentages at the service level by taking a weighted average of the results of Step 6 fo r the specialties that furnish the service. Note that for services with TCs and PCs, th e direct and indirect percentages for a given service do not vary by the PC, TC, and global service. Step 8 : Calculate the service level alloca tors for the indirect PEs based on the percentages calculated in Step 7. The indirect PEs are allocated based on the three components: the direct PE RVUs; the c linical PE RVUs; and the work RVUs.

For most services the indirect allocator is : indirect PE per centage * (direct PE RVUs/direct percentage) + work RVUs.

There are two situations wher e this formula is modified:

• If the service is a global service (that is, a service with global, professional, and technical components), then the indirect PE allocator is: indirect percentage (direct PE RVUs/direct percentage) + c linical PE RVUs + work RVUs.

• If the clinical labor PE RVUs exceed the work RVUs (and the service is not a global service), then the indi rect allocator is: indire ct PE percentage (direct

### CMS-1600-FC 35

PE RVUs/direct percentage) + clinical PE RVUs. (Note : For global services, the indirect PE a llocator is based on both the work RVUs and

the clinical labor PE RVUs. We do this to r ecognize that, for the PC service, indirect PEs will be allocated using the work RVUs, and for the TC service, indirect PEs will be allocated using the direct PE RVUs and the clin ical labor PE RVUs. This also allows the global component RVUs to equal the sum of the PC and TC RVUs.) For presentation purposes in the examples in Table 1, th e formulas were divided into two parts for each service.

• The first part does not vary by service a nd is the indirect pe rcentage (direct PE RVUs/direct percentage).

• The second part is either the work RVU, clinical labor PE RVU, or both depending on whether the service is a global service and whether the clinical PE RVUs exceed the work RVUs (as describe d earlier in this step). Apply a scaling adjustment to the indirect allocators. Step 9 : Calculate the current aggregate pool of indirect PE RVUs by multiplying the current aggregate pool of PE RVUs by the average indire ct PE percentage from the survey data. Step 10 : Calculate an aggregate pool of indi rect PE RVUs for all PFS services by adding the product of the indirect PE allo cators for a service from Step 8 and the

utilization data for that service. For CY 2014, we adjusted the indirect cost pool in proportion to the change in the PE share in th e revised MEI, as discussed in section II.D.

of this final rule with comment period. Step 11 : Using the results of Step 9 and Step 10, calculate an indirect PE

### CMS-1600-FC 36

adjustment so that the aggregate indir ect allocation does not exceed the available aggregate indirect PE RVUs and apply it to indirect allocators calculated in Step 8. Calculate the indirect practice cost index. Step 12 : Using the results of Step 11, calculate aggr egate pools of specialty-specific adjust ed indirect PE allocators for a ll PFS services for a specialty by adding the product of the adjusted indirect PE allocator for each service and the

utilization data for that service. Step 13 : Using the specialty-specific indirect PE/HR data, calculate specialty-specific aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the indirect PE/HR fo r the specialty, the physician time for the service, and the specialty's utilization for the service across all services furnished by the specialty. Step 14 : Using the results of Step 12 and St ep 13, calculate the specialty-specific indirect PE scaling factors. Step 15 : Using the results of Step 14, calculate an indirect practice cost index at the specialty level by dividing each specialty -specific indirect scaling factor by the average indirect scaling fact or for the entire PFS. Step 16 : Calculate the indirect practice cost index at the service level to ensure the capture of all indirect cost s. Calculate a weighted aver age of the practice cost index values for the specialties that furnish the service. (Note : For services with TCs and PCs, we calculate the indirect practice cost index across the global serv ice, PCs, and TCs. Under this method, the indirect practice cost index for a given service (for example, echocardiogram) does not vary by th e PC, TC, and global service.)

### CMS-1600-FC 37

Step 17 : Apply the service level indirect prac tice cost index calc ulated in Step 16 to the service level adjusted indirect allocators calculated in Step 11 to get the indirect PE

RVUs. (4) Calculate the Final PE RVUs Step 18 : Add the direct PE RVUs from Step 6 to the indirect PE RVUs from Step 17 and apply the final PE budget neutrali ty (BN) adjustment and the MEI revision adjustment. The final PE BN adjustment is calculate d by comparing the results of Step 18 to the current pool of PE RVUs (prior to the adjustments corresponding with the MEI

revision described in section II.D . of this final rule with comment period). This final BN adjustment is required to redi stribute RVUs from step 18 to all PE RVUs in the PFS, and because certain specialties are excluded fr om the PE RVU calculation for ratesetting purposes, but we note that all sp ecialties are included for pur poses of calculating the final BN adjustment. (See “Specialties excluded fr om ratesetting calculation” later in this section.) (5) Setup File Information

• Specialties excluded from ratesetting calculation : For the purposes of calculating the PE RVUs, we exclude certain specialties, such as certain nonphysician practitioners paid at a pe rcentage of the PFS and low- volume specialties, from the calculation. These specialties are include d for the purposes of calculating the BN adjustment. They are displayed in Table 1.

### CMS-1600-FC 38

TABLE 1: Specialties Excluded From Ratesetting Calculation Specialty Code Specialty Description 49 Ambulatory surgical center 50 Nurse practitioner 51 Medical supply company with certified orthotist 52 Medical supply company with certified prosthetist 53 Medical supply company with certified prosthetist-orthotist 54 Medical supply company not included in 51, 52, or 53. 55 Individual certified orthotist 56 Individual certified prosthestist 57 Individual certified prosthetist-orthotist 58 Individuals not included in 55, 56, or 57 59 Ambulance service supplier, e.g., privat e ambulance companies, funeral homes, etc. 60 Public health or welfare agencies 61 Voluntary health or charitable agencies 73 Mass immunization roster biller 74 Radiation therapy centers 87 All other suppliers (e.g., drug and department stores) 88 Unknown supplier/provider specialty 89 Certified clinical nurse specialist 95 Competitive Acquisition Program (CAP) Vendor 96 Optician 97 Physician assistant A0 Hospital A1 SNF A2 Intermediate care nursing facility A3 Nursing facility, other A4 HHA A5 Pharmacy A6 Medical supply company with respiratory therapist A7 Department store 1 Supplier of oxygen and/or oxygen related equipment 2 Pedorthic personnel 3 Medical supply company w ith pedorthic personnel

● Crosswalk certain low volume physician specialties : Crosswalk the utilization of certain specialties with relatively low PFS utilization to the associated specialties.

• Physical therapy utilization : Crosswalk the utilizat ion associated with all

### CMS-1600-FC 39

physical therapy services to the sp ecialty of physical therapy.

• Identify professional and technical serv ices not identified under the usual TC

and 26 modifiers : Flag the services that are PC a nd TC services, but do not use TC and 26 modifiers (for example, elec trocardiograms). This flag associates the PC and TC with the associated global code for use in creati ng the indirect PE RVUs . For example, the professional service, CPT code 93010 (Electro cardiogram, routine EC G with at least 12 leads; interpretation and report only), is associated with the global service, CPT code 93000 (Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report).

• Payment modifiers : Payment modifiers are accounted for in the creation of the file consistent with current payment policy as implemented in claims processing. For example,

services billed with the assist ant at surgery modifier are paid 16 percent of the PFS amount for that service; therefore, the uti lization file is modified to only account for 16 percent of any service that contains the assistant at surgery m odifier. Similarly, for t hose services to which volume adjustments are made to account for the pa yment modifiers, time adjustments are applied as well. For time adjustments to surgical serv ices, the intraoperative portion in the physician time file is used; where it is not present, the intraoperative percentage from the payment files used by contractors to process Medicare claims is used instead. Where neither is available, we use the payment adjustment ratio to adjust the time accordingly. Table 2 details the manner in which the modifiers are applied. TABLE 2: Application of Paymen t Modifiers to Utilization Files Modifier Description Volume Adjustment Time Adjustment 80,81,82 Assistant at Surgery 16% Intraoperative portion

### CMS-1600-FC 40

Modifier Description Volume Adjustment Time Adjustment AS Assistant at Surgery – Physician Assistant 14% (85% * 16%) Intraoperative portion 50 or LT and RT Bilateral Surgery 150% 150% of physician time 51 Multiple Procedure 50% Intraoperative portion 52 Reduced Services 50% 50% 53 Discontinued Procedure 50% 50% 54 Intraoperative Care only Preoperative + Intraoperative Percentages on the payment files used by Medicare contractors to process Medicare claims Preoperative + Intraoperative portion

55 Postoperative Care only Postoperative Percentage on the payment files used by Medicare contractors to process Medicare claims Postoperative portion

62 Co-surgeons 62.5% 50% 66 Team Surgeons 33% 33%

We also make adjustments to volume and time that correspond to other payment rules, including special multiple procedure endoscopy ru les and multiple procedure payment reductions (MPPR). We note that section 1848(c)(2)(B)(v) of the Act exem pts certain reduced payments for multiple imaging procedures and multiple th erapy services from the BN calculation under section 1848(c)(2)(B)(ii)(II ) of the Act. These MPPRs are not included in the development of

the RVUs. For anesthesia services, we do not apply adjustments to volume since the average allowed charge is used when simulating RVUs, and therefore, includes all adjustments. A time adjustment of 33 percent is made only for medical direction of two to four cases since that is the only situation where time units are duplicative.

### CMS-1600-FC 41

● Work RVUs : The setup file contains the work RVUs from this final rule with comment period. (6) Equipment Cost Per Minute The equipment cost per minute is calculated as: (1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 + interest rate)^ life of equipment)))) + maintenance)

Where: minutes per year = maximum minutes per ye ar if usage were continuous (that is, usage = 1); generally 150,000 minutes. usage = variable, see discussion below. price = price of the particular piece of equipment. life of equipment = useful life of th e particular piece of equipment. maintenance = factor for maintenance; 0.05. interest rate = variable, see discussion below. Usage : We currently use an equi pment utilization rate assump tion of 50 percent for most equipment, with the exception of expensiv e diagnostic imaging equipment. For CY 2013, expensive diagnostic imaging equipment, which is equipment priced at over $1 million (for example, computed tomography (CT) and magnetic resonance imaging (MRI) scanners), we use an equipment utilization rate assumption of 75 percent. Section 1848(b) (4)(C) of the Act, as modified by section 635 of the ATRA), requires that for fee schedules established for CY 2014 and subsequent years, in the methodology for de termining PE RVUs fo r expensive diagnostic imaging equipment, the Secretary shall use a 90 percent assumption. The provision also requires that the reduced expenditures attr ibutable to this change in th e utilization rate for CY 2014 and

### CMS-1600-FC 42

subsequent years shall not be taken into acc ount when applying the BN limitation on annual adjustments described in section 1848(c)(2)(B)(ii)(II ) of the Act. We are applying the 90 percent utilization rate assumption in CY 2014 to all of the services to which the 75 percent equipment utilization rate assumption applie d in CY 2013. These services ar e listed in a file called “CY 2014 CPT Codes Subject to 90 Percent Usage Ra te,” available on the CMS website under

downloads for the CY 2014 PFS final rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Ser vice-Payment/PhysicianFeeSched/PFS-FederalRegulation-Notices.html 

### . These codes are also displayed in Table 3. TABLE 3: CPT Codes Subject to 90 Percent Equipment Utilization Rate Assumption

CPT Code Short Descriptor 70336 Mri, temporomandibular joint(s) 70450 Ct head/brain w/o dye 70460 Ct head/brain w/ dye 70470 Ct head/brain w/o & w/ dye 70480 Ct orbit/ear/fossa w/o dye 70481 Ct orbit/ear/fossa w/ dye 70482 Ct orbit/ear/fossa w/o & w/ dye 70486 Ct maxillofacial w/o dye 70487 Ct maxillofacial w/ dye 70488 Ct maxillofacial w/o & w/ dye 70490 Ct soft tissue neck w/o dye 70491 Ct soft tissue neck w/ dye 70492 Ct soft tissue neck w/o & w/ dye 70496 Ct angiography, head 70498 Ct angiography, neck 70540 Mri orbit/face/neck w/o dye 70542 Mri orbit/face/neck w/ dye 70543 Mri orbit/face/neck w/o & w/dye 70544 Mr angiography head w/o dye 70545 Mr angiography head w/dye 70546 Mr angiography head w/o & w/dye 70547 Mr angiography neck w/o dye 70548 Mr angiography neck w/dye

### CMS-1600-FC 43

CPT Code Short Descriptor 70549 Mr angiography neck w/o & w/dye 70551 Mri brain w/o dye 70552 Mri brain w/dye 70553 Mri brain w/o & w/dye 70554 Fmri brain by tech 71250 Ct thorax w/o dye 71260 Ct thorax w/ dye 71270 Ct thorax w/o & w/ dye 71275 Ct angiography, chest 71550 Mri chest w/o dye 71551 Mri chest w/ dye 71552 Mri chest w/o & w/ dye 71555 Mri angio chest w/ or w/o dye 72125 CT neck spine w/o dye 72126 Ct neck spine w/dye 72127 Ct neck spine w/o & w/dye 72128 Ct chest spine w/o dye 72129 Ct chest spine w/dye 72130 Ct chest spine w/o & w/dye 72131 Ct lumbar spine w/o dye 72132 Ct lumbar spine w/dye 72133 Ct lumbar spine w/o & w/dye 72141 Mri neck spine w/o dye 72142 Mri neck spine w/dye 72146 Mri chest spine w/o dye 72147 Mri chest spine w/dye 72148 Mri lumbar spine w/o dye 72149 Mri lumbar spine w/dye 72156 Mri neck spine w/o & w/dye 72157 Mri chest spine w/o & w/dye 72158 Mri lumbar spine w/o & w/dye 72159 Mr angio spone w/o&w/dye 72191 Ct angiography, pelv w/o & w/ dye 72192 Ct pelvis w/o dye 72193 Ct pelvis w/ dye 72194 Ct pelvis w/o & w/ dye 72195 Mri pelvis w/o dye 72196 Mri pelvis w/ dye

### CMS-1600-FC 44

CPT Code Short Descriptor 72197 Mri pelvis w/o &w/ dye 72198 Mri angio pelvis w/ or w/o dye 73200 Ct upper extremity w/o dye 73201 Ct upper extremity w/dye 73202 Ct upper extremity w/o & w/dye 73206 Ct angio upper extr w/o & w/dye 73218 Mri upper extr w/o dye 73219 Mri upper extr w/dye 73220 Mri upper extremity w/o & w/dye 73221 Mri joint upper extr w/o dye 73222 Mri joint upper extr w/dye 73223 Mri joint upper extr w/o & w/dye 73225 Mr angio upr extr w/o&w/dye 73700 Ct lower extremity w/o dye 73701 Ct lower extremity w/dye 73702 Ct lower extremity w/o & w/dye 73706 Ct angio lower ext w/o & w/dye 73718 Mri lower extremity w/o dye 73719 Mri lower extremity w/dye 73720 Mri lower ext w/ & w/o dye 73721 Mri joint of lw r extre w/o dye 73722 Mri joint of lwr extr w/dye 73723 Mri joint of lwr extr w/o & w/dye 73725 Mr angio lower ext w or w/o dye 74150 Ct abdomen w/o dye 74160 Ct abdomen w/ dye 74170 Ct abdomen w/o & w/ dye

74174 Ct angiography, abdomen and pelvis w/o & w/ dye

74175 Ct angiography, abdom w/o & w/ dye 74176 Ct abdomen and pelvis w/o dye 74177 Ct abdomen and pelvis w/dye

74178 Ct abdomen and pelvis w/ and w/o dye 74181 Mri abdomen w/o dye 74182 Mri abdomen w/ dye 74183 Mri abdomen w/o and w/ dye 74185 Mri angio, abdom w/ or w/o dye

### CMS-1600-FC 45

CPT Code Short Descriptor 74261 Ct colonography, w/o dye 74262 Ct colonography, w/ dye 75557 Cardiac mri for morph 75559 Cardiac mri w/stress img 75561 Cardiac mri for morph w/dye 75563 Cardiac mri w/stress img & dye 75565 Card mri vel flw map add-on 75571 Ct hrt w/o dye w/ca test 75572 Ct hrt w/3d image 75573 Ct hrt w/3d image, congen 75574 Ct angio hrt w/3d image 75635 Ct angio abdominal arteries 76380 CAT scan follow up study 77058 Mri, one breast 77059 Mri, broth breasts 77078 Ct bone density, axial 77084 Magnetic image, bone marrow

### CMS-1600-FC 46

Comment: Several commenters objected to the statutorily-mandated change in equipment utilization rate assumptions, but none provided evidence that CMS has authority to use a different equipment ut ilization assumption for these services. Response: As mandated by statute, we are finalizing our proposed change in the equipment utilization rate for these services.

Interest Rate : In the CY 2013 final rule with comment period (77 FR 68902), we updated the interest rates used in developing an equipment cost per minute calculation.

The interest rate was based on the Sma ll Business Administration (SBA) maximum interest rates for different categories of lo an size (equipment cost) and maturity (useful life). The interest rates are listed in Ta ble 4. (See 77 FR 68902 for a thorough discussion of this issue.)

TABLE 4: SBA Maximum Interest Rates

Price Useful Life Interest Rate <$25K <7 Years 7.50% $25K to $50K <7 Years 6.50% >$50K <7 Years 5.50% <$25K 7+ Years 8.00% $25K to $50K 7+ Years 7.00% >$50K 7+ Years 6.00%

See 77 FR 68902 for a thorough discussion of this issue.CMS-1600-FC 47TABLE 5: Calculation of PE RVUsunder Methodology for Selected CodesStep Source Formula 99213Officevisit, estNonfacility33533CABG,arterial,singleFacility71020Chest xrayNonfacility71020-TCChestx-ray,Nonfacility71020-26Chest xray,Nonfacility93000ECG,complete,Nonfacility93005ECG,tracingNonfacility93010ECG,reportNonfacility(1) Labor cost(Lab)Step 1 AMA13.32 77.525.745.74 0.005.105.10 0.00(2) Supply cost(Sup)Step 1 AMA2.98 7.343.393.39 0.001.191.19 0.00(3) Equipmentcost (Eqp)Step 1 AMA0.17 0.587.247.24 0.000.090.09 0.00(4) Direct cost(Dir)Step 1 =(1)+(2)+(3)16.48 85.4516.3816.38 0.006.386.38 0.00(5) Directadjustment (Dir.Adj.)Steps 2-4 Seefootnote*0.5511 0.5511 0.5511 0.5511 0.5511 0.5511 0.5511 0.5511(6) AdjustedLaborSteps 2-4 =Lab * DirAdj=(1)*(5)7.34 42.72 3.16 3.16 0.00 2.81 2.81 0.00(7) AdjustedSuppliesSteps 2-4 =Eqp * DirAdj=(2)*(5)1.64 4.05 1.87 1.87 0.00 0.66 0.66 0.00(8) AdjustedEquipmentSteps 2-4 =Sup * DirAdj=(3)*(5)0.10 0.32 3.99 3.99 0.00 0.05 0.05 0.00(9) AdjustedDirectSteps 2-4 =(6)+(7)+(8)9.08 47.09 9.03 9.03 0.00 3.52 3.52 0.00(10) ConversionFactor (CF)Step 5 PFS34.0230 34.0230 34.023034.0230 34.0230 34.0230 34.0230 34.0230(11) Adj. laborcost convertedStep 5 =(Lab * DirAdj)/CF=(6)/(10)0.22 1.26 0.09 0.09 0.00 0.08 0.08 0.00(12) Adj. supplycost convertedStep 5 =(Sup * DirAdj)/CF=(7)/(10)0.05 0.12 0.05 0.05 0.00 0.02 0.02 0.00(13) Adj.equipment costconvertedStep 5 =(Eqp * DirAdj)/CF=(8)/(10)0.00 0.01 0.12 0.12 0.00 0.00 0.00 0.00(14) Adj. directcost convertedStep 5 =(11)+(12)+(13)0.27 1.38 0.27 0.27 0.00 0.10 0.10 0.00CMS-1600-FC 48Step Source Formula 99213Officevisit, estNonfacility33533CABG,arterial,singleFacility71020Chest xrayNonfacility71020-TCChestx-ray,Nonfacility71020-26Chest xray,Nonfacility93000ECG,complete,Nonfacility93005ECG,tracingNonfacility93010ECG,reportNonfacility(15) Work RVU Setup File PFS0.97 33.75 0.22 0.00 0.22 0.17 0.00 0.17(16) Dir_pct Steps 6,7 Surveys0.31 0.18 0.31 0.31 0.31 0.31 0.31 0.31(17) Ind_pct Steps 6,7 Surveys0.69 0.82 0.69 0.69 0.69 0.69 0.69 0.69(18) Ind. Alloc.Formula (1stpart)Step 8 See Step 8((14)/(16))*(17)((14)/(16))*(17)((14)/(16))*(17)((14)/(16))*(17)((14)/(16))*(17)((14)/(16))*(17)((14)/(16))*(17)((14)/(16))*(17)(19) Ind.Alloc.(1st part)Step 8 See 180.81 6.51 0.65 0.65 0 0.26 0.26 0(20) Ind. Alloc.Formula (2ndpart)Step 8 See Step 8(15) (15) (15+11) (11)(15) (15+11) (11) (15)(21) Ind.Alloc.(2nd part)Step 8 See 200.97 33.750.310.090.220.250.080.17(22) IndirectAllocator (1st +2nd)Step 8 =(19)+ (21)1.7840.260.960.740.220.510.340.17(23) IndirectAdjustment(Ind. Adj.)Steps 9-11 SeeFootnote**0.3848 0.38480.38480.38480.38480.38480.38480.3848(24) AdjustedIndirectAllocatorSteps 9-11 =Ind Alloc *Ind Adj0.68 15.490.370.290.080.200.130.07(25) Ind.Practice CostIndex (IPCI)Steps 12-161.070.760.950.950.950.910.910.91(26) AdjustedIndirectStep 17 = Adj.IndAlloc * PCI=(24)*(25)0.73 11.740.350.270.080.180.120.06(27) PE RVU Step 18 =(Adj Dir +Adj Ind) *Other Adj=((14)+(26)) *Other Adj)1.00 13.080.630.550.080.280.220.06Note: PE RVUs in Table 5, row 27, may not match Addendum B due to rounding.CMS-1600-FC 49Step Source Formula 99213Officevisit, estNonfacility33533CABG,arterial,singleFacility71020Chest xrayNonfacility71020-TCChestx-ray,Nonfacility71020-26Chest xray,Nonfacility93000ECG,complete,Nonfacility93005ECG,tracingNonfacility93010ECG,reportNonfacility*The direct adj = [current pe rvus * CF * avg dir pct]/[sum direct inputs] = [step2]/[step3]**The indirect adj = [current pe rvus * avg ind pct]/[sum of ind allocators] = [step9]/[step10]Note: The use of any particular conversion factor (CF) in Table 5 to illustrate the PE Calculation has no effect on the resulting RVUs.Note: The Other Adjustment includes an adjustment for the equipment utilization change.

### CMS-1600-FC 50

3. Adjusting RVUs to Match PE Share of the Medicare Economic Index (MEI) For CY 2014, as explained in detail in sect ion II.D of this final rule with comment period, we are finalizing revi sions to the MEI based on the recommendations of the MEI Technical Advisory Panel (TAP). The MEI is an index that measures the price change of the inputs used to furnish physician services. This measure was authorized by statute and is developed by the CMS Office of the Actuar y. We believe that the MEI is the best

measure available of the rela tive weights of the three components in payments under the PFS – work, PE and malpractice. Accordingl y, we believe that to assure that the PFS payments reflect the resources in each of these components as required by section 1848(c)(3) of the Act, the RVUs used in deve loping rates should reflect the same weights in each component as the MEI. We proposed to accomplish this by holding the work RVUs constant and adjusting the PE RVUs , the MP RVUs and the CF to produce the appropriate balance in RVUs among components and payments. In the proposed rule and above, we detailed the steps necessary to accomplish this result (see steps 3, 10, and 18). This proposed adjustment is consistent with our longstandin g practice to make adjustments to match the RVUs for the PFS co mponents with the MEI cost share weights for the components, including the adjustment s described in the CY 1999 PFS Final Rule (63 FR 58829), CY 2004 PFS Final Rule 68 FR 63246-63247, and CY 2011 PFS Final Rule (75 FR 73275). We note that the revisions to the MEI finalized in section II.D of

this final rule are made to the MEI as rebased for CY 2011, and that the RVUs we proposed for CY 2014 reflect the weights of the MEI as rebased for CY 2011 and revised for CY 2014. As such, the relationships among the work, PE, and malpractice RVUs under the PFS are aligned with those under the revised 2006-based MEI.

### CMS-1600-FC 51

Comment: Several commenters requested ex planation regarding the relationship between the proposed MEI revision and the proposed RVUs. One commenter suggested

that it would be better to scale the work R VUs upward instead of scaling the PE RVUs downward to achieve the weighting adjustment. Response: The change in the relationshi p among work, PE, and malpractice RVUs could be accomplished by applying adjustments directly to the work, PE, and malpractice RVUs or by holding the RVUs constant for one component, scaling the other two components and applying a budget neutral ity adjustment to the conversion factor. We proposed to make the adjustment by holdi ng work RVUs constant consistent with prior adjustments and in response to ma ny public comments made during previous rulemaking (see, for example, 75 FR 73275) indicating a strong preference and persuasive arguments in favor of keeping the work RVUs stable over time since work RVUs generally only change based on reviews of particular services. In contrast, PE RVUs are developed annually, irrespective of changes in the direct PE inputs for particular services, so that sc aling of PE RVUs is less disrup tive to the public review of values that determine PFS payment rates. We took this approach for the CY 2014 adjustment because we believe the methodol ogy and reasons for making the adjustment in this way are settled and remain valid. Fo r these reasons, we are finalizing the proposed rebasing of the relationship among RVU components by holding the work RVUs constant, decreasing the PE RVUs and the MP RVUs, and applying a budget neutrality adjustment to the CF.

Comment: Several commenters argued that the RVU components should not be weighted consistent with the revised MEI as it was it was entirely appropriate to include

### CMS-1600-FC 52

nurse practitioner and physician assistan t wages in the physician practice expense calculation because physicians often employ nur se practitioners, physician assistants and

other non

‐ physicians.

Response : We refer commenters to section II. D. of the final rule with comment period regarding the appropriate classificat ion of wages in the MEI. Regarding classification of labor input s in the RVU components, th e decision as to whether something should be considered a practi ce expense or work under the PFS does not depend on the employment status of the health care professional furnishing the service. Resource inputs are classified based on whether they relate to the “work” or “practice expense” portion of a service. The clinical labor portion of the dire ct PE input database includes the portion of services provided by practitioners who do not bill Medicare directly, such as registered nurses and other clinical labor. We do not include in this category the costs of nurse practitioners and others who can bill Medicare directly. Under the PFS, the work component of a serv ice is valued based on the work involved in furnishing the typical service. The value is the same whether the service is billed by a physician or another practitioner (such as a nur se practitioner or phys ician assistant) who is permitted to bill Medicare directly for the service. We acknowledge that these practitioners may perform a va riety of services in a physic ian office – some of which would be included in the work portion .and ot hers that would be included in the PE portion as clinical labor. Similarly, it is not unusual for physicians to hire other

### CMS-1600-FC 53

physicians to work in their practices, but we likewise do not consider those costs to be part of the clinical labor that is included as a practice expense. Since values for services under the PFS are based upon the typical case ra ther than the type of practitioner that performs the service in a particular situation, we continue to believe it is appropriate to include the work performed by professionals eligib le to bill Medicare directly in the work component of PFS payments, even in cases when they are employed by physicians. Additionally, we note that none of the commenters who questioned the appropriate accounting for the work of thes e nonphysician practitioners addressed how it would be appropriate to treat the costs for these nonphysician practitioners differently for purposes of calculating RVUs and the MEI. The labor of nonphysician practitioners who can bill independently for their services under the PFS is considered as work under the physician fee schedule since these services are also furnished by physicians and the RVUs for these PFS services do not vary ba sed on whether furnished by a physician or nonphysician. As such, we believe that the chan ge in the MEI to sh ift these costs from the PE to the work category as described in se ction II.D. of this final rule with comment period is entirely consistent w ith the PFS in this regard. We would also note that the change in the MEI was recommended by the MEI TAP that identified a discrepancy between how the work of non-physic ian practitioners is captured in the RVUs, how billing works under the PFS, and how costs are accounted for in the MEI. With the change in the MEI bei ng finalized in this final rule with comment period, we continue to believe that the ME I weights are the best reflection of the PFS component weights, and we belie ve it is appropriate to fina lize this adjustment in the

RVUs as well.

### CMS-1600-FC 54

Comment: Several commenters strongly urged the agency, in adjusting weights among the PFS components to reflect the MEI cost we ight changes, to consider alternative methodologies that would mitigate the redistribution of RVUs from the PE to the work category. These commenters pointed out that the practi tioners who furnish services with a higher proportion of PE RVUs are hit hardest by these ch anges. These comments also suggested that CMS should consider postponing this adjustment of the RVUs until such a methodology can be

vetted. Several commenters suggested that, given the magnitude of the reductions, CMS should consider a phase-in of this change. These comm enters pointed out that CMS has used a phase-in approach in the past to mitigate the effects of methodological changes to the calculation ofpayment rates under the MPFS, including a four-year phase-in of the transition from the topdown to the bottom-up methodology of calculating direct PE RVUs. Response: We appreciate that the increase in the work RVUs relative to PE RVUs will generally result in lower payments for practitioners who furnish more services with a higher proportion of PE RVUs. Howeve r, we continue to believe that the MEI cost share weights are the be st reflection of the PFS compone nt weights. The CY 2014 revisions to the MEI, following the rebasi ng for 2011 and consideration by the MEI TAP,

reflect the best available information. As such, we believe that the relationship among the RVU components should conform to the revi sed cost weights adopted for the MEI. While we understand and recognize the general preference to avoid significant year-toyear reductions in Medicare payment, includi ng practitioners’ intere sts in phasing in any reduction, and we acknowledge that this revision of the PFS com ponent weights results in an increase in work RVUs relative to PE RVUs, we note that the 2011 rebasing of the MEI resulted

### CMS-1600-FC 55

in a change of greater magnitude that increased the PE RVUs relative to work RVUs. That change was not phased in. Based on considera tion of these comments, we are finalizing as proposed the adjustment to the relationship am ong the work, PE, and malpractice component

RVUs to reflect the MEI cost sh are being finalized in this fina l rule with comment period, with the necessary adjustment to the conversion fact or and to PE and MP RVUs to maintain budget neutrality. 4. Changes to Direct PE Inputs for Specific Services In this section, we discuss other CY 2014 proposals and revisi ons related to direct PE inputs for specific services. Th e final direct PE inputs are in cluded in the final rule with comment period CY 2014 direct PE input database , which is available on the CMS website under

under downloads for the CY 2014 PFS fi nal rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-fo r-Service-Payment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html

. a. Anomalous Supply Inputs In the CY 2013 PFS final rule with comment pe riod, we established interim final direct PE inputs based on acceptance, with refinement, of recommendations submitted by the AMA RUC. Although we generally address public comment s on the current year’s interim final direct PE inputs in the following year’s final rule w ith comment period, several commenters raised an issue regarding anomalous supply items for codes that were not subject to comment in the CY 2013 final rule with comment period. Since cha nges were being suggested to codes not subject to comment, we believed these comments were be st addressed through pro posed revisions to the direct PE inputs in the propos ed rule allowing the opportunity for public comment before implementation.

### CMS-1600-FC 56

For the CY 2013 interim final direct PE inputs for a series of codes that describe six levels of surgical pathology services (CPT codes 88300, 88302, 88304, 88305, 88307, 88309), we did not accept the AMA RUC recommendation to create two new direct PE supply inputs

because we did not consider thes e items to be disposable supp lies (77 FR 69074) and thus they did not meet the criteria for direct PE inputs. These items were called “specimen, solvent, and formalin disposal cost,” and “c ourier transportation costs.” In the CY 2013 PFS final rule with comment period, we explained that neither the specimen and supply disposal nor courier costs for transporting specimens are appropriately considered disposable medical supplies. Instead,

we stated these costs are incor porated into the PE RVUs for th ese services through the indirect

PE allocation. We also noted th at the current direct PE inputs for these and similar services

across the PFS do not include these kinds of costs as disposable supplies. Several commenters noted that, contrary to our assertion in the CY 2013 final rule with comment period, there are items incorporated in the direct PE input database as “supplies” that are no more disposable supplies than the ne w items recommended by the AMA RUC for the surgical pathology codes. Thes e commenters identified seven suppl y inputs in particular that they believe are analogous to the items that we did not accept in establishing CY 2013 interim final direct PE inputs. Thes e items and their associated HC PCS codes are listed in Table 6. TABLE 6: Items Identified by Commenters

CMS Supply Code Item Description Affected CPT Codes SK106 device shipping cost 93271, 93229, 93268 SK112 Federal Express cost (average across all zones) 64650, 88363, 64653 SK113 communication, wire less per service 93229 SK107 fee, usage, cycletron/accelerator, gammaknife, Lincac SRS System 77423, 77422 SK110 fee, image analysis 96102, 96101, 99174

### CMS-1600-FC 57

CMS Supply Code Item Description Affected CPT Codes SK111 fee, licensing, computer, psychology 96102, 96101, 96103, 96120

SD140 bag system, 1000ml (for angiographywaste fluids) 93451,93452,93453,93454, 93455,93456,93457,93458, 93459,93460,93461

We reviewed each of these items for consistency with the general principles of the PE methodology regarding the categorization of all costs. Within the PE methodology, all costs other than clinical labor, dis posable supplies, and medical equi pment are considered indirect

costs. For six of the items contained in Table 6, we agreed with the commenters that the items should not be considered disposable supplies. We believed that these items are more appropriately categorized as indirect PE costs, wh ich are reflected in the a llocation of indirect PE RVUs rather than through direct PE inputs. Th erefore, we proposed to remove the following six items from the direct PE input database for CY 2014: “device shipping cost” (SK106); “Federal Express cost (average across all zones)” (SK112); “communication, wireless per service” (SK113); “fee, usage, cycletr on/accelerator, gammaknife, Lincac SRS System” (SK107); “fee, image analysis” (SK110); and “fee, li censing, computer, psychology” (SK111). In the case of the supply item called “bag sy stem, 1000ml (for angiography waste fluids)” (SD140), we did not agree with the commenters that this item is analogous to the specimen disposal costs recommended for th e surgical pathology codes. This supply input represents only the costs of the disposable material items asso ciated with the removal of waste fluids that typically result from a particular procedure. In contrast, the item recommended by the AMA RUC for surgical pathology consisted of an amor tized portion of a speci men disposal contract

that includes costs for resources such as labor and transportation. Fu rthermore, we did not believe that the specimen disposal contract is attributable to individual procedures within the

### CMS-1600-FC 58

established PE methodology. We believe that a dis posable supply is one that is attributable, in its entirety, to an individual patient for a partic ular service. An amor tized portion of a specimen disposal contract does not meet these criteria. Accordingly, as stated in the CY 2013 final rule with comment period, we did not accept the AMA RUC recommendation to create a new supply item related to specimen disposal costs. We believe that many physician offices and other nonfacility settings where Medicare beneficiaries receive services incur costs re lated to waste management or other service contra cts, but none of these costs are currently incorporated into the PE methodology as disposable supplies. Instead, these costs are appropriately categorized as indirect costs, which are reflect ed in the PE RVUs through the allocation of indirect PE. We

clarified that we believe that s upply costs related to specimen dis posal attributable to individual services may be appropriately ca tegorized as disposable supplies , but that specimen disposal costs related to an allocated portion of service contracts cannot be attr ibuted to individual services and should not be incorporat ed into the direct PE input data base as disposable supplies. Moreover, because we do not agree with comm enters that the “bag system, 1000ml (for angiography waste fluids)” (SD140) is analogous to a specimen dis posal contract for the reasons state above, we continued to beli eve that SD140 is a direct expe nse. Accordingly, we did not propose to remove SD140 from the direct PE input database.

Comment: One commenter objected to CMS’s pr oposal to remove the “device shipping cost” (SK106) and “communication, wireless per service” (SK113) from the direct PE input database as they are more analogous to the an giography waste fluid bag system than the other items since both items represent costs associated with a specific procedure rather than an

amortization of costs associated with a service contract. Response: We agree with the commenter that bo th of these items may represent costs

### CMS-1600-FC 59

associated with a specific procedure. However, as we articulated in making the proposal to remove these items, we do not believe these items are disposable supplies and we believe all costs other than clinical labor, disposable supplies, and medical equipment should be considered

indirect costs in order to ma intain consistency and relativity within the PE methodology. We believe that there are a variety of costs allocable to individual services that are appropriately considered part of indirect co st categories for purposes of th e PE methodology. Were all these included as direct PE inputs for services across the PFS, regardle ss of whether or not the items were reasonably described as clinical labor, disp osable supplies, or medical equipment, then the relationship between direct and indirect costs would be signif icantly skewed. This skewing could be compounded since the amount of indirect PE allocated to particular codes is partly determined by the amount of direct costs associat ed with the codes. Th erefore, the inaccurate

inclusion of indirect costs as direct costs would not only result in duplicative accounting for the items (as both indirect and direct PE costs) but al so an additional allocatio n of indirect PE based

on the item’s inclusion as a direct cost. Therefor e, we are finalizing removal of these items from the direct PE input database as proposed.

Comment: Several commenters suggested that CMS should change its understanding of direct and indirect practice expe nse items. One commenter sugge sted that all variable costs proportional to the number of services furnishe d per day be considered direct. Another commenter suggested that the only costs that can be considered i ndirect costs are those that are required by all services, those that do not vary from one service t ype to the next; and those that

are not based on service volume. Therefore CMS should allow all other recommended direct PE inputs to be allowed as direct PE inputs. Response: We note that there is a longsta nding PE methodology, established through

### CMS-1600-FC 60

notice and comment rulemaking that includes princi ples for determining whether an expense is

direct or indirect. Under the established PE methodology, whether or not a particular cost is variable has little bearing on the appropriate clas sification of a particular item as a direct or indirect cost. Although we have previously pointed out that the cu rrent methodology does not

accommodate costs that cannot be allo cated to particular services as direct costs, this does not mean that all costs that can be allocated to par ticular services are nece ssarily direct costs. Instead, a significant number of costs consider ed to be indirect for purposes of the PE methodology are variable costs prop ortional to the kind and number of services furnished each day. For example, administrative and clerical re source costs associated with medical billing are likely to be incurred with each service furnis hed. Presumably, practitioners incur greater

resource cost associated with administrative a nd clerical labor and supplies based on the volume of services furnished. Similarly, some kinds of services may require more administrative resources than others. Some complex services, for example, may require advance or follow-up administrative work that is not required for less complex services. General office expenses may also vary depending on the number and kind of serv ices furnished. For example, practices that furnish a greater number of services to a greate r number of patients ge nerally require larger waiting rooms and additional waiting room furniture . Other services such as those that are furnished without having the patient present may not require patient waiting rooms at all. We note that some services require a different amount of electricity than others and some require more space than others. We believe that th e PE methodology accounts for these costs in the

allocation of indirect PE RVUs included in th e payment rate for each service furnished to

Medicare beneficiaries. We do not believe it would appropriate in the current methodology to

include all such variable costs as direct PE inputs. Therefore, we do not agree with commenters’

### CMS-1600-FC 61

assertions regarding the appropriateness of these ite ms as direct costs. Instead, we continue to believe that these costs represent indirect costs that are incorporated in the PE RVUs for these services through the allocation of indirect PE RVUs. We also direct readers to section II.E.2.b.

of this final rule for a discussion of commen ts received regarding the CY 2013 interim final direct PE inputs for surgical pathology services. After consideration of these comments, we are finalizing our proposal to remove the specified anomalous supply items from the direct PE input database. The CY 2014 direct PE input database and the PE RVUs displayed in Addendum B of this final rule with comment period reflect the finalization of this proposal. b. Direct PE Input Refinements based on Routine Data Review In reviewing the direct PE input database, we identified several discrepancies that we proposed to address for CY 2014. In the following paragraphs, we identify the nature of these discrepancies, the affected codes, and the ad justments proposed in the CY 2014 proposed rule direct PE input database. As part of our intern al review of information in the direct PE input database, we identified supply items that appeared without quan tities for CPT code 51710 (Change of cystostomy tube; complicated). U pon reviewing these items we believed that the

code should include the items at the quantities listed in Table 7. TABLE 7: Supply Items and Qu antities for CPT code 51710

Supply Code Description of Supply Item NF Quantity SA069 tray, suturing 1.0 SB007 drape, sterile barrier 16in x 29in 1.0 SC029 needle, 18-27g 1.0 SC051 syringe 10-12ml 1.0 SD024 catheter, Foley 1.0 SD088 Guidewire 1.0

### CMS-1600-FC 62

Supply Code Description of Supply Item NF Quantity SF036 suture, nylon, 3-0 to 6-0, c 1.0 SG055 gauze, sterile 4in x 4in 1.0 SG079 tape, surgical paper 1in (Micropore) 6.0 SH075 water, sterile inj 3.0 SJ032 lubricating jelly (K-Y) (5gm uou) 1.0 SJ041 povidone soln (Betadine) 20.0

Upon reviewing the direct PE inputs fo r CPT code 51710 and the related code 51705 (Change of cystostomy tube; simple), we also noted that the direct PE input database includes an

anomalous 0.5 minutes of clinical labor time in the post-service period. We believe that this small portion of clinical labor tim e is the result of a rounding erro r in our data and should be removed from the direct PE input database.

Comment : One commenter supported the inclus ion of the supply items for CPT code 51710. We received no comments regarding the ch ange in clinical labor time for codes 51710

and 51705. Response : Based on these comments and for the reasons stated, we are finalizing the

removal of these items in the CY 2014 final direct PE input database. During our review of the data, we noted an invalid supply code (SM037) that appears in the direct PE input database for CPT codes 88312 and 88313. Upon review of the code, we believe that the supply item called “wipes, lens cleaning (per wipe) (K imwipe)” (SM027) should

be included for these codes inst ead of the invalid supply code. We did not receive any comments regarding this proposed revision. Therefore, we are finalizing th is revision as proposed for CY

2014. Additionally, we conducted a rout ine review of the codes valu ed in the nonfacility setting

for which moderate sedation is inhe rent in the procedure. Consiste nt with the sta ndard moderate

### CMS-1600-FC 63

sedation package finalized in the CY 2012 PFS fi nal rule with comment period (76 FR 73043), we have made minor adjustments to the nurse ti me and equipment time for 18 of these codes. These codes appear in Table 8.

Comment: One commenter agreed with this pro posal to standardize moderate sedation inputs for codes valued in th e nonfacility setting. We received no comments on the correction on the invalid supply item. Response: After considering this comment, we are finalizing the minor adjustments to the moderate sedation inputs as proposed. Th e CY 2014 direct PE data base reflects these adjustments. TABLE 8: Codes with Minor Adjustme nts to Moderate Sedation Inputs

CPT Code Descriptor 31629 Bronchoscopy/needle bx each 31645 Bronchoscopy clear airways 31646 Bronchoscopy reclear airway 32405 Percut bx lung/mediastinum 32550 Insert pleural cath 35471 Repair arterial blockage 37183 Remove hepatic shunt (tips) 37210 Embolization uterine fibroid 43453 Dilate esophagus 43458 Dilate esophagus 44394 Colonoscopy w/snare 45340 Sig w/balloon dilation 47000 Needle biopsy of liver 47525 Change bile duct catheter 49411 Ins mark abd/pel for rt perq 50385 Change stent via transureth 50386 Remove stent via transureth 57155 Insert uteri tandem/ovoids 93312 Echo transesophageal 93314 Echo transesophageal G0341 Percutaneous islet celltrans

### CMS-1600-FC 64

c. Adjustments to Pre-Service Clinical Labor Minutes As we noted in the CY 2014 PFS proposed rule, we had recently received a recommendation from the AMA RUC regarding appropr iate pre-service clinical labor minutes in the facility setting for codes with 000-day global periods. In general, the AMA RUC recommended that codes with 000-day global period include a maximu m of 30 minutes of clinical labor time in the pre-se rvice period in the facility se tting. The AMA RUC identified 48 codes that currently include more clinical la bor time than this recommended maximum and provided us with recommended pre-service clinical labor minutes in the facility setting of 30

minutes or fewer for these 48 codes. We re viewed the AMA RUC’s recommendation and agree that the recommended reductions would be appropri ate to maintain relativity with other 000-day global codes. Therefore, we proposed to amend the pre-service clinical labor minutes for the codes listed in Table 9, consistent with the AMA RUC recommendation.

Comment: One commenter supported this proposal based on the AMA RUC’s

recommendation. Response: After considering the su pporting comment, we are fina lizing these changes as proposed. The CY 2014 direct PE input database reflects these changes. TABLE 9: 000-Day Global Codes with Changes to Pre-service CL Time

CPT Code Short Descriptor Existing CL PreService Facility Minutes CL Pre-Service Facility Minutes (AMA RUC Recommendation) 20900 Removal of bone for graft 60 30 20902 Removal of bone for graft 60 30 33224 Insert pacing lead & connect 35 30 33226 Reposition l ventric lead 35 30 36800 Insertion of cannula 60 0 36861 Cannula declotting 37 0

### CMS-1600-FC 65

CPT Code Short Descriptor Existing CL PreService Facility Minutes CL Pre-Service Facility Minutes (AMA RUC Recommendation) 37202 Transcatheter therapy infuse 45 0 50953 Endoscopy of ureter 60 30 50955 Ureter endoscopy & biopsy 60 30 51726 Complex cystometrogram 41 30 51785 Anal/urinary muscle study 34 30 52250 Cystoscopy and radiotracer 37 30 52276 Cystoscopy and treatment 32 30 52277 Cystoscopy and treatment 37 30 52282 Cystoscopy implant stent 31 30 52290 Cystoscopy and treatment 31 30 52300 Cystoscopy and treatment 36 30 52301 Cystoscopy and treatment 36 30 52334 Create passage to kidney 31 30 52341 Cysto w/ureter stricture tx 42 30 52342 Cysto w/up stricture tx 42 30 52343 Cysto w/renal stricture tx 42 30 52344 Cysto/uretero stricture tx 55 30 52345 Cysto/uretero w/up stricture 55 30 52346 Cystouretero w/renal strict 55 30 52351 Cystouretero & or pyeloscope 45 30 52352 Cystouretero w/stone remove 50 30 52353 Cystouretero w/lithotripsy 50 30 52354 Cystouretero w/biopsy 50 30 52355 Cystouretero w/excise tumor 50 30 54100 Biopsy of penis 33 30 61000 Remove cranial cavity fluid 60 15 61001 Remove cranial cavity fluid 60 15 61020 Remove brain cavity fluid 60 15 61026 Injection into brain canal 60 15 61050 Remove brain canal fluid 60 15 61055 Injection into brain canal 60 15 61070 Brain canal shunt procedure 60 15 62268 Drain spinal cord cyst 36 30

### CMS-1600-FC 66

CPT Code Short Descriptor Existing CL PreService Facility Minutes CL Pre-Service Facility Minutes (AMA RUC Recommendation) 67346 Biopsy eye muscle 42 30 68100 Biopsy of eyelid lining 32 30 93530 Rt heart cath congenital 35 30 93531 R & l heart cath congenital 35 30 93532 R & l heart cath congenital 35 30 93533 R & l heart cath congenital 35 30 93580 Transcath closure of asd 35 30 93581 Transcath closure of vsd 35 30

d. Price Adjustment for Laser Diode As we noted in the CY 2013 PFS proposed rule, it has come to our attention that the price associated with the equipment item called “laser , diode, for patient posi tioning (Probe)” (ER040) in the direct PE input database is $7,678 in stead of $18,160 as listed in the CY 2013 PFS final rule with comment period (77 FR 68922). We proposed to revise the direct PE input database to reflect the corrected price.

Comment: Several commenters expressed support for this proposal. Response: We appreciate the commenters’ supp ort and have revised the CY 2014 final direct PE input database as proposed. e. Direct PE Inputs for Stereotactic Radios urgery (SRS) Services (CPT Codes 77372 and 77373) Since 2001, Medicare has used HCPCS G-code s, in addition to the CPT codes, for stereotactic radiosurgery (SRS ) to distinguish robotic and no n-robotic methods of delivery.

Based on our review of the current SRS technolo gy, it is our understanding that most services currently furnished with linac-based SRS technol ogy, including services cu rrently billed using the non-robotic codes, incorporate some type of robot ic feature. Therefore, we believe that it is

### CMS-1600-FC 67

no longer necessary to continue to distinguish robotic vers us non-robotic linac-based SRS through the HCPCS G-codes. For purposes of the hospital outpatient prospective payment system (OPPS), we proposed to replace the ex isting four SRS HCPCS G-codes G0173 (Linear accelerator based stereotactic radiosurgery, co mplete course of therapy in one session), G0251(Linear accelerator based st ereotactic radiosurgery, delive ry including collimator changes and custom plugging, fractionated treatment, all lesions, per session, maximum five sessions per course of treatment), G0339 (Image-guided robo tic linear accelerator -based stereotactic radiosurgery, complete course of therapy in one session or first session of fractionated treatment), and G0340 (Image-guided robotic linear accelerator-based stereo tactic radiosurgery, delivery including collimator changes and cust om plugging, fractionated treatment, all lesions, per session, second through fifth se ssions, maximum five sessions per course of treatment), with the SRS CPT codes 77372 (Radiation treatment de livery, stereotactic radiosurgery (SRS), complete course of treatment of cranial lesion(s ) consisting of 1 session; linear accelerator based) and 77373 (Stereotactic body radiati on therapy, treatment delivery, per fraction to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions) that do not distinguish

between robotic and non-robotic methods of deliver y. We refer readers to section II.C.3 of the CY 2014 OPPS proposed rule for more discussion of that proposal. We also refer readers to the CY 2007 OPPS final rule (71 FR 68023 through 68026) for a detailed discussion of the history

of the SRS codes.

Two of the four current SRS G- codes are paid in the nonfaci lity setting through the PFS. These two codes, G0339 and G0340, describe robotic SRS treatment delivery and are contractorpriced. CPT codes 77372 and 77373, which describe SRS treatment deliver y without regard to the method of delivery, are curren tly paid in the nonfacility se tting based on resource-based

### CMS-1600-FC 68

RVUs developed through the standard PE methodol ogy. We noted in the proposed rule that if the CY 2014 OPPS proposal were finalized, it would appear that there woul d no longer be a need

for G-codes to describe robotic SRS treatment and delivery. We did not propose to replace the contractor-priced G-codes for PFS payment but did seek comment from the public and stakeholders, including the AMA RUC, regarding whether or not the dir ect PE inputs for CPT codes 77372 and 77373 would continue to accurately estimate the resources used in furnishing typical SRS delivery were there no coding distin ction between robotic and non-robotic methods of delivery.

Comment : Several commenters, including the AM A RUC, responded to our request for information regarding whether the direct PE inputs for CPT codes 77372 and 77373 would continue to accurately estimate the resources used in furnishing typical SRS delivery were there no coding distinction between robotic and non-robo tic methods of delivery. Most commenters, including the AMA RUC, stated that the most recently recommended direct PE inputs for these services would accurately estimate the resources . One commenter suggested this was not the

case and that CMS should maintain the G-codes for purposes of PFS payment. Response : We appreciate stakehol ders’ responsiveness to our request for information. We will consider the information submitted in public comments as we consider future rulemaking for these codes. 2. Using OPPS and ASC Rate s in Developing PE RVUs We typically establish two sepa rate PE RVUs for services that can be furnished in either a nonfacility setting, like a physic ian’s office, or a facility setting, like a hospital. The nonfacility PE RVUs reflect all of the direct and indirect practice expenses involved in furnishing a particular service when the entire se rvice is furnished in a nonfacility setting. The

### CMS-1600-FC 69

facility PE RVUs reflect the direct and indirect practice expenses associated with furnishing a particular service in a setting su ch as a hospital or ASC where t hose facilities incur a portion or all of the costs and receive a separate Medi care payment for the service. When services are furnished in the facility se tting, such as a HOPD or an ASC, the total combined Medicare payment (mad e to the facility and the prof essional) typically exceeds the Medicare payment made for the same service wh en furnished in the physician office or other nonfacility setting. We believe that this paymen t difference generally reflects the greater costs

that facilities incur than those incurred by practitioners furnishi ng services in offices and other nonfacility settings. For exampl e, hospitals incur hi gher overhead costs becau se they maintain the capability to furnish services 24 hours a day and 7 days pe r week, generally furnish services to higher acuity patients than those who receive services in physicians’ offices, and have additional legal obligations su ch as complying with the Emergency Medical Treatment and Labor Act (EMTALA). Additionally, hospitals must meet conditions of participation and ASCs must meet conditions for coverage in order to participate in Medicare. However, we have found that for some serv ices, the total Medicare payment when the service is furnished in the physician office se tting exceeds the total Medicare payment when the

service is furnished in an HOPD or an ASC. When this occurs, we believe it is not the result of appropriate payment differentials between the services furnished in different settings. Rather, we

believe it is due to anomalies in the data we use under the PFS and in the application of our resource-based PE methodology to the particular services. The PFS PE RVUs rely heavily on the voluntary submission of information by individuals furnishing the service and who are paid at least in pa rt based on the data provided. Currently, we have little means to validate whethe r the information is accurate or reflects typical

### CMS-1600-FC 70

resource costs. Furthermore, in the case of cer tain direct costs, like the price of high-cost disposable supplies and expensive capital equipm ent, even voluntary information has been very

difficult to obtain. In some cases the PE RVUs are based upon single price quotes or one paid

invoice. We have addressed these issues extens ively in previous rulemaking (for example, 75 FR 73252). Such incomplete, small sample, potentially biased or inaccurate resource input costs may distort the resources used to develop nonfaci lity PE RVUs used in calculating PFS payment

rates for individual services. In addition to the accuracy issues with some of the physician PE resource inputs, the data used in the PFS PE methodology can often be outda ted. As we have previously noted (77 FR 68921) there is no practical means for CMS or stakeholders to engage in a complete simultaneous review of the input resource cost s for all HCPCS codes paid under the PFS on an annual or even regular basis. Thus, the inform ation used to estimate PE resource costs for PFS services is not routinely updated. Instead, we strive to maintain relativity by reviewing at the same time the work RVUs, physician time, and di rect PE inputs for a code, and reviewing all codes within families of codes where appropriate . Nonetheless, outdated resource input costs may distort RVUs used to develop nonfacility PFS payment rates for individual services. In the case of new medical devices for which a high grow th in the volume of a service as it diffuses into clinical practice may lead to a decrease in the cost of expe nsive items, outdated price inputs can result in signifi cant overestimation of resource costs. Such inaccurate resource input costs may distort the nonfacility PE RVUs used to calculate PFS payment rates for individual serv ices. As we have previously noted, OPPS payment rates are based on auditable hospital data and are updated annually. Given the differences in the validity of the data used to calculate payments under the PFS and OPPS, we

### CMS-1600-FC 71

believe that the nonfacility PFS payment rates for procedures that exceed those for the same procedure when furnished in a facility result fr om inadequate or inaccurate direct PE inputs, especially in price or time assumptions, as comp ared to the more accurate OPPS data. On these bases, we proposed a change in th e PE methodology beginning in CY 2014. To improve the accuracy of PFS nonfacility payment ra tes for each calendar year, we proposed to use the current year OPPS or ASC rates as a point of comparison in establishing PE RVUs for services under the PFS. In setting PFS rates, we proposed to compare the PFS payment rate for a service furnished in an office setting to the total combined Medica re payment to practitione rs and facilities for the same service when furnished in a hospital outpati ent setting. For services on the ASC list, we proposed to make the same comparison except we would use the ASC rate as the point of comparison instead of the OPPS rate. We proposed to limit the nonfacility PE RVUs for individual codes so that the total nonfacility PFS payment amount would not exceed the total combined am ount that Medicare would pay for the same code in the facility sett ing. That is, if the nonf acility PE RVUs for a code would result in a higher payment than the corresponding combined OPPS or ASC payment rate and PFS facility PE RVUs (when applicab le) for the same code, we would reduce the nonfacility PE RVU rate so that the total nonfacility payment doe s not exceed the total Medicare payment made for the service in the facility sett ing. To maintain the greatest consistency and transparency possible, we proposed to use the cu rrent year PFS conversion factor. Similarly, we proposed to use current year OPPS or ASC rates in the comparison. For services with no work RVUs, we proposed to compare the total nonfacility PFS payment to the OPPS payment rates directly since no PFS pa yment is made for these services when furnished in the facility setting.

### CMS-1600-FC 72

We proposed to exempt the following services from this policy:

● Services Without Separate OPPS Payment Rates : We proposed to exclude services without separately payable OPPS rates from th is methodical change since there would be no OPPS rate to which we could compare the PFS nonf acility PE RVUs. We note that there would

also be no ASC rate for these services since ASCs are only approved to furnish a subset of OPPS

services.

● Codes Subject to the DRA Imaging Cap : We proposed to exclude from this policy services capped at the OPPS paym ent rate in accordance with the Deficit Reduction Act of 2005 (DRA) (Pub. L. 109–171). The DRA provision limits PFS payment for most imaging procedures to the amount paid under the OPPS system. This policy applies to the technical component of imaging services, including X-ray, ultrasound, nuclear medici ne, MRI, CT, and fluoroscopy services. Screening and diagnostic mammogr ams are exempt. Since payment for these procedures is capped by statute we propos ed to exclude them from this policy.

● Codes with Low Volume in the OPPS or ASC : We proposed to exclude any service for which 5 percent or less of the total number of services are furnis hed in the OPPS setting

relative to the tota l number of PFS/OPPS allowed services.

● Codes with ASC Rates Based on PFS Payment Rates : To avoid issues of circularity, we proposed to exclude ASC services that are subject to the “office-based” procedure payment policies for which payment rate s are based on the PFS nonfacility PE RVUs. We directed

interested readers to the CY 2013 OPPS final rule (77 FR 68444) for additional information regarding this payment policy.

● Codes Paid in the Facili ty at Nonfacility PFS Rates : To avoid issues of circularity, we also proposed to exclude services that are paid in the facility setting at nonfacility payment rates.

### CMS-1600-FC 73

This would include certain profe ssional-only services where the resource costs for practitioners are assumed to be similar in both settings.

● Codes with PE RVUs Deve loped Outside the PE Methodology : We also proposed to

exclude services with PE RVUs established th rough notice and comment rulemaking outside the PE Methodology. Addendum B of the proposed rule displa yed the PE RVUs that would result from implementation of the proposed change in the PE methodology. In discussing resource input issues, some stak eholders have previous ly suggested that the direct costs (for example, clini cal labor, disposable supplies a nd medical equipment) involved in furnishing a service are similar in both the nonf acility and facility settings. Others have suggested that facilities, like hos pitals, have greater purchasing power for medical equipment and disposable supplies so that the direct costs for a facility to furnish a service can be lower than costs for a physician practice furnishing the same service. Our proposed policy did not assume

that the direct costs to furnish a service in th e nonfacility setting are al ways lower than in the facility setting. Medicare payment met hodologies, including both OPPS and the PFS PE methodology, incorporate both direct and indirect costs (administrative labor, office expenses, and all other expenses). Our proposed polic y was premised on the idea that there are significantly greater indirect resource costs that ar e carried by facilities even in the event that the direct costs involved in furnishing a service in th e office and facility settings are comparable.

We stated our belief that our proposal provides a reliable m eans for Medicare to set upper payment limits for office-based procedures base d on relatively more reli able cost information available for the same procedures when furnished in a facility setting wh ere the cost structure would be expected to be somewhat, if not si gnificantly, higher than the office setting. We

### CMS-1600-FC 74

believe that the current basis for estimating the resource costs involved in furnishing a PFS service is significantly encumbered by our curr ent inability to obtain accurate information regarding supply and equipment pr ices, as well as procedure time assumptions. We believe that our proposed policy would mitigate the negativ e impact of these difficulties on both the appropriate relativity of PFS services and ove rall Medicare spending. A wide range of stakeholders and public commenter s have pointed to the nonfacility setting as the most costeffective location for services. Given the signif icantly higher cost struct ure of facilities (as discussed above) we believe that this presum ption is accurate. In its March 2012 report to Congress, MedPAC recommended that Medicare s hould seek to pay similar amounts for similar services across payment settings, taking into account differences in the definitions of services and patient severity. (MedPAC March 2012 Report to Congress, page 46) We believe that the proposed change to our PFS PE methodology would mo re appropriately refl ect resource costs in the nonfacility setting.

Comment : One commenter representing primary care physicians supported the proposal and indicated a belief that the proposed polic y would help to correct misvaluation between primary care services and the services affected by the policy. Another commenter supported the policy as an interim step until an expedited review of the se rvices could be conducted. Other commenters, while not supporting the proposal due to the financial impact on certain services, stated that hospitals and ASCs do typically in cur higher overhead costs in delivering services than physician offices. The overwhelmingly majority of commenters objected to the proposed policy. Several commenters believed the services impacted by th e policy were potentially misvalued, but still opposed our policy. Many commenters questioned whether facilities’ costs for providing all

### CMS-1600-FC 75

services are necessarily higher th an the costs of physicians or other practitioners. Commenters stated that the resources required to furnish se rvices in nonfacility physician settings cannot be accurately measured using the OPPS methodology a nd that our proposal would result in rank

order anomalies. Commenters indicated that it was inappropriate to base PFS payment on OPPS payment since a single APC contains multiple serv ices that can involve a wide a range of costs that are averaged under the OPPS methodology. Ma ny commenters also stat ed that since OPPS payment rates rely on the accuracy of APC paym ents, developed through hospitals accurately allocating their costs and charges to particular de partments/APCs. These commenters stated that hospitals may have little incentive to accurately allocate their costs and charges to particular departments/APCs since they typical ly provide a broad range of serv ices and therefore have the ability to make up for losses on one service with profits on another. The argument is that this ability makes the precise pricing of individual services less importa nt in the OPPS system than it is in the physician set ting. Also, the argument is that if physicians are going to be paid based upon the OPPS system it should be for all services so that like the hospitals they benefit from those overpaid in the hospital. Many commenters also questio ned CMS’ authority to use payment rates from other Medicare payment met hodologies to cap PFS rates since they asserted the policy violated the statutor y requirement that the PFS PE re lative values be based on the resources used in furnishing the service. Some commenters also cited the financial impact of our proposed policy on the PFS rates as a furthe r reason that the policy was inappropriate. For all of these reasons, these commenters r ecommended that we not adopt the proposed policy. Many of these commenters also suggested modifications to the policy if CMS did decide to move forward. Commenters suggested that since the ASC rates reflect the OPPS relative weights to determine payment rates under the AS C payment system, and are not based on cost

### CMS-1600-FC 76

information collected from ASCs, the ASC rate s should not be used in the proposed policy. Commenters also stated a strong preference to use prospective year OPPS rates instead of current year OPPS rates as the point of comparis on to prospective year PFS rates. The CY 2014 OPPS proposed rule proposed significant packag ing that raised payment for many APCs, and therefore, raised the associated PFS cap rate.

Some commenters stated that they believed that CMS does not have authority to use any conversion factor in the policy other than th e one calculated under existing law for CY 2014.

Commenters stated that the low-volume th reshold (a minimum of 5 percent in the hospital outpatient setting) was pr oposed with insufficient rationale and recommended either a 50 percent threshold or an absolute volume thres hold. Commenters also ar gued that there should be an ASC low-volume threshold for using ASC rates. Commenters urged CMS to establish a means fo r stakeholders to dem onstrate the validity of office costs relative to OPPS payments prior to implementing a cap for any particular code. Commenters also suggested that the AMA RUC should examine each code prior to the implementation of the policy for that code. Commenters suggested excluding codes recen tly revalued, such as certain surgical pathology codes, from the cap as their resource i nputs and costs are more accurate than those less recently revalued. Commenters suggested that CM S should make the cap more transparent by identifying all affected codes and displaying the data us ed in establishing the capped values. Several commenters suggested using the in dividual OPPS HCPCS code costs that are used to calculate the APC payment, rather than the APC payment rate itself, as a way of avoiding the problems caused by the averaging that goe s on in calculating the APC rates. These

### CMS-1600-FC 77

commenters argued that i ndividual code costs are a more appropriate comparison than APC payment rates. Response : As we stated in the proposed rule, when services are furnished in the facility setting, such as an HOPD or ASC, the total Me dicare payment (made to the facility and the professional combined) typically exceeds the Medi care payment made for the same service when furnished in the physician office or other nonfacility setting. We continue to believe that this payment difference generally reflec ts the greater costs that facil ities incur compared to those incurred by practitioners furnishi ng services in offices and other non-facility settings. We also

continue to believe that if the total Medicare payment when a servi ce is furnished in the physician office setting exceeds the total Medicare payment when a service is furnished in an HOPD or an ASC, this is generally not the resu lt of appropriate paymen t differentials between

the services furnished in different settings. Rather, we continue to believe that it is primarily due

to anomalies in the data we use under the PFS and in the application of our resource-based PE methodology to the particular services. We greatly appreciate all of the comments th at we received on our proposal. Given the many thoughtful and detailed technical comments th at we received, we are not finalizing our proposed policy in this final rule with comment period. We will consider more fully all the comments received, including those suggesting technical improvements to our proposed methodology. After further consideration of the comments, we expect to develop a revised proposal for using OPPS and ASC rates in deve loping PE RVUs which we will propose through future notice and comment rulemaking. At this time, we do not believe that our standard process for evaluating potentially misvalued codes, including the use of the AMA RU C is an effective means of addressing these

### CMS-1600-FC 78

codes. As we stated in the proposed rule, we do not believe that the direct practice expense information we currently use to value these codes is accurate or reflects typical resource costs. We have addressed these issues extensively in previous rulemaking (f or example, 75 FR 73252) and again in section II.B.4. of this final rule with comment period. We believe the current review process for direct PE inputs only accommodates incomplete, small sample, and potentially biased or inaccurate resource input costs that may distort the resources used to develop nonfacility PE RVUs used in calculati ng PFS payment rates for individual services. 3. Ultrasound Equipment Recommendations In the CY 2012 PFS proposed rule (76 FR 42796), we asked the AMA RUC to review the ultrasound equipment described in the direct PE input database . We specifically asked for review of the ultrasound equipment items describe d in the direct PE input database and whether the ultrasound equipment listed for specific pr ocedure codes is clinically necessary. In response, the AMA RUC recommended cr eating several new equipment inputs in addition to the revision of current equipment i nputs for ultrasound services. The AMA RUC also forwarded pricing information for new and ex isting equipment items from certain medical specialty societies that represen t the practitioners who furnish th ese services. In the following paragraphs, we summarize the AMA RUC recommendations, addre ss our review of the provided information, and describe a series of changes we proposed to the direct PE inputs used in developing PE RVUs for th ese services for CY 2014. (1) Equipment Rooms

The AMA RUC made a series of recommendations regarding the ultrasound equipment

items included in direct PE input equipment packages called “rooms.” Specifically, the AMA RUC recommended adding several new equipment items to the equipment packages called

### CMS-1600-FC 79

“room, ultrasound, general” (EL015) and “room , ultrasound, vascular” (EL016). The AMA RUC also recommended creating a similar direct PE input equipment package called “room, ultrasound, cardiovascular.” In c onsidering these recommendations , we identified a series of new concerns regarding the makeup of these equi pment packages and becau se there are several different ways to handle these concerns. In the CY 2014 PFS proposed rule we sought public comment from stakeholders prior to proposing to implement any of these recommended changes through future rulemaking. We noted that the existing “rooms” for ultrasound technol ogy include a greater number

of individual items than the “rooms” for other ki nds of procedures. For example, the equipment package for the “room, basic radiology” (EL012) contains only two items: an x-ray machine and a camera. Ordinarily under the PFS, direct PE input packages for “rooms” include only equipment items that are typically used in fu rnishing every service in that room. When equipment items beyond those included in a “room” are typically us ed in furnishing a particular procedure, the additional equipment items for that procedure are separately reflected in the direct PE input database in addition to the “room” ra ther than being included in the room. When handled in this way, the room includes only t hose inputs that are comm on to all services furnished in that room type, and thus the direct PE inputs are a ppropriate for the typical case of each particular service. When additional equipment items are invol ved in furnishing a particular service, they are included as an individual PE input only for that particular service. In contrast, the equipment items currently in cluded in the “room, ultrasound, general” are: the ultrasound system, five diffe rent transducers, two probe star ter kits, two printers, a table, and various other items. In the proposed rule, we stated that we do not believe that it is likely that all of these items would be typically used in furnishing each servi ce. For example, we do

### CMS-1600-FC 80

not believe that the typical ultrasound study woul d require the use of fi ve different ultrasound transducers. However, the cost s of all of these item s are incorporated into the resource inputs for every service for which the ultrasound room is a direct PE input, regardless of whether each of those items is typically used in furnishing the particular servi ce. This increases the resource cost for every service that uses the room regardle ss of whether or not each of the individual items is typically used in furnishi ng a particular procedure. Instead of proposing to incorporate the AMA RUC’s recommendation to add more equipment items to these ultrasound equipment “r oom” packages, we stated our intention to continue to consider the appropr iateness of the full number of items in the ultrasound “rooms” in the context of maintaining appropr iate relativity with other serv ices across the PFS. We sought comment from stakeholders, including the AMA RUC, on the items included in the ultrasound rooms, especially as compared to the items includ ed in other equipment “rooms.” We stated that we thought that it would be appr opriate to consider these comments in future rulemaking instead of proposing to alter the existing “rooms” ju st for ultrasound equipment items for CY 2014. Specifically we sought comment on whether equipment packages called “rooms” should include all of the items that might be in cluded in an actual room, just the items typically used for every service in such a room, or all of the items typically used in typical services furnished in the room.

We stated that we believed th at it would be most appropriate to propose changes to the “room, ultrasound, general” (EL015) and “room, ultras ound, vascular” (EL016) in the context of considering comments on this broader issue. We al so stated that we believed that consideration of the broader issue will help determine whethe r it would be appropriate to create a “room, ultrasound, cardiovascular,” and if so, what items would be included in this equipment package.

Comment : Several commenters, including the AM A RUC, suggested that equipment

### CMS-1600-FC 81

room packages should include all items that are typically in the room and cannot be used for another patient, in order to furnish all typical se rvices performed in that room. In its comment letter, the AMA RUC urged CMS to adopt its pr evious recommendations and pointed out that CMS has previously stated that equipment time is comprised of any time that clinical labor is using the piece of equipment, plus any additiona l time the piece of equipment is not available for use with another patient due to its use during the procedure in question. Therefore, any time a piece of equipment is not available for use w ith another patient, th e equipment should be

allocated minutes. The AMA RUC also pointed out, as an example, that the equipment item called “otoscope-ophthalmoscope (wall unit)” (EQ189) is a standard equipment input for all E/M codes even though it may not be typically used fo r each E/M service. Therefore, items included in the room but not necessarily typically used in furnishing particular servi ces should be included as equipment minutes for all codes that typically use the room. Response : We appreciate the responses of th e AMA RUC and othe rs regarding our questions regarding equipment packages. We re main concerned about the appropriate estimate of resources regarding equipment items, especially those in room packages. We note that in our previous statements regarding allocation of equipment minutes, we have articulated that equipment minutes should be allocated to partic ular items when those items are unavailable for use with another patient “due to its use dur ing the procedure in question.” Based on the recommended equipment room packages, we are concerned that this definition may not apply consistently in the direct PE input database. While we understand the example of the “otoscopeophthalmoscope (wall unit)” (EQ189) for E/M serv ices, we believe that there may be othermedical equipment items in a typical evaluation room in addition to the otoscopeophthalmoscope (wall unit) and an exam table.

### CMS-1600-FC 82

These comments reinforce our belief that, for the sake of relativity and accuracy, changes to particular equipment room packages should be made in the context of a broader examination of all equipment packages, as well as assumed equipment utilization rates for these packages. In addition to the concerns regarding the c ontents of the ultras ound “room” packages, we also expressed concerned about the pricing information submitted through the AMA RUC to support its recommendation to add equipment to the ultrasound room packages. The highestprice item used in pricing th e existing equipment input called “room, ultrasound, general” (EL015), is a “GE Logic 9 ultrasound system,” currently priced at $220,0 00. As part of the

AMA RUC recommendation described in th e proposal, a medical specialty society recommended increasing the price of that item to $314,500. However, that recommendation did not include documentation to support the pricing leve l, such as a copy of a paid invoice for the equipment. Furthermore, the recommended pri ce conflicts with certain publicly available information. For example, th e Milwaukee Se ntinel-Journal reported in a February 9, 2013 article that the price for GE ultras ound equipment ranges from “$7,900 for a hand-held ultrasound to $200,000 for its most advanced model.” The same article points to an item called the “Logiq E9” as the ultrasound machine most used by radiologists and priced from $150,000 to $200,000. http://www.jsonline.com/busines s/ge-sees-strong-futur e-with-its-ultraso und-business-uj8mn79-

190533061.html In the proposed rule, we noted that we were unsure how to best reconcile the information disclosed by the manufacturer to the press a nd the prices submitted by the medical specialty society for use in updating the direct PE input pri ces. We believe discrepancies, such as these, exemplify the potential problem with updating pri ces for particular items based solely on price quotes or information other than copies of paid invoices. However, copies of paid invoices must

### CMS-1600-FC 83

also be evaluated carefully. The information pr esented in the article regarding the price for

hand-held ultrasound devices raises questions about the adequacy of paid invoices, too, in determining appropriate input co sts. The direct PE input de scribed in the database as “ultrasound unit, portable” (EQ250) is currentl y priced at $29,999 base d on a submitted invoice,

while the article cites that GE sells a portable unit for as lo w as $7,900. We sought comment on the appropriate price to use as the typical for po rtable ultrasound units.

Comment : We received several comments regarding the appropriate means to price the direct PE inputs. The AMA RUC and several speci alty expressed concern that it is difficult for medical specialty societies to obtain paid invoic es for equipment and supplies, especially for large equipment items that are bought infrequently. Several medical specialty societies suggested that their members are often uncomfortable sending invoices for expensive items since the prices are often propr ietary and even though identifying information is redacted, the invoi ces are sometimes distri buted to all AMA RUC meeting participants and available to the public once submitted to CMS. The specialty society suggested that certain stakeholders in the mark etplace are often able to identify the individual practice submitting the invoice through this proc ess and that such public revelation of the propriety pricing information may have major im plications for the provider in future price negotiations and service lines in local markets for any pr actitioner volunteering such

information. The AMA RUC expressed a shared concer n with CMS about pricing information submitted as supporting documentation for the ultras ound room packages and stated that it will work with medical specialty soci eties to provide paid invoices as soon as possible. The AMA RUC also noted that it will work with the specia lties to ensure that paid invoices, rather than

### CMS-1600-FC 84

quotes, are submitted to CMS. Several commen ters objected to CMS’ suggestion that a newspaper article might more accurately refl ect typical resource costs than an invoice. Response : We appreciate the response of the AMA RUC to these concerns. We also appreciate that in many cases the staff of medical specialty societies may have difficulty obtaining paid invoices. However, we believe th e difficulty in obtaining invoices due to market sensitivity does not negate or lessen the critical importance of using accurate pricing information in establishing direct PE inputs. We believe it is likely that the pricing information would be less

market sensitive if the information served to c onfirm the assumptions we already display in the direct PE input database. We appreciate the concerns shared by the AMA RUC’s and we

continue to seek the best mean s to identify typical resource co sts associated with disposable supplies and medical equipment. While we believe that a copy of a paid invoice is the minimal amount of necessary information for pricing a dis posable supply or medical equipment input, we reiterate our concerns that, ev en when proffered, a sole paid invoice is not necessarily the optimal source for identifying typical resource costs. We agree with commenters that information a manufacturer provides the news medi a is not necessarily accur ate. However, when

such information stands in stark c ontrast to single invoices, we be lieve it is imperative to attempt to reconcile that information to identify the best available information regarding the typical cost. We will continue to consider the perspectives offered by these commenters in developing future proposals regarding the pricing of indi vidual items and equipment packages. (2) New Equipment Inputs and Price Updates Ultrasound Unit, portable, breast procedures. The AMA RUC reco mmended that a new direct PE input, "ultrasound unit, portable, breast procedures," be created for breast procedures that are performed in a surgeon's office and wh ere ultrasound imaging is included in the code

### CMS-1600-FC 85

descriptor. These services are described by CPT codes 19105 (Ablat ion, cryosurgical, of fibroadenoma, including ultrasound guidance, each fibroadenoma), 19296 (Placement of radiotherapy afterloading expandable catheter (single or multichannel) into the breast for interstitial radioelement application following partial mastectomy, includes imaging guidance; on date separate from partial mastectomy), a nd 19298 (Placement of radiotherapy afterloading brachytherapy catheters (multiple tube and bu tton type) into the breast for interstitial radioelement application following (at the time of or subsequent to) pa rtial mastectomy, includes imaging guidance). As we noted in the proposed rule, we are creating th is input. The pricing information submitted for this item is a paid invoice and two price quotes. As we have previously stated, we believe that copies of paid invoices are more likely to reflect actual resource costs associated with equipment and supply items than quotes or other information. Therefore, we proposed a price of $33,930, which reflects the price displayed on the submitted copy of the paid invoice. We are not using the quotes as we do not beli eve that quotes provide reliable information about the prices that are ac tually paid for medical equipment. We did not receive any additional informati on regarding the price for this equipment item. Therefore the CY 2014 direct PE input database reflects the price as proposed. Endoscopic Ultrasound Processor. The AMA RUC recommende d creating a new direct PE input called “endoscopic ultras ound processor,” for use in furnishing the service described by CPT code 31620 (Endobronchial ultrasound (EBUS) during bronchoscopic diagnostic or therapeutic intervention(s) (List separately in ad dition to code for primary procedure[s])). We created this equipment item to use as an input in the direct PE input database. The price associated with the “endoscopic ultrasound pr ocessor” is $59,925, whic h reflects the price documented on the copy of the paid invoice subm itted with the recommendation. We did not

### CMS-1600-FC 86

receive any additional informati on regarding the price for this equipment item. Therefore the CY 2014 direct PE input database reflects the price as proposed. Bronchofibervideoscope. The AMA RUC recommended cr eating a new direct PE input called “Bronchofibervideoscope,” for use in fu rnishing the service described by CPT code 31620 (Endobronchial ultrasound (EBU S) during bronchoscopic diagnostic or therapeutic intervention(s) (List separately in addition to co de for primary procedure[s])). We created this new equipment item to use as an input in the di rect PE input database. However, this item had no price associated with it in th e proposed direct PE input data base because we did not receive any information that would allow us to pri ce the item accurately. Consequently, we sought copies of paid invoices for this equipment item in the CY 2014 proposed rule so that we could price the item accurately in the future.

Comment: One commenter reported that the current sales price for the bronchofibervideoscope ranges from $30,000 - $50,000. The commenter provided an invoice for the equipment that reflected a price of $35,200. Response: Based on the submission of the invo ice information, we have updated the direct PE input database to reflect a price of $35,200 for the Bronchofibervideoscope (ER093). Endoscope, ultrasound probe, drive (ES015) . The AMA RUC forwarded pricing information to us regarding the existing i nput called “endoscope, ultrasound probe, drive” (ES015), including a copy of a paid invoice. Ba sed on this information, we proposed to change the price associated with ES015 to $13,256.25, wh ich reflects the price documented on the submitted copy of the paid invoice. We did not receive any additional information regarding the price for this equipment item. Therefore, we the CY 2014 direct PE input database reflects the price as proposed.

### CMS-1600-FC 87

(2) Ultrasound Equipment Input Recomm endations for Particular Services The AMA RUC made recommendations regardin g the typical ultrasound items used in furnishing particular services. In genera l, the AMA RUC recommended that the existing equipment items accurately described the typical equipment used in furnishing particular services. However, for some CPT codes th e AMA RUC recommended changing the associated equipment inputs that appear in the direct PE input database. Based on our review of these recommendations, we generally agreed with the AMA RUC regarding these recommended changes, and the recommended changes are reflected in the direct PE in put database. Table 10 displays the codes with changes to ultrasound equi pment. However, for certain codes we did not agree with the recommendations of the AMA RUC. The following paragraphs address the changes we proposed that differ from the recommendations of the AMA RUC.

For a series of cardiovascul ar services that include ul trasound technology, the AMA RUC recommended removing certain equipment items and replacing those items with a new item called “room, ultrasound, cardiovascu lar.” As we described in th e preceding paragraphs, we did not propose to create the “room, ultrasound, cardiovascular” and ther efore did not propose to add this “room” as an input for these services. However, we noted that the newly recommended equipment package incorporates many of the sa me kinds of items as the currently existing “room, ultrasound, vascular” (EL016). We agreed with the AMA RUC’s suggestion that the existing equipment inputs for the relevant serv ices listed in Table 10 do not reflect typical resource costs of furnishing the services. We believed that, pending our fu rther consideration of the ultrasound “room” equipment packages, it woul d be appropriate to use the existing “room, ultrasound, vascular” (EL016) as a proxy fo r resource costs for these services.

Comment: Several commenters urged CMS to accept the AMA RUC’s

### CMS-1600-FC 88

recommendations. Most of these commenters sugge sted that if CMS were not to accept the

AMA RUC’s recommendation to create the ne w “cardiovascular ultrasound room” for CY 2014, then the inputs for the existing “room, ultras ound, vascular” (EL016) sh ould be used. A few commenters representing some of the practitioners who furnish some of these services objected to the change in equipment inputs based on thei r assertion that the members of their specialty societies typically use more resource intens ive equipment than reflected in the AMA RUC

recommendations. One of these commenters suggested that the CPT codes for fetal echocardiography (CPT codes 76825, 76826, 78627, and 78628) previously included the same equipment items as the other echocardiography c odes with equipment updates. This commenter suggested that the equipment for these code s should be updated to correspond with the equipment for other, similar services. Response: As we noted in the proposed rule, we believe that the issue of equipment room packages should be addressed in future rulemaking. Based on these comments, we are finalizing the use of the existing “room, ultras ound, vascular” (EL016) as a proxy for resource costs for these services pending future considera tion of equipment room packages. We note that

the AMA RUC based its recommendation on inform ation obtained from the medical specialty societies that represent the speci alty of the practitioners who fu rnish the majority of allowed services for each of these codes using recent Medi care claims data. We examined the comments we received objecting to the finalizati on of the AMA RUC-recommended equipment recommendations and, in each case, confirmed that the commenters did not represent the practitioners who typically furnis h each service according to the Medicare claims data. In the case of the fetal echocardiography codes, we ag ree with the commenter’s suggestion that the equipment for these codes should correspond with the equipment for the similar services,

### CMS-1600-FC 89

especially since the AMA RUC recommended repl acing these items for all other codes in the direct PE inputs database. Ba sed on that review, we remain confident that our proposal is appropriate and we are finalizi ng the changes in the ultrasound equipment items as proposed, with the exception of updating the equipment items for fetal ec hocardiography to be consistent with other echocardiography services. These cha nges are displayed in Ta ble 10 and incorporated in the CY 2014 direct PE input database. In the case of CPT code 76942 (Ultrasonic guid ance for needle placement (for example, biopsy, aspiration, injection, localization device), imaging supervision and interpretation), we agreed with the AMA RUC’s recommendation to replace the current equipment input of the “room, ultrasound, general” (EL015) with “ultra sound unit, portable” (E Q250). We note that this service is typically reported with other code s that describe the need le placement procedures and that the recommended change in equipment from a room to a portable device reflects a change in the typical kinds of pr ocedures reported with this imag e guidance service. Given this change, we believe that it is a ppropriate to reconsider the proc edure time assumption currently used in establishing the direct PE inputs for this code, which is 45 minutes. We reviewed the services reported with CPT code 76942 to identif y the most common procedures furnished with this image guidance. The code most fre quently reported with CPT code 76942 is CPT 20610 (Arthrocentesis, aspiration and/or injection; major joint or bursa (for example, shoulder, hip, knee joint, subacromial bursa). The assumed pro cedure time for this service is five minutes. The procedure time assumptions for the vast majo rity of other procedures frequently reported with CPT code 76942 range from 5 to 20 minutes . Therefore, in addition to proposing the recommended change in equipment inputs associat ed with the code, we proposed to change the procedure time assumption used in establishing di rect PE inputs for the service from 45 to 10

### CMS-1600-FC 90

minutes, based on our analysis of 30 needle placeme nt procedures most frequently reported with

CPT code 76942. We noted that this reduced the clinical labor and equipment minutes

associated with the code from 58 to 23 minutes.

Comment: Several commenters noted that the AMA RUC is planning to conduct surveys and review the assumptions regarding the code a nd that CMS will be in a better position to make

more accurate determinations if it waits for that data from the AMA RUC. One commenter stated that CMS should not make a change in th e direct PE input databa se based on information in the Medicare claims data without input from the medical specialty societies whose members furnish and report the ultrasound guidance as described with CPT code 76942 and that a recommendation from the AMA RUC may provide bett er data than the information contained on

Medicare claims. Response: We appreciate the partnership of the AMA RUC in the misvalued code initiative, but as a general pr inciple, we do not believe that we should refrain from making appropriate changes to code values solely becau se the AMA RUC is planning to review a service in the future. In some cases, we believe that we should examine claims information and other sources of data and make proposals regarding th e appropriate inputs used to develop the amount Medicare pays for PFS services. We believe th at notice and comment rulemaking itself provides a means for the public, including medical special ty societies and the AMA RUC, to respond substantively to proposed changes in resource in puts for particular services. Furthermore, in cases like this one, we do not beli eve that the information reflected in the Medicare claims data is subjective or open to differing interpretations.

Comment: Several commenters, including the AM A RUC, pointed out that CPT code 76942 includes supervision and interpretation, whic h represents both time and work that is

### CMS-1600-FC 91

separate from the surgical code and that the additional time incl uded in the direct PE inputs may reflect time in addition to the base procedure. Response: We appreciate the response of th e AMA RUC and others in pointing out concerns with our assumptions. We note that the proposed clinical la bor service period of 23

minutes includes the 10 minutes of intra-service time in addition to 2 minutes for preparing the room, equipment, and supplies, 3 minutes for preparing and positioning the patient, 3 minutes for cleaning the room, and 5 minutes for processing images, completing data sheet, and presenting images and data to the interpreting physician. We did not receive information from any commenters suggesting that the time allocated for th ese tasks was inadequate. Therefore, we are finalizing our adjustment to the clinical labor mi nutes associated with th is code, as proposed. TABLE 10: Codes with Changes to Ultrasound Equipment for CY 2014

CPT Code Descriptor CY 2013 CMS Equipment Code CY 2013 Equipment Description CY 2014 Equipment CMS Code CY 2014 Equipment Description

19105 Cryosurg ablate fa each EQ250 ultrasound unit, portable NEW ultrasound unit, portable, breast procedures

19296 Place po breast cath for rad EL015 room, ultrasound, general NEW ultrasound unit, portable, breast procedures

19298 Place breast rad tube/caths EL015 room, ultrasound, general NEW ultrasound unit, portable, breast procedures n/a NEW Bronchofibervideoscope 31620 Endobronchial us add-on n/a NEW Endoscopic ultrasound processor

52649 Prostate laser enucleation EQ255 ultrasound, noninvasive bladder scanner w-cart EQ250 ultrasound unit, portable

76376 3d render w/o postprocess EL015 room, ultrasound, general Remove input

76775 Us exam abdo back wall lim EL015 room, ultrasound, general EQ250 ultrasound unit, portable

76820 Umbilical artery echo EQ249 ultrasound color doppler, transducers

and vaginal probe EL015 room, ultrasound, general

### CMS-1600-FC 92

CPT Code Descriptor CY 2013 CMS Equipment Code CY 2013 Equipment Description CY 2014 Equipment CMS Code CY 2014 Equipment Description

EQ254 ultrasound, echocardiography w-4 transducers (Sequoia C256) 76825 Echo exam of fetal heart EQ252 ultrasound, echocardiography analyzer software (ProSolv) EL016 room, ultrasound, vascular

EQ254 ultrasound, echocardiography w-4 transducers (Sequoia C256) 76826 Echo exam of fetal heart EQ252 ultrasound, echocardiography analyzer software (ProSolv) EL016 room, ultrasound, vascular

76827 Echo exam of fetal heart EQ254 ultrasound, echocardiography w-4 transducers (Sequoia C256) EL016 room, ultrasound, vascular

76828 Echo exam of fetal heart EQ254 ultrasound, echocardiography w-4 transducers (Sequoia C256) EL016 room, ultrasound, vascular

76857 Us exam pelvic limited EL015 room, ultrasound, general EQ250 ultrasound unit, portable

76870 Us exam scrotum EL015 room, ultrasound, general EQ250 ultrasound unit, portable

76872 Us transrectal EL015 room, ultrasound, general EQ250 ultrasound unit, portable

76942 Echo guide for biopsy EL015 room, ultrasound, general EQ250 ultrasound unit, portable

EQ253 ultrasound, echocardiography digital acquisition (Novo Microsonics, TomTec) 93303 Echo guide for biopsy

EQ254 ultrasound, echocardiography w-4 transducers (Sequoia C256) EL016 room, ultrasound, vascular

### CMS-1600-FC 93

CPT Code Descriptor CY 2013 CMS Equipment Code CY 2013 Equipment Description CY 2014 Equipment CMS Code CY 2014 Equipment Description

EQ252 ultrasound, echocardiography analyzer software (ProSolv)

EQ252 ultrasound, echocardiography analyzer software (ProSolv)

EQ253 ultrasound, echocardiography digital acquisition (Novo Microsonics, TomTec) 93304 Echo transthoracic

EQ254 ultrasound, echocardiography w-4 transducers (Sequoia C256) EL016 room, ultrasound, vascular

EQ253 ultrasound, echocardiography digital acquisition (Novo Microsonics, TomTec)

EQ254 ultrasound, echocardiography w-4 transducers (Sequoia C256) 93306 Tte w/doppler complete

EQ252 ultrasound, echocardiography analyzer software (ProSolv) EL016 room, ultrasound, vascular

EQ252 ultrasound, echocardiography analyzer software (ProSolv)

EQ253 ultrasound, echocardiography digital acquisition (Novo Microsonics, TomTec) 93307 Tte w/o doppler complete

EQ254 ultrasound, echocardiography w-4 transducers (Sequoia C256) EL016 room, ultrasound, vascular

93308 Tte f-up or lmtd EQ252 ultrasound, echocardiography analyzer software (ProSolv) EL016 room, ultrasound, vascular

### CMS-1600-FC 94

CPT Code Descriptor CY 2013 CMS Equipment Code CY 2013 Equipment Description CY 2014 Equipment CMS Code CY 2014 Equipment Description

EQ253 ultrasound, echocardiography digital acquisition (Novo Microsonics, TomTec)

EQ254 ultrasound, echocardiography w-4 transducers (Sequoia C256)

EQ253 ultrasound, echocardiography digital acquisition (Novo Microsonics, TomTec)

EQ252 ultrasound, echocardiography analyzer software (ProSolv) EQ256 ultrasound, transducer (TEE Omniplane II) 93312 Echo transesophageal

EQ254 ultrasound, echocardiography w-4 transducers (Sequoia C256) EL016 room, ultrasound, vascular

EQ254 ultrasound, echocardiography w-4 transducers (Sequoia C256) EQ256 ultrasound, transducer (TEE Omniplane II)

EQ252 ultrasound, echocardiography analyzer software (ProSolv) 93314 Echo transesophageal

EQ253 ultrasound, echocardiography digital acquisition (Novo Microsonics, TomTec) EL016 room, ultrasound, vascular

EQ252 ultrasound, echocardiography analyzer software (ProSolv) 93320 Doppler echo exam heart

EQ253 ultrasound, echocardiography digital acquisition (Novo Microsonics, TomTec) EL016 room, ultrasound, vascular

### CMS-1600-FC 95

CPT Code Descriptor CY 2013 CMS Equipment Code CY 2013 Equipment Description CY 2014 Equipment CMS Code CY 2014 Equipment Description

EQ254 ultrasound, echocardiography w-4 transducers (Sequoia C256)

EQ252 ultrasound, echocardiography analyzer software (ProSolv) 93321 Doppler echo exam heart EQ254 ultrasound, echocardiography w-4 transducers (Sequoia C256) EL016 room, ultrasound, vascular

EQ252 ultrasound, echocardiography analyzer software (ProSolv)

EQ253 ultrasound, echocardiography digital acquisition (Novo Microsonics, TomTec) 93325 Doppler color flow add-on

EQ254 ultrasound, echocardiography w-4 transducers (Sequoia C256) EL016 room, ultrasound, vascular

EQ252 ultrasound, echocardiography analyzer software (ProSolv)

EQ253 ultrasound, echocardiography digital acquisition (Novo Microsonics, TomTec) 93350 Stress tte only

EQ254 ultrasound, echocardiography w-4 transducers (Sequoia C256) EL016 room, ultrasound, vascular

93351 Stress tte complete EQ254 ultrasound, echocardiography w-4 transducers (Sequoia C256) EL016 room, ultrasound, vascular

93980 Penile vascular study EL015 room, ultrasound, general EQ249 ultrasound color doppler, transducers and vaginal probe

93981 Penile vascular study EL015 room, ultrasound, general EQ249 ultrasound color doppler, transducers and vaginal probe

### CMS-1600-FC 96

B. Misvalued Services 1. Valuing Services Under the PFS Section 1848(c) of the Act requires the Secretar y to determine relative values for physicians’ services based on three components: work, PE, and malpractice. Section 1848(c)(1)(A) of the Act defines the work component to include “the portion of the resources used in furnishing the service that reflects physician time and intensity in furnishing the service.” In addition, section 1848(c)(2)(C)(i) of the Act specifies that “the Secretary shall determine a number of work relative value units (RVUs) for the service based on the relative resources incorporating phy sician time and intensity required in furnishing the service.” Section 1848(c)(1)(B) of the Act defi nes the PE component as “the portion of the resources used in furnishing the service that reflects the gene ral categories of expenses (such as office rent and wages of personnel, but excluding malpractice expen ses) comprising practice expenses.” (See section I.B.1.b. for more detail on the development of th e PE component.) Section 1848(c)(1)(C) of the Act defines the malpractice component as “the portion of the resources used in furnishing the service that reflects malpractice expenses in furnishing the service. ” Sections 1848 (c)(2)(C)(ii) and (iii) of the Act specify that PE and malpractice RVUs shall be dete rmined based on the relative PE/malpractice resources involved in furnishing the service. Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a periodic review, not less often than every 5 years, of the RVUs established under th e PFS. Section 3134(a) of the Affordable Care Act added a new section 1848(c)(2)(K) to the Act, which requires the Secretary to periodically identify potentially misvalued services using certain criteria and to review and make appropriate adjustments to the relative values for those services. Section 3134( a) of the Affordable Care Act also added a new section 1848(c)(2)(L) to the Act, which requires the Secretary to develop a process to validate the RVUs of certain potentially misvalued codes under the PFS, identified using the same criteria used to identify potentially misvalued codes, and to make appropriate adjustments.

As discussed in section II.B.1. of this final rule with comment period, each year we develop and propose appropriate adjustments to the RVUs, taking into account the recommendations provided by the

### CMS-1600-FC 97

American Medical Association/Specialty Society Relative Value Scale Update Committee (AMA RUC), the Medicare Payment Advisory Commission (MedPAC) , and others. For many years, the AMA RUC has provided us with recommendations on the appropri ate relative values for new, revised, and potentially

misvalued PFS services. We review these recommendati ons on a code-by-code basis and consider these recommendations in conjunction with analyses of other data, such as claims data, to inform the decisionmaking process as authorized by the law. We may also consider analyses of physician time, work RVUs, or direct PE inputs using other data sources, such as Department of Veteran Affairs (VA), National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS) National Database, and the Physician Quality Reporting System (PQRS) databases. In addition to considering the most recently available data, we also assess the results of physician surveys and specialty recommendations submitted to us by the AMA RUC. We conduct a clinical review to assess the appropriate RVUs in the context of contempor ary medical practice. We note that section 1848(c)(2)(A)(ii) of the Act authorizes the use of ex trapolation and other techniques to determine the RVUs for physicians’ services for which specific data are not available in addition to taking into account the results of consultations with organizations representing physicians. In accordance with section 1848(c) of the Act, we determine appropriate adju stments to the RVUs, explain the basis of these adjustments, and respond to public comment s in the PFS proposed and final rules. 2. Identifying, Reviewing, and Validating the RVUs of Po tentially Misvalued Services a. Background In its March 2006 Report to the Congress, MedPAC noted that “misvalued services can distort the price signals for physicians’ services as well as for other health care services that physicians order, such as hospital services.” In that same report MedPAC postulated that physicians' services under the PFS can become misvalued over time. MedPAC stated, “w hen a new service is added to the physician fee schedule, it may be assigned a relatively high value b ecause of the time, technical skill, and psychological stress that are often required to furnish that service. Over time, the work required for certain services would be expected to decline as physicians become mo re familiar with the service and more efficient in

### CMS-1600-FC 98

furnishing it.” We believe services can also become overvalued when PEs decline. This can happen when the costs of equipment and supplies fall, or when equipment is used more frequently than is estimated in the PE methodology, reducing its cost per use. Likewise, services can become undervalued when physician work increases or PEs rise. In the ensuing years since MedPAC’s 2006 report, additional groups of potentially misvalued services have been identified by the Congress, CMS, MedPAC, the AMA RUC, and other stakeholders. In recent years, CMS and the AMA RUC have ta ken increasingly significant steps to identify and address potentially misvalued codes. As MedPAC not ed in its March 2009 Report to Congress, in the intervening years since MedPAC made the initia l recommendations, “CMS and the AMA RUC have taken several steps to improve the review process.” Most recently, section 1848(c)(2)(K)(ii) of the Act (as added by section 3134(a) of the Affordable Care Ac t) directed the Secretary to specifically examine, as determined appropriate, potentially misvalue d services in the following seven categories:

● Codes and families of codes for whic h there has been the fastest growth;

● Codes and families of codes that have experienced substantial changes in PEs;

● Codes that are recently established for new technologies or services;

● Multiple codes that are frequently billed in conjunction with furnishing a single service;

● Codes with low relative values, particularly those that are often billed multiple times for a single treatment;

● Codes which have not been subject to review since the implementation of the RBRVS (the socalled ‘Harvard-valued codes’); and

● Other codes determined to be appropriate by the Secretary. Section 1848(c)(2)(K)(iii) of the Act also specifi es that the Secretary ma y use existing processes

to receive recommendations on the revi ew and appropriate adjustment of potentially misvalued services. In addition, the Secretary may conduct surveys, other data collection activities, studies, or other analyses, as the Secretary determines to be appropriate, to facilitate the review and appropriate adjustment of potentially misvalued services. This section also author izes the use of analytic contractors to identify and

### CMS-1600-FC 99

analyze potentially misvalued codes, conduct surveys or collect data, and make recommendations on the review and appropriate adjustment of potentially mi svalued services. Additionally, this section provides that the Secretary may coordinate the review and adjustment of any RVU with the periodic review described in section 1848(c)(2)(B) of the Act. Fi nally, section 1848(c)(2)(K)(iii)(V) of the Act specifies that the Secretary may make appropriate coding revisions (including us ing existing processes for consideration of coding changes) that may include consolidation of individual services into bundled codes for payment under the physician fee schedule. b. Progress in Identifying and Revi ewing Potentially Misvalued Codes To fulfill our statutory mandate, we have iden tified and reviewed numerous potentially misvalued codes in all seven of the categories specified in sec tion 1848(c)(2)(K)(ii) of the Act, and we plan to continue our work examining potentially misvalued codes in these areas over the upcoming years. In the current process, we identify potentially misvalued codes for review, and request recommendations from the AMA RUC and other public commenters on revised wo rk RVUs and direct PE inputs for those codes. The AMA RUC, through its own processes, also iden tifies potentially misvalued codes for review. Through our public nomination process for potentiall y misvalued codes established in the CY 2012 PFS final rule with comment period, other individuals and stakeholder groups subm it nominations for review of potentially misvalued codes as well. Since CY 2009, as a part of the annual potentiall y misvalued code review and Five-Year Review process, we have reviewed more than 1,000 potentiall y misvalued codes to refine work RVUs and direct PE inputs. We have adopted appropriate work RVUs and direct PE inputs for these services as a result of

these reviews. A more detailed discussion of the exte nsive prior reviews of potentially misvalued codes

is included in the CY 2012 PFS final rule with comme nt period (76 FR 73052 thr ough 73055). In the CY 2012 PFS proposed rule, we proposed to identify and review potentially misvalued codes in the category of “Other codes determined to be appropriate by the Secretary,'' referring to a list of the highest PFS expenditure services, by specialty, that had not b een recently reviewed (76 FR 73059 through 73068).

### CMS-1600-FC 100

In the CY 2012 final rule with comment period, we finalized our policy to consolidate the review of physician work and PE at the same time (76 FR 73055 through 73958), and established a process for the annual public nomination of potentially misvalued services. One of the priority categories for review of poten tially misvalued codes is services that have not been subject to review since the implementation of the PFS (the so-called “Harvard-valued codes”). In the CY 2009 PFS proposed rule, we requested that th e AMA RUC engage in an ongoing effort to review the remaining Harvard-valued codes, focusing firs t on the high-volume, low intensity codes (73 FR 38589). For the Fourth Five-Year Review (76 FR 32410), we requested that the AMA RUC review services that have not been reviewed since the origin al implementation of the PFS with annual utilization greater than 30,000 (Harvard-valued—Utilization > 30 ,000). In the CY 2013 final rule with comment period, we identified for review the potentially misv alued codes for Harvard-valued services with annual allowed charges that total at least $10, 000,000 (Harvard-valued—Allowed charges ≥ $10,000,000). In addition to the Harvard-valued codes, in th e same rule we finalized for review a list of potentially misvalued codes that have stand-alone PE (these are codes with clinical labor procedure time assumptions not connected or dependent on physici an time assumptions; see 77 FR 68918 for detailed information). c. Validating RVUs of Potentially Misvalued Codes In addition to identifying and reviewing potentially misvalued codes, section 3134(a) of the Affordable Care Act added section 1848(c)(2)(L) of th e Act, which specifies th at the Secretary shall establish a formal process to validate RVUs unde r the PFS. The validation process may include validation of work elements (such as time, mental effort and professional judgment, technical skill and physical effort, and stress due to risk) involved w ith furnishing a service and may include validation of the pre-, post-, and intra-service components of work. Th e Secretary is directed, as part of the validation, to validate a sampling of the work RVUs of codes identified through any of the seven categories of potentially misvalued codes specified by section 1848(c)(2 )(K)(ii) of the Act. Furthermore, the Secretary may conduct the validation using methods similar to those used to review potentially misvalued codes,

### CMS-1600-FC 101

including conducting surveys, other data collection activities, studies, or other analyses as the Secretary determines to be appropriate to facilita te the validation of RVUs of services. In the CY 2011 PFS proposed rule (75 FR 4006 8) and CY 2012 PFS proposed rule (76 FR 42790), we solicited public comments on possible appro aches, methodologies, and data sources that we should consider for a validation process. A summary of the comments along with our responses are

included in the CY 2011 PFS final rule with comme nt period (75 FR 73217) and the CY 2012 PFS final rule with comment period (73054 through 73055). As we indicated in the CY 2014 PFS proposed rule (78 FR 43304), we have entered into two contracts with outside entities to develop validatio n models for RVUs. During a 2-year project, the RAND Corporation will use available data to build a validation model to predict work RVUs and the individual components of work RVUs, time and intens ity. The model design will be informed by the statistical methodologies and approach used to develo p the initial work RVUs and to identify potentially misvalued procedures under current CMS and AMA RUC processes. RAND will use a representative set of CMS-provided codes to test the model. RAND w ill consult with a technical expert panel on model design issues and the test results.

The second contract is with the Urban Institute. Given the central role of time in establishing

work RVUs and the concerns that have been raised about the current time values, a key focus of the project is collecting data from several practices for sel ected services. The data will be used to develop time estimates. Urban Institute will use a variety of approaches to develop objective time estimates, depending on the type of service, which will be a very resource-intensive part of the project. Objective time estimates will be compared to the current time valu es used in the fee schedule. The project team will then convene groups of physicians from a range of specialties to review the new time data and their potential implications for work and the ratio of work to time. The research being performed under these two contr acts continues. For additional information, please visit our website ( http://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/Downl oads/RVUs-Validation-Model.pdf ).

### CMS-1600-FC 102

3. CY 2014 Identification and Review of Potentially Misvalued Services a. Public Nomination of Potentially Misvalued Codes The public and stakeholders may nominate poten tially misvalued codes for review by submitting the code with supporting documentation during the 60-day public comment period following the release of the annual PFS final rule with comment period und er a process we finalized in the CY 2012 PFS final rule with comment period (76 FR 73058). Supportin g documentation for codes nominated for the annual review of potentially misvalued codes may include the following:

● Documentation in the peer-reviewed medical lite rature or other reliable data that there have been changes in physician work due to one or more of the following: technique; knowledge and technology; patient population; site-of-service; length of hospital stay; and physician time.

● An anomalous relationship between the code being proposed for review and other codes.

● Evidence that technology has changed physician work, that is, diffusion of technology.

● Analysis of other data on time and effort measures, such as operating room logs or national and other representative databases.

● Evidence that incorrect assumptions were made in the previous valuation of the service, such as a misleading vignette, survey, or flawed cro sswalk assumptions in a previous evaluation.

● Prices for certain high cost supplies or other direct PE inputs that are used to determine PE

RVUs are inaccurate and do not reflect current information.

● Analyses of physician time, work RVU, or direct PE inputs using other data sources (for example, Department of Veteran Affairs (VA) Nati onal Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS) National Data base, and the Physician Quality Reporting System (PQRS) databases).

● National surveys of physician time and intens ity from professional and management societies and organizations, such as hospital associations. After we receive the nominated codes during the 60-day comment period following the release of the annual PFS final rule with comment period, we evaluate the supporting documentation and assess

### CMS-1600-FC 103

whether the nominated codes appear to be potentiall y misvalued codes appropriate for review under the annual process. In the following year’s PFS propo sed rule, we publish the list of nominated codes and indicate whether we are proposing each nominated code as a potentially misvalued code. We encourage the public to submit nominations for potentially misv alued codes during the comment period for this CY 2014 PFS final rule with comment period. We did not receive any public nominations of codes for consideration as potentially misvalued codes in response to the CY 2013 final rule with co mment period. As a result, we did not propose any publicly nominated potentially misvalued codes in the CY 2014 proposed rule. b. Potentially Misvalued Codes i. Contractor Medical Director Identified Potentially Misvalued Codes We began considering additiona l ways to broaden participation in the process of identifying potentially misvalued codes; we solicited the input of Medicare Administrative Contractor medical directors (CMDs) in making suggestions for codes to consider proposing as potentially misvalued codes. In the proposed rule, we noted several reas ons why we believed that CMD input would be valuable in developing our proposal. As a group, CMDs represent a variety of medical specialties, which makes them a diverse group of physicians capable of providing opinions across the vast scope of services covered under the PFS. They are on the front line of administering the Medicare program, with their offices often serving as the first point of contact fo r practitioners with questi ons regarding coverage, coding and claims processing. CMDs spend a signi ficant amount of time communicating directly with practitioners and the health care industry discussing mo re than just the broad aspects of the Medicare program but also engaging in and facilitating sp ecific discussions around individual services. Through their development of evidence-based local coverage determinations (LCDs), CMDs also have experience developing policy based on research.

Comment : Many commenters supported our seeking input from the CMDs in developing our proposal for codes to be considered as potentially mi svalued codes, while others expressed concern about using input from CMDs. Some asked for details on the process that the CMDs used to identify codes and

### CMS-1600-FC 104

some questioned whether CMDs possess the specialty -related expertise to determine if a service is misvalued when that service is not generally perform ed by a CMD’s designated specialty. In addition,

several commenters believe that the identification of misvalued codes (in addition to review and revision of those codes) should be carried out through the AMA RUC process with input from the medical community. These commenters oppose any effort by CMS to unilaterally change code values. Response : The commenters are correct in noting that CMDs do not represent all specialties. We would note that in their role as CMDs, they do work on issues involving all speci alties. Moreover, their role in this process was simply to assist us in identifying codes that we could consider proposing as potentially misvalued codes. After our evaluation, we proposed them as potentially misvalued codes in the CY 2014 proposed rule and sought public comme nt. Thus the affected specialties and other stakeholders had the opportunity to provide us with public comment s as to whether or not these codes should be evaluated as potentially misvalued. If, fo llowing our consideration of public comments, we determine that these codes are potentially misvalue d, the AMA RUC and others will have further opportunity to submit information and public comment a bout the appropriate value of the codes before we

would determine the codes are in fact mi svalued and make changes to the values. Given the importance of ensuring that codes are a ppropriately valued, we be lieve it is appropriate to call upon the experience of CMDs in developing our proposal. A ccordingly, we will proceed as we proposed in the CY 2014 proposed rule to consider the codes identified by CMDs as potentially

misvalued codes. In consultation with our CMDs, the following lists of codes in Tables 11 and 12 were identified as potentially misvalued in the CY 2014 proposed rule. TABLE 11: Codes Proposed as Potentially Misval ued Identified in Consultation with CMDs CPT Code Short Descriptor 17311 Mohs 1 stage h/n/hf/g 17313 Mohs 1 stage t/a/l 21800 Treatment of rib fracture 22305 Closed tx spine process fx

### CMS-1600-FC 105

CPT Code Short Descriptor 27193 Treat pelvic ring fracture 33960 External circulation assist 33961 External circulation assist, each subsequent day 47560 Laparoscopy w/cholangio 47562 Laparoscopic cholecystectomy 47563 Laparo cholecystectomy/graph 55845 Extensive prostate surgery 55866 Laparo radical prostatectomy 64566 Neuroeltrd stim post tibial 76942 Echo guide for biopsy

CPT codes 17311 (Mohs micrographic technique, incl uding removal of all gross tumor, surgical excision of tissue specimens, mapping, color coding of specimens, microscopic examination of specimens by the surgeon, and histopathologic preparation including routine stain(s) (for example, hematoxylin and eosin, toluidine blue), head, neck, hands, feet genitalia, or any location with surgery directly involving muscle, cartilage, bone, tendon, major nerves, or v essels; first stage, up to 5 tissue blocks) and 17313 (Mohs micrographic technique, including removal of all gross tumor, surgical excision of tissue specimens, mapping, color coding of specimens, micro scopic examination of specimens by the surgeon, and histpathologic preparation including routine stains (s) (for example, hematoxylin and eosin, toluidine blue), of the trunk, arms, or legs; first stage, up to 5 tissue blocks) were proposed as potentially misvalued codes because we believe that these codes may be overvalued based on CMD comments suggesting

excessive utilization.

Comment : All commenting on CPT codes 17311 and 17313 stated that these codes were being reviewed by the AMA RUC in 2013, and two s uggested that we accept the AMA RUC recommended work values (6.2 and 5.56 respectiv ely) in the 2014 PFS final rule with comment period. One commenter

asserted that these codes were not misvalued and sh ould be removed from consideration as potentially misvalued but did not supply any information to support this view. Response : The commenters are correct that the c odes were under review by the AMA RUC. Since the publication of the proposed rule, we ha ve received recommendations from the AMA RUC for

### CMS-1600-FC 106

these codes. Rather than finalizing them as potentia lly misvalued codes, since we have the AMA RUC recommendations we are proposing interim final values for these codes per our usual process. (See section II.E.3.a.i.) These values are open for comment during the comment period for this final rule. CPT codes 21800 (Closed treatment of rib fracture, uncomplicated, each), 22305 (Closed treatment of vertebral process fracture(s)) and 27 193 (Closed treatment of pelvic ring fracture, dislocation, diastasis or subluxation, without mani pulation) were proposed for review as potentially

misvalued codes.

Comment : We received no comments on these codes. Response : We are finalizing our proposal to revi ew these codes as potentially misvalued codes. CPT codes 33960 (Prolonged extracorporeal circul ation for cardiopulmonary insufficiency; initial day) and 33961 (Prolonged extracorporeal circulation for cardiopulmonary insufficiency; each subsequent day) were proposed for review because the service wa s originally valued when it was used primarily in premature neonates; but the service is now being furn ished to adults with severe influenza, pneumonia and respiratory distress syndrome. We also noted in the proposed rule that, while the code currently includes 523 minutes of total physician time with 133 minutes of intraservice time, physicians are not typically furnishing the service over that entire time in terval; rather, hospital-employed pump technicians are furnishing much of the work.

Comment : We received no comments on these codes. Response : We are finalizing our proposal to revi ew these codes as potentially misvalued codes. CPT codes 47560 (Laparoscopy, surgical; with gui ded transhepatic cholangiography, without biopsy), 47562 (Laparoscopy, surgical; cholecy stectomy) and 47563 (Laparoscopy, surgical; cholecystectomy with cholangiography) were pr oposed as potentially misvalued because the more extensive code (CPT 47560) has lower work RVUs than the less extensive codes (CPT 47562 and CPT 47563).

### CMS-1600-FC 107

Comment : We received a comment suggesting that these codes were not potentially misvalued and urging us not to finalize our proposal, stating that 47562 and 47563 describe more complex surgical procedures and both have a 090-day global pe riod while 47560 has a 000-day global period. Response : We acknowledge that the codes have di fferent global periods, but believe that questions remain about how these code s should be valued. Therefore, we are finalizing our proposal to review these codes as potentially misvalued codes. CPT codes 55845 (Prostatectomy, retropubic radical, with or without nerve sparing; with bilateral pelvic lymphadenectomy, including external iliac, hypogastric, and obturator nodes) and 55866 (Laparoscopy, surgical prostatectomy, retropubic ra dial, including nerve sparing, includes robotic assistance, when performed) were proposed as pot entially misvalued because the RVUs for the laparoscopic procedure (CPT 55866) are higher than those for the open procedure (CPT 55845) and we believe that, in general, a laparoscopic procedur e would not require greater resources than the open procedure.

Comment : A few comments suggested that these cod es were not potentially misvalued because the laparoscopic code (CPT 55866) does require a hi gher level of work than the open procedure (CPT 55845) so the codes are in the appropriate rank order. One commenter stated that they had submitted an action plan for the review of these codes at the Oc tober 2013 AMA RUC meeting, and suggested that we defer any action on these codes until the AMA RUC re view process is complete. Another commenter agreed that they were potentially misvalued saying that we should pay the same rate for both codes. Response : Although most of the commenters indicated that it was appropriate that RVUs be higher for CPT code 55866 (laparoscopic procedure) than for CPT code 55845 (open procedure), we believe that there is enough question about how these codes should be valued that we are finalizing the proposal to review these codes as potentially misvalue d codes. We note that we consider AMA RUC recommendations through our usual review of potentially misvalued codes. We proposed CPT 64566 (Posterior tibial neurostimul ation, percutaneous needle electrode, single treatment, includes programming) as a potentially misval ued code because the current valuation is based

### CMS-1600-FC 108

on the procedure being furnished by a physician, but we think that the procedure typically is furnished by auxiliary personnel with physician superv ision (rather than by a physician).

Comment : We received a few comments stating that th is code is not misval ued and urged us not to finalize our proposal. One commenter disagrees that CPT code 64566 is potentially misvalued and

stated that the current work RVU of 0.60 is appropriate and should be maintained. Response : We believe that further review is needed to determine if this procedure is typically performed by the physician, or the auxiliary personne l with physician supervision. Therefore, we are finalizing our proposal to review the codes d escribed above as potentially misvalued codes. We proposed CPT code 76942 (Ultrasonic guidance for needle placement (for example, biopsy, aspiration, injection, localization device), imagi ng supervision and interpretation) as a potentially misvalued code because of the high frequency with which it is billed with CPT code 20610 (Arthrocentesis, aspiration and/or injection; major jo int or bursa (for example, shoulder, hip, knee joint, subacromial bursa). As we noted in the proposed ru le, we are concerned about potential overutilization of these codes and it was suggested th at the payment for CPT code 76 942 and CPT code 20610 should be bundled to reduce the incentive for providers to al ways provide and bill separately for ultrasound guidance. We also noted in the proposed rule that we were proposing to revise the direct PE inputs for CPT code 76942 because claims data shows that the pro cedure time assumption for CPT code 76942 is longer than that for the typical procedure with which the code is billed (CPT code 20610). The direct PE inputs and procedure time for CPT code 76942 are addressed in detail in section II.B.4.f. of this final rule with comment period. We further explained in the proposed rule that the discrepancy in procedure times and the resulting potentially inaccurate payment raises a fundamental concern regarding the incentive to furnish ultrasound guidance.

Comment : We received a comment saying that this code is undervalued, several comments indicating that the reduction of time and other in puts would be inappropriate and some comments suggesting that we should delay action until the AMA RUC can review and provide its recommendation.

### CMS-1600-FC 109

Response : Based on the diversity of the comments receiv ed about the valuation of this code, we are finalizing our proposal to review it as a potentially misvalued code. This acti on is consistent with the comment recommending that we delay action until th e AMA RUC acts because we routinely consider AMA RUC recommendations through our usual review of potentially misvalued codes. Thus, we would seek the AMA RUC recommendation before re-valuing. As we noted in the proposed rule that given our concerns with CPT code 76942, we have similar concerns with other codes for ultrasound guidance. Accordingly, we proposed the following additional ultrasound guidance codes as potentially misvalued. TABLE 12: Ultrasound Guidance Codes Proposed as Potentially Misvalued CPT Code Short Descriptor 76930 Echo guide cardiocentesis 76932 Echo guide for heart biopsy 76936 Echo guide for artery repair 76940 US guide tissue ablation 76948 Echo guide ova aspiration 76950 Echo guidance radiotherapy 76965 Echo guidance radiotherapy

Comment : We received some comments asking us not to treat 76930, 76932, and 76936 as potentially misvalued codes stating that these codes ar e not misvalued but without providing information to support the contention. One commenter stated th at 76936 should be removed from the list because it is not an image guidance technique used to supplement a surgical procedure. Response : We agree that code 76936 is not a code used to supplement a surgical procedure and

therefore does not raise the concerns we discussed in the proposed rule. Accordingly, it will not be included on the list of potentially misvalued codes. The comments on codes 76930 and 76932 provided insufficient information to persuade us that these c odes should not be considered potentially misvalued. Given that the identification of a code as potentially misvalued merely assures that the current values are evaluated to determine whether changes are warranted, we are finalizing our proposal to consider codes 76930 and 76932 as potentially misvalued.

### CMS-1600-FC 110

In summary, the following codes are fina lized as potentially misvalued codes. TABLE 13: Potentially Misvalued CPT Codes CPT Code Short Descriptor 21800 Treatment of rib fracture 22305 Closed tx spine process fx 27193 Treat pelvic ring fracture 33960 External circulation assist 33961 External circulation assist, each subsequent day 47560 Laparoscopy w/cholangio 47562 Laparoscopic cholecystectomy 47563 Laparo cholecystectomy/graph 55845 Extensive prostate surgery 55866 Laparo radical prostatectomy 64566 Neuroeltrd stim post tibial 76930 Echo guide cardiocentesis 76932 Echo guide for heart biopsy 76940 US guide tissue ablation 76942 Echo guide for biopsy 76948 Echo guide ova aspiration 76950 Echo guidance radiotherapy 76965 Echo guidance radiotherapy We will accept public nominations of potentially misvalued codes with supporting documentation

as described in section II.C.3.a. of this final rule with comment period in the CY 2015 proposed rule. ii. Number of Visits and Physician Time in Selected Global Surgical Packages In the CY 2013 proposed rule, we sought co mments on methods of obtaining accurate and current data on E/M services furnished as part of a global surgical package. Commenters provided a variety of suggestions including setting the all surg ical services to a 0-day global period, requiring all E/M services to be separately billed, validating the gl obal surgical packages w ith the hospital DiagnosisRelated Group length of stay data, and setting aud itable documentation standards for post-operative E/M services. In addition to the broader comments, the AMA RUC noted that many surgical procedures did not have the correct hospital and discharge day manage ment services in the global period, resulting in

incorrect times in the time file. The AMA RUC su bmitted post-operative visits and times for the services

### CMS-1600-FC 111

that we had displayed with zero visits in the CMS time file with the CY 2013 proposed rule. The AMA RUC suggested that the errors may have resulted from the inadvertent removal of the visits from the time file in 2007. We responded to this comment in the CY 2013 final rule with comment period by saying that we would review this file and, if appropriate , propose modifications. We noted in the CY 2013 final rule with comment period that if time had been re moved from the physician time file inadvertently, it would have resulted in a small impact on the indirect allocation of PE at the specialty level, but it would not have affected the physician work RVUs or direct PE inputs for these services. It would have a small impact on the indirect allocation of PE at the specia lty level, which we would review when we explore this potential time file change. After extensive review, we believe that the da ta were deleted from the time file due to an inadvertent error as noted by the AMA RUC. To co rrect this inadvertent error, in the CY2014 proposed rule, we proposed to replace the missing post-operativ e hospital E/M visit inform ation and time for the 117 codes that were identified by the AMA RUC and displayed in Table 14. Thus, we believe this correction will populate the physician time file with da ta that, absent the inadvertent error, would have been present in the time file. TABLE 14: Global Surgical Package Visits and Physician Time Changes Visits Included in Global Package 1 CPT Code Short Descriptor 99231 99232 99238 99291 CY 2013 Physician

Time CY 2014 Physician

Time 19368 Breast reconstruc tion 4.00 1.00 712.00 770.00 19369 Breast reconstruc tion 3.00 1.00 657.00 690.00 20100 Explore wound neck 2.00 1.00 218.00 266.00 20816 Replantation digit complete 5.00 1.00 671.00 697.00 20822 Replantation digit complete 3.00 1.00 587.00 590.00 20824 Replantation thumb complete 5.00 1.00 646.00 690.00 20827 Replantation thumb complete 4.00 1.00 610.00 625.00 20838 Replantation foot complete 8.00 1.00 887.00 986.00

1 We note that in the CY 2014 proposed rule, this table displayed only whole numbers of visits, although the actual time file and our ratesetting calculations use data to two places beyond the decimal point.

### CMS-1600-FC 112

Visits Included in Global Package 1 CPT Code Short Descriptor 99231 99232 99238 99291 CY 2013 Physician

Time CY 2014 Physician

Time 20955 Fibula bone graft microvasc 6.00 1.00 1.00 867.00 957.00 20969 Bone/skin graft micr ovasc 8.00 1.00 1018.00 1048.00 20970 Bone/skin graft iliac crest 8.00 1.00 958.00 988.00 20973 Bone/skin graft great toe 5.00 1.00 1018.00 988.00 21139 Reduction of forehead 1.00 1.00 400.00 466.00 21151 Reconstruct midface lefo rt 2.00 1.00 1.00 567.00 686.00 21154 Reconstruct midface lefo rt 2.50 1.00 1.50 664.00 853.00 21155 Reconstruct midface lefo rt 2.00 1.00 2.00 754.00 939.00 21175 Reconstruct orbit/foreh ead 1.00 1.00 2.00 549.00 767.00 21182 Reconstruct cranial bone 1.00 1.00 2.00 619.00 856.00 21188 Reconstruction of midface 1.00 1.00 512.00 572.00 22100 Remove part of neck vertebra 2.00 1.00 397.00 372.00 22101 Remove part thorax vertebra 3.00 1.00 392.00 387.00 22110 Remove part of neck vertebra 6.00 1.00 437.00 479.00 22112 Remove part thorax vertebra 6.50 1.00 507.00 530.00 22114 Remove part lumbar vertebra 6.50 1.00 517.00 530.00 22210 Revision of neck spine 7.00 1.00 585.00 609.00 22212 Revision of thorax spine 7.00 1.00 610.00 640.00 22214 Revision of lumbar spine 7.00 1.00 585.00 624.00 22220 Revision of neck spine 6.50 1.00 565.00 585.00 22222 Revision of thorax spine 7.50 1.00 630.00 651.00 22224 Revision of lumbar spine 7.50 1.00 620.00 666.00 22315 Treat spine fracture 1.00 1.00 257.00 252.00 22325 Treat spine fracture 5.50 1.00 504.00 528.00 22326 Treat neck spine fracture 5.50 1.00 452.00 480.00 22327 Treat thorax spine fracture 9.00 1.00 505.00 604.00 22548 Neck spine fusion 8.00 1.00 1.00 532.00 673.00 22556 Thorax spine fusion 3.00 1.00 1.00 525.00 557.00 22558 Lumbar spine fusion 2.00 1.00 1.00 502.00 525.00 22590 Spine & skull spinal fusion 3.00 1.00 532.00 501.00 22595 Neck spinal fusion 6.00 1.00 492.00 521.00 22600 Neck spine fusion 6.00 1.00 437.00 490.00 22610 Thorax spine fusion 7.50 1.00 468.00 549.00 22630 Lumbar spine fusion 3.00 1.00 501.00 487.00 22800 Fusion of spine 7.00 1.00 517.00 571.00 22802 Fusion of spine 4.00 1.00 552.00 538.00 22804 Fusion of spine 5.00 1.00 630.00 595.00 22808 Fusion of spine 5.00 1.00 553.00 530.00

### CMS-1600-FC 113

Visits Included in Global Package 1 CPT Code Short Descriptor 99231 99232 99238 99291 CY 2013 Physician

Time CY 2014 Physician

Time 22810 Fusion of spine 5.00 1.00 613.00 595.00 22812 Fusion of spine 7.50 1.00 666.00 700.00 31582 Revision of larynx 8.00 1.00 489.00 654.00 32650 Thoracoscopy w/pleurodesis 2.00 1.00 322.00 290.00 32656 Thoracoscopy w/pleurectomy 3.00 1.00 419.00 377.00 32658 Thoracoscopy w/sac fb

remove 1.00 1.00 362.00 330.00 32659 Thoracoscopy w/sac drai nage 2.00 1.00 414.00 357.00 32661 Thoracoscopy w/pericard exc 1.00 1.00 342.00 300.00 32664 Thoracoscopy w/ th nrv exc 1.00 1.00 362.00 330.00 32820 Reconstruct injured chest 3.50 1.00 4.50 631.00 854.00 33236 Remove electrode/thoracotomy 4.00 1.00 258.00 346.00

33237 Remove electrode/thoracotomy 5.00 1.00 378.00 456.00

33238 Remove electrode/thoracotomy 5.00 1.00 379.00 472.00 33243 Remove eltrd/thoracotomy 5.00 1.00 504.00 537.00 33321 Repair major v essel 8.00 1.00 751.00 754.00 33332 Insert major vessel graft 8.00 1.00 601.00 604.00 33401 Valvuloplasty open 8.00 1.00 830.00 661.00 33403 Valvuloplasty w/cp bypass 8.00 1.00 890.00 638.00 33417 Repair of aortic valve 2.50 1.00 2.50 740.00 750.00 33472 Revision of pulmonary valve 0.50 1.00 4.50 665.00 780.00 33502 Coronary artery correction 2.50 1.00 2.50 710.00 688.00 33503 Coronary artery graft 5.50 1.00 2.50 890.00 838.00 33504 Coronary artery graft 4.50 1.00 2.50 740.00 789.00 33600 Closure of valve 6.00 1.00 800.00 628.00 33602 Closure of valve 6.00 1.00 770.00 628.00 33606 Anastomosis/artery-aorta 8.00 1.00 860.00 728.00 33608 Repair anomaly w/conduit 5.00 1.00 800.00 668.00 33690 Reinforce pulmonary artery 2.50 1.00 2.50 620.00 636.00 33702 Repair of heart defects 0.50 1.00 3.50 663.00 751.00 33722 Repair of heart defect 5.00 1.00 770.00 608.00 33732 Repair heart-vein defect 5.00 1.00 710.00 578.00 33735 Revision of heart chamber 2.50 1.00 3.50 740.00 770.00 33736 Revision of heart chamber 5.00 1.00 710.00 548.00 33750 Major vessel shunt 2.00 1.00 3.00 680.00 722.00 33764 Major vessel shunt & gr aft 1.50 1.00 3.50 710.00 750.00

### CMS-1600-FC 114

Visits Included in Global Package 1 CPT Code Short Descriptor 99231 99232 99238 99291 CY 2013 Physician

Time CY 2014 Physician

Time 33767 Major vessel shunt 5.00 1.00 800.00 608.00 33774 Repair great vessels de fect 0.50 1.00 6.50 845.00 998.00 33788 Revision of pulmonary artery 2.50 1.00 2.50 770.00 736.00 33802 Repair vessel defect 2.50 1.00 1.50 558.00 556.00 33803 Repair vessel defect 2.50 1.00 1.50 618.00 586.00 33820 Revise major vessel 1.00 1.00 1.00 430.00 414.00 33824 Revise major vessel 0.50 1.00 2.50 588.00 615.00 33840 Remove aorta constriction 1.50 1.00 2.50 588.00 639.00 33845 Remove aorta constriction 1.00 1.00 3.00 710.00 726.00 33851 Remove aorta constriction 2.00 1.00 3.00 603.00 700.00 33852 Repair septal defect 2.00 1.00 3.00 663.00 719.00 33853 Repair septal defect 8.00 1.00 800.00 668.00 33917 Repair pulmonary artery 5.00 1.00 740.00 608.00 33920 Repair pulmonary atresia 6.00 1.00 800.00 658.00 33922 Transect pulmonary ar tery 5.00 1.00 618.00 546.00 33974 Remove intra-aortic balloon 1.00 1.00 406.00 314.00 34502 Reconstruct vena cava 6.00 1.00 793.00 741.00 35091 Repair defect of artery 11.00 1.00 2.00 597.00 790.00 35694 Arterial transposition 2.00 1.00 468.00 456.00 35901 Excision graft neck 4.00 1.00 484.00 482.00 35903 Excision graft extremity 3.00 1.00 408.00 416.00 47135 Transplantation of liver 23.00 1.00 1501.00 1345.00 47136 Transplantation of liver 28.00 1.00 1301.00 1329.00 49422 Remove tunneled ip cath 1.00 1.00 154.00 182.00 49429 Removal of shunt 6.00 1.00 249.00 317.00 50320 Remove kidney living donor 4.00 1.00 480.00 524.00 50845 Appendico-vesicostomy 5.00 1.00 685.00 613.00 56632 Extensive vulva surgery 7.00 1.00 835.00 683.00 60520 Removal of thymus gland 2.00 1.00 2.00 406.00 474.00 60521 Removal of thymus gland 5.00 1.00 457.00 445.00 60522 Removal of thymus gland 7.00 1.00 525.00 533.00 61557 Incise skull/sutures 3.00 1.00 529.00 510.00 63700 Repair of spinal herniation 3.00 1.00 399.00 401.00 63702 Repair of spinal herniation 3.00 1.00 469.00 463.00 63704 Repair of spinal herniation 8.00 1.00 534.00 609.00 63706 Repair of spinal herniation 8.00 1.00 602.00 679.00

iii. Codes with Higher Total Medicare Paymen ts in Office than in Hospital or ASC

### CMS-1600-FC 115

In the CY 2014 proposed rule with comment period, we proposed to address nearly 200 codes that we believe to have misvalued resource input s. These are codes for which the total PFS payment when furnished in an office or other nonfacility setting would exceed the total Medicare payment (the combined payment to the facility and the professional) when the service is furnished in a facility, either a hospital outpatient department or an ASC. For services furnished in a facility setting we woul d generally expect the combined payment to the facility and the practitioner to exceed the PFS paym ent made to the professional when the service is furnished in the nonfacility setting. This payment diffe rential is expected because it reflects the greater costs we would expect to be incurred by facilities rela tive to physicians furnishing services in offices and other non-facility settings. These greater costs are due to higher overhead resulting from differences in regulatory requirements and for facilities, such as hos pitals, maintaining the capacity to furnish services 24 hours per day and 7 days per week. However, when we analyzed such payments, we identified nearly 300 codes that would result in greater Medicare paym ent in the nonfacility setting than in the facility setting. We believe these anomalous site-of-service payment differentials are the result of inaccurate resource input data used to establish rates under the PFS. We proposed to address these misvalued codes by refining the PE methodology to limit the nonfacility PE RVUs for individual codes so that the total nonfacility PFS payment amount would not exceed the total combined payment under the PFS a nd the OPPS (or the ASC payment system) when the service is furnished in the facility setting.

Section II.B.3 discusses the comment received on this misvalued code proposal and our response

to these comments. 4. Multiple Procedure Payment Reduction Policy Medicare has long employed multiple procedure payment reduction (MPPR) policies to adjust payment to more appropriately reflect reduced r esources involved with furnishing services that are frequently furnished together. Under these policies, we reduce payment for the second and subsequent services within the same MPPR category furnished in the same session or same day. These payment

### CMS-1600-FC 116

reductions reflect efficiencies that typically occur in either the PE or professional work or both when services are furnished together. With the exception of a few codes that are always reported with another code, the PFS values services independently to rec ognize relative resources involved when the service is the only one furnished in a session. Although some of our MPPR policies precede the Affordable Care Act, MPPRs can address the fourth category of potentially misvalued codes identified in section 1848(c)(2)(K) of the Act, as added by the Affordable Care Act, which is “multiple codes that are frequently billed in conjunction with furnishing a single service” (see 75 FR 73216). The following sections describe the history of MPPRs and the services currently covered by MPPRs. a. Background Medicare has a longstanding policy to reduce payment by 50 percent for the second and subsequent surgical procedures furnished to the same beneficiary by a single physician or physicians in the same group practice on the same day, largely b ased on the presence of efficiencies in the PE and preand post-surgical physician work. Effective January 1, 1995, the MPPR policy, with this same percentage reduction, was extended to nuclear medicine di agnostic procedures (CPT codes 78306, 78320, 78802, 78803, 78806, and 78807). In th e CY 1995 PFS final rule with co mment period (59 FR 63410), we indicated that we would consider applying the po licy to other diagnostic tests in the future.

Consistent with recommendations of MedP AC in its March 2005 Report to the Congress on Medicare Payment Policy, for CY 2006 PFS, we extended the MPPR policy to the TC of certain diagnostic imaging procedures furnished on co ntiguous areas of the body in a single session (70 FR 70261). This MPPR policy recognizes that for the second and subsequent imaging procedures furnished in the same session, there are some efficien cies in clinical labor, supplies, and equipment time. In particular, certain clinical labor activities and supplies are not duplicated for subsequent imaging services in the same session and, because equipmen t time and indirect costs are allocated based on clinical labor time, adjustment to those figures is appropriate as well. The imaging MPPR policy originally applied to computed tomography (CT) and computed tomographic angiography (CTA), magnetic res onance imaging (MRI) and magnetic resonance

### CMS-1600-FC 117

angiography (MRA), and ultrasound services within 11 families of codes based on imaging modality and body region, and only applie d to procedures furnished in a single session involving contiguous body areas within a family of codes. Additionally, this MPPR policy originally applied to TC-only services and to the TC of global services, but not to professional component (PC) services. There have been several revisions to this polic y since it was originally adopted. Under the current imaging MPPR policy, full payment is made for the TC of the highest paid procedure, and payment for the TC is reduced by 50 percent for each a dditional procedure subject to this MPPR policy. We originally planned to phase in the imaging MPPR policy over a 2-year period, with a 25 percent reduction in CY 2006 and a 50 percent reduction in CY 2007 (70 FR 70263). However, section 5102(b) of the Deficit Reduction Act of 2005 (DRA) (Pub. L. 109–171, enacted on December 20, 2006) amended the statute to place a cap on the PFS payment amount for most imaging procedures at the amount paid under the hospital OPPS. In view of this new O PPS payment cap, we decided in the CY 2006 PFS final rule with comment period that it would be prudent to retain the imaging MPPR at 25 percent while we continued to examine the appropriate payment levels (71 FR 69659). The DRA also exempted reduced expenditures attributable to the imaging MPPR policy from the PFS budget neutrality provision. Effective July 1, 2010, section 1848(b)(4)(C) of the Act increased the MPPR on the TC of imaging services under the policy established in the CY 2006 PFS final rule with comment period from 25 to 50 percent. Section 1848(c)(2)(B)(v)(IV) of the Act ex empted the reduced expenditures attributable to this further change from the PFS budget neutrality provision. In the July 2009 U.S. Government Accountability Office (GAO) report entitled, Medicare Physician Payments: Fees Could Better Reflect E fficiencies Achieved when Services are Provided Together , the GAO recommended that we take further steps to ensure that fees for services paid under the

PFS reflect efficiencies that occu r when services are furnished by the same physician to the same beneficiary on the same day. The GAO report reco mmended the following: (1) expanding the existing imaging MPPR policy for certain services to the PC to reflect efficiencies in physician work for certain imaging services; and (2) expanding the MPPR to reflect PE efficiencies that occur when certain

### CMS-1600-FC 118

nonsurgical, nonimaging services are furnished together. The GAO report also encouraged us to focus on service pairs that have the most impact on Medicare spending. In its March 2010 report, MedPAC noted its concerns about mispricing of services under the PFS. MedPAC indicated that it would explore whether expanding the unit of payment through packaging or bundling would improve payment accuracy and encourage more efficient use of services. In the CY 2009 and CY 2010 PFS proposed rules (73 FR 38586 and 74 FR 33554, resp ectively), we stated that we planned to analyze nonsurgical services commonly furnished together (for example, 60 to 75 percent of the time) to assess whether an expansion of the MPPR policy could be warranted. MedPAC encouraged us to consider duplicative physician work, as we ll as PE, in any expansion of the MPPR policy. Section 1848(c)(2)(K) of the Act specifies that th e Secretary shall identify potentially misvalued codes by examining multiple codes that are frequen tly billed in conjunction with furnishing a single service, and review and make appropriate adjustments to their relative values. As a first step in applying this provision, in the CY 2010 final rule with comme nt period, we implemente d a limited expansion of the imaging MPPR policy to additional combinations of imaging services. Effective January 1, 2011, the imaging MPPR a pplies regardless of code family; that is, the policy applies to multiple imaging services furnished with in the same family of codes or across families. This policy is consistent with the standard PFS MPPR policy for surgical procedures that does not group procedures by body region. The current imaging MPPR policy applies to CT and CTA, MRI and MRA, and ultrasound procedures furnished to the same be neficiary in the same session, regardless of the imaging modality, and is not limited to contiguous body areas.

As we noted in the CY 2011 PFS final rule w ith comment period (75 FR 73228), although section 1848(c)(2)(B)(v)(VI) of the Act specifies that reduced expenditures attributable to the increase in the imaging MPPR from 25 to 50 percent (effective for fe e schedules established beginning with 2010 and for services furnished on or after July 1, 2010) are ex cluded from the PFS budget neutrality adjustment, it does not apply to reduced expenditures attributable to our policy change re garding additional code combinations across code families (noncontiguous body areas) that are subject to budget neutrality under

### CMS-1600-FC 119

the PFS. The complete list of codes subject to th e CY 2011 MPPR policy for diagnostic imaging services

is included in Addendum F. As a further step in applying the provisions of section 1848(c)(2)(K) of the Act, on January 1, 2011, we implemented an MPPR for th erapy services. The MPPR applies to separately payable “always therapy” services, that is, services that are only paid by Medicare when furnished under a therapy plan of care. As we explained in the CY 2011 PFS final rule with comment period (75 FR 73232), the therapy MPPR does not apply to contractor-priced codes, bundled codes, or add-on codes. This MPPR for therapy services was first proposed in the CY 2011 proposed rule (75 FR 44075) as a 50 percent payment reduction to the PE componentof the second and subsequent therapy services for multiple “always therapy” services furnished to a single beneficiary in a single day. It applies to services furnished by an individual or group practice or “incid ent to” a physician’s service. However, in response to public comments, in the CY 2011 PFS final rule with comment period (75 FR 73232), we adopted a 25 percent payment reduction to the PE component of the second and subsequent therapy services for multiple “always therapy” services furnished to a single beneficiary in a single day. Subsequent to publication of the CY 2011 PFS fi nal rule with comment period, section 3 of the Physician Payment and Therapy Re lief Act of 2010 (PPTRA) (Pub. L. 111-286) revised the payment reduction percentage from 25 percent to 20 percent fo r therapy services for which payment is made under a fee schedule under section 1848 of the Act (which are services furnished in office settings, or noninstitutional services). The payment reduction percen tage remained at 25 percent for therapy services furnished in institutional settings. Section 4 of the PPTRA exempted the reduced expenditures attributable to the therapy MPPR policy from the PF S budget neutrality provision. Section 633 of the ATRA revised the reduction to 50 percent of the PE co mponent for all settings, effective April 1, 2013. Therefore, full payment is made for the service or unit with the highest PE and payment for the PE component for the second and subsequent procedures or a dditional units of the same service is reduced by 50 percent for both institutional and non-institutional services.

### CMS-1600-FC 120

This MPPR policy applies to multiple units of the same therapy service, as well as to multiple different “always therapy” services, when furnished to the same beneficiary on the same day. The MPPR applies when multiple therapy services are billed on the same date of service for one beneficiary by the same practitioner or facility under the same National Pr ovider Identifier (NPI), regardless of whether the services are furnished in one therapy discipline or multiple disciplines, including physical therapy, occupational therapy, or sp eech-language pathology. The MPPR policy applies in all settings where outpa tient therapy services are paid under Part B.

This includes both services that are furnished in the office setting and paid under the PFS, as well as institutional services that are furnished by outpatie nt hospitals, home health agencies, comprehensive outpatient rehabilitation facilities (CORFs), and other en tities that are paid for outpatient therapy services

at rates based on the PFS. In its June 2011 Report to Congr ess, MedPAC highlighted continued growth in ancillary services subject to the in-office ancillary services exception. The in-office ancillary ex ception to the physician self-referral prohibition in section 1877 of the Act, also known as the Stark law, allows physicians to refer Medicare beneficiaries to their own group practices for designated health services, including imaging, radiation therapy, home health care, clinical laborator y tests, and physical therapy, if certain conditions

are met. MedPAC recommended that we curb ove rutilization by applying a MPPR to the PC of diagnostic imaging services furnished by the same prac titioner in the same session. As noted above, the GAO already had made a similar recomm endation in its July 2009 report. In continuing to apply the provisions of secti on 1848(c)(2)(K) of the Act regarding potentially misvalued codes that result from “multiple codes that are frequently billed in co njunction with furnishing a single service,” in the CY 2012 final rule (76 FR 73071), we expanded the MPPR to the PC of Advanced Imaging Services (CT, MRI, and Ultrasound) , that is, the same list of codes to which the MPPR on the TC of advanced imaging already applied. Thus, this MPPR policy now applies to the PC and the TC of certain diagnostic imaging codes. Specifically, we expanded the payment reduction currently applied to the TC to apply also to th e PC of the second and sub sequent advanced imaging

### CMS-1600-FC 121

services furnished by the same physician (or by two or more physicians in the same group practice) to the same beneficiary in the same session on the same day. However, in r esponse to public comments, in the CY 2012 PFS final rule with comment period, we adopted a 25 percent payment reduction to the PC component of the second and subsequent imaging services. Under this policy, full payment is made for the PC of the highest paid advanced imaging service, and payment is reduced by 25 percent for the PC fo r each additional advanced imaging service furnished to the same beneficiary in the same session. This policy was based on the expected efficiencies in furnishing multiple services in the sa me session due to duplication of physician work, primarily in the pre- and post-service periods, but with so me efficiencies in the intraservice period. This policy is consistent with the statutory requi rement for the Secretary to identify, review, and adjust the relative values of potentially misv alued services under the PFS as specified by section 1848(c)(2)(K) of the Act. This policy is also consis tent with our longstanding policies on surgical and nuclear medicine diagnostic procedures, under whic h we apply a 50 percent payment reduction to second and subsequent procedures. Furthermore, it was r esponsive to continued concerns about significant growth in imaging spending, and to MedPAC (March 2010 and June 2011) and GAO (July 2009) recommendations regarding the expa nsion of MPPR policies under the PFS to account for additional

efficiencies. In the CY 2013 final rule (77 FR 68933), we expanded the MPPR to the TC of certain cardiovascular and ophthalmology diagnostic tests. Although we proposed a 25 percent reduction for both diagnostic cardiovascular and ophthalmology services, we adopted a 20 percent reduction for ophthalmology services in the final rule with comme nt period (77 FR 68941) in response to public comments. For diagnostic cardiovascular services, fu ll payment is made for the procedure with the highest TC payment, and payment is reduced by 25 percent for the TC for each additional procedure furnished to the same patient on the same day. For diagnostic ophthalmology services, full payment is made for the procedure with the highest TC payment, and payment is reduced by 20 percent for the TC for each additional procedure furnished to the same patient on the same day.

### CMS-1600-FC 122

We did not propose and are not adopting any new MPPR policies for CY 2014. However, we continue to look at expanding the MPPR based on e fficiencies when multiple procedures are furnished together. The complete list of services subject to the MPPRs on diagnostic imaging services, therapy services, diagnostic cardiovascular services and diagnos tic ophthalmology services is shown in Addenda F, H, I, and J. We note that Addenda H, which lists services subject to the MPPR on therapy services, contains four new CPT codes. Specifically, C PT code 92521 (Evaluation of speech fluency), 92522 (Evaluate speech sound production), 92523 (Speech sound language comp rehension) and 92524 (Behavioral and qualitative analysis of voice and r esonance) are being added to the list. These codes replace CPT code 92506 (Speech/hearing evaluation) fo r CY 2014. Accordingly, CPT 92506 has been

deleted from Addenda H. Like C PT 92506, these new codes are “always therapy” services that are only paid by Medicare when furnished under a therapy plan of care. Thus, like CPT 92506, they are subject to the MPPR for therapy services. They have been a dded to the list of services subject to the MPPR on therapy services on an interim final basis, and are open to public comment on this final rule with comment period.

### CMS-1600-FC 123

C. Malpractice RVUs Section 1848(c) of the Act requires that each ser vice paid under the PFS be composed of three components: work, PE, and malpractice. From 1992 to 1999, malpractice RVUs were charge-based, using weighted specialty-specific malpractice expens e percentages and 1991 average allowed charges. Malpractice RVUs for new codes after 1991 were extrapolated from similar existing codes or as a percentage of the corresponding work RVU. Section 4505(f) of the BBA, which amended section 1848(c) of the Act, required us to implement res ource-based malpractice RVUs for services furnished beginning in 2000. Therefore, initial implementati on of resource-based malpractice RVUs occurred in

2000. The statute also requires that we review and, if necessary, adjust RVUs no less often than every 5 years. The first review and corresponding update of resource-based malpractice RVUs was addressed in the CY 2005 PFS final rule with comment period (69 FR 66263). Minor modifications to the methodology were addressed in the CY 2006 PFS final rule with comment period (70 FR 70153). In the CY 2010 PFS final rule with comment period, we implemented the second review and corresponding update of malpractice RVUs. For a discussion of th e second review and update of malpractice RVUs, see the CY 2010 PFS proposed rule (74 FR 33537) and final rule with comment period (74 FR 61758). As explained in the CY 2011 PFS final rule w ith comment period (75 FR 73208), malpractice RVUs for new codes, revised codes and codes with revised work RVUs (new/revised codes) effective before the next five-year review of malpractice RV Us (for example, effective CY 2011 through CY 2014, assuming that the next review of malpractice RVUs occu rs for CY 2015) are determined either by a direct crosswalk from a similar source code or by a modi fied crosswalk to account for differences in work

RVUs between the new/revised code and the source code. For the modified crosswalk approach, we adjust (or “scale”) the malpractice RVU for the new/re vised code to reflect the difference in work RVU

between the source code and the new/revised work valu e (or, if greater, the clinical labor portion of the PE RVU) for the new code. For example, if the pr oposed work RVU for a revised code is 10 percent higher than the work RVU for its source code, the malpractice RVU for the revised code would be

### CMS-1600-FC 124

increased by 10 percent over the source code malprac tice RVU. This approach presumes the same risk

factor for the new/revised code and source code but uses the work RVU for the new/revised code to adjust

for the difference in risk attributable to th e variation in work between the two services. For CY 2014, we use this approach for determini ng malpractice RVUs for new/revised codes. A list of new/revised codes and the malpractice crosswalks used to determine their malpractice RVUs are in

Sections II.E.2.c and 3.c in this final rule with comment period. The CY 2014 malpractice RVUs for interim final codes are being implemented in the CY 2014 PFS final rule with comment period. These RVUs are subject to public comment. After consideri ng public comments, they will then be finalized in the CY 2015 PFS final rule with comment period.

### CMS-1600-FC 125

D. Medicare Economic Index (MEI) 1. Revising of the Medicare Economic Index (MEI) a. Background The Medicare Economic Index (MEI) is aut horized under section 1842(b)(3) of the Act, which states that prevailing charge levels be ginning after June 30, 1973 may not exceed the level from the previous year except to the extent that the Secretary finds, on th e basis of appropriate economic index data, that such a higher level is justified by year-to-ye ar economic changes. Beginning July 1, 1975, and continuing through today, the MEI has met this requirement by reflecting the weighted-average annual price change for various inputs involved in furnishing physicians’ services. The MEI is a fixed-weight input price index, with an adjustment for the change in economy-wide, private nonfarm busin ess multifactor productivity. This index is comprised of two broad categories: (1) physic ians’ own time; and (2 ) physicians’ practice expense (PE). The current general form of the MEI was described in the November 25, 1992 Federal Register (57 FR 55896) and was based in part on the recommendations of a Congressionallymandated meeting of experts held in March 1987. Since that tim e, the MEI has been updated or revised on four instances. First, the MEI wa s rebased in 1998 (63 FR 58845), which moved the

cost structure of the index from 1992 data to 1996 data. Second, the methodology for the productivity adjustment was revised in the CY 2003 PFS final rule with comment period (67 FR 80019) to reflect the percentage change in the 10-year moving average of economy-wide private nonfarm business multifactor productivity. Third, the MEI was rebased in 2003 (68 FR 63239),

which moved the cost structure of the index fr om 1996 data to 2000 data. Fourth, the MEI was

### CMS-1600-FC 126

rebased in 2011 (75 FR 73262), which moved the cost structure of the index from 2000 data to

2006 data. The terms ‘‘rebasing’’ and ‘‘revising,’’ while often used interchangeably, actually denote different activities. Rebasing refers to moving the base year for the structure of costs of a price index, while revising relates to other types of changes such as changing data sources, cost categories, or price proxies used in the price index. For CY 2 014, we proposed to revise the MEI

based on the recommendations of the MEI Tec hnical Advisory Panel (TAP). We did not propose to rebase the MEI and will continue to use the data from 2006 to estimate the cost weights, since these are the most recently avai lable, relevant, and complete data we have available to develop these weights. b. MEI Technical Advisory Panel (TAP) Recommendations

The MEI-TAP was convened to conduct a tec hnical review of the MEI, including the inputs, input weights, price-measurement pr oxies, and productivity adjustment. After considering these issues, the MEI-TAP was asked to assess the relevance and accuracy of inputs relative to current physician pr actices. The MEI-TAP’s analysis and recommendations were to be considered in future rulemaking to ensure th at the MEI accurately and appropriately meets its intended statutory purpose.

The MEI-TAP consisted of five members and held three meetings in 2012: May 21; June 25; and July 11. It produced eight findi ngs and 13 recommendations for consideration by CMS. Background on the MEI-TAP members, mee ting transcripts for a ll three meetings, and the MEI-TAP’s final report, including all fi ndings and recommendations, are available at http://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/MEITAP.html. 

### We have determined, as noted in the proposed rule, that it is possi ble to implement some of the recommendations

### CMS-1600-FC 127

immediately, while more in-depth research is required to address several of the other

recommendations. For CY 2014, we proposed to implement 10 of the 13 recommendations made by the MEI-TAP. The remaining recommendations requ ire more in-depth research, and we will continue evaluating these three recommendations and will propose any further changes to the MEI in future rulemaking. The CY 2014 changes only involve revising the MEI categories, cost shares, and price proxies. Agai n, we did not propose to rebase the MEI for CY 2014 since the MEI-TAP concluded that there is not a newer, relia ble, or ongoing source of data to maintain the

MEI.

c. Overview of Revisions

The MEI was last rebased and revised in the CY 2011 PFS final rule with comment period (75 FR 73262 – 73275). The current base year for the MEI is 2006, which means that the cost weights in the index refl ect physicians’ expenses in 2006 . The details of the methodology

used to determine the 2006 cost shares were provided in the CY 2011 PFS proposed rule and

finalized in the CY 2011 PFS final rule w ith comment period (75 FR 40087 and 75 FR 73262, respectively). For CY 2014 we proposed to ma ke the following revisions to the 2006-based

MEI: (1) Reclassify and revise certain cost categories:

● Reclassify expenses for non-physician clin ical personnel that can bill independently from non-physician compensation to physician compensation.

● Revise the physician wage a nd benefit split so th at the cost weights are more in line with the definitions of the price pr oxies used for each category.

### CMS-1600-FC 128

● Add an additional subcategory under non-physician compensation for health-related

workers.

● Create a new cost cate gory called “All Other Professi onal Services” that includes expenses covered in the current MEI categories: “All Other Services” an d “Other Professional Expenses.” The “All Other Prof essional Services” category would be further disaggregated into appropriate occupati onal subcategories.

● Create an aggregate cost category called “Miscellaneous Office Expenses” that would include the expenses for “Rubber and Plastics,” “Chemicals,” “All Other Products,” and “Paper.” (2) Revise price proxies:

● Revise the price proxy for physician wa ges and salaries from the Average Hourly Earnings (AHE) for the Total Private Nonf arm Economy for Production and Nonsupervisory Workers to the ECI for Wages and Salaries, Professional and Related Occupations, Private Industry.

● Revise the price proxy for physician benef its from the ECI for Benefits for the Total Private Industry to the ECI for Benefits, Profes sional and Related Occupations, Private Industry.

● Use the ECI for Wages and Salaries and the ECI for Benefits of Hospital, Civilian workers (private industry) as the price proxies for the new ca tegory of non-phys ician healthrelated workers.

● Use ECIs to proxy the Profe ssional Services occupational s ubcategories that reflect the type of professional services purchased by physicians’ offices.

● Revise the price proxy for the fixed capital category from the CPI for Owners’ Equivalent Rent of Residences to the PPI for Lessors of N onresidential Buildings (NAICS 53112).

### CMS-1600-FC 129

d. Revising Expense Categories in the MEI We did not propose any changes in the met hodology for estimating the cost shares as

finalized in the CY 2011 PFS final rule with comment period (75 FR 73263 - 73267). For CY 2014, we proposed to revise the classification of certain expenses within the 2006-based MEI. The details of the proposed revisions and the ME I-TAP recommendation that is the impetus for

each of the revisions can be found in th e CY 2014 PFS proposed rule (78 FR 43312 - 43316). The following sections summarize the proposed revisions to the cost weights for CY 2014. (1) Overall MEI Cost Weights.

Table 15 lists the set of mutu ally exclusive and exhaustive cost categories and weights that were proposed for CY 2014. A comparison of the proposed revised MEI cost categories and cost shares to the 2006-based MEI cost categorie s and cost shares as finalized in the CY 2011

PFS final rule can be found at 78 FR 43312-43313. Based on the proposed revisions to the MEI for CY 2014, the proposed physician compensation cost weight under the revised ME I is 2.600 percentage po ints higher than the physician compensation weight in the current ME I. This change occurs because of the reclassification of expenses for non-physician clin ical staff that can bi ll independently from nonphysician compensation to physician compensation. This change lowers the PE cost weight by 2.600 percent as well, all of which comes from a lower weight for non-physician compensation. The remaining MEI cost weights are unchanged. The proposed revised MEI includes four ne w detailed cost categor ies and two new subaggregate cost categories. The new detailed cost categories are:

● Health-related, non-physician wages and salaries.

● Professional, scientific , and technical services.

### CMS-1600-FC 130

● Administrative support and waste management services.

● All other services. The new sub-aggregate categories are:

● Non-health, non-physician wages.

● Miscellaneous office expenses. The proposed revised MEI excludes two sub-ag gregate categories that were included in

the current 2006-based MEI. The sub- aggregate categories removed are:

● Office expenses.

● Drugs & supplies.

### CMS-1600-FC 131

TABLE 15: Revised 2006 MEI Cost Categories and, Weights

Revised MEI (2006=100), CY2014 Revised Cost Category Revised Weights Physician Compensation 50.866% Wages and Salaries 43.641% Benefits 7.225% Practice Expense 49.134% Non-physician compensation 16.553% Non-physician wages 11.885% Non-health, non-physician wages 7.249% Professional and Related 0.800% Management 1.529% Clerical 4.720% Services 0.200% Health related, non-physician wages 4.636% Non-physician benefits 4.668% Other Practice Expense 32.581% Utilities 1.266% Miscellaneous Office Expenses 2.478% Chemicals 0.723% Paper 0.656% Rubber & Plastics 0.598% All other products 0.500% Telephone 1.501% Postage 0.898% All Other professional services 8.095% Professional, sc ientific, & techni cal services 2.592% Administrative support & waste management 3.052% All other services 2.451% Capital 10.310% Fixed Capital 8.957% Moveable Capital 1.353% Professional Liability Insurance 4.295% Medical Equipment 1.978% Medical supplies 1.760% Total MEI 100.000% * The term (2006=100) refers to the base year of the MEI.

### CMS-1600-FC 132

(2) Physician Compensation (Own time). The component of the MEI that reflects th e physician’s own time is represented by the net income portion of business receipts. The 2006 cost weight associated with the physician’s own time (otherwise referred to as the Physic ian’s Compensation cost weight) is based on 2006 AMA PPIS data for mean physician net income (physician compensation) for self-employed physicians and for the selected self-employed specialties. Expenses for employed physician compensation are combined with expenses for self-employed physician compensation to obtain an aggregate Physician Compensation cost we ight. Based on this methodology, the Physician Compensation cost weight in the current MEI is 48.266 percent. For CY 2014, we proposed to reclassify the expenses for non-physician practiti oners that can bill independently from the nonphysician cost category in the MEI to the physician compensati on cost category for several

reasons:

● These types of practitioners furnish servic es that are similar to those furnished by physicians.

● If billing independently, th ese practitioners would be pa id at a percentage of the physicians’ services or in certain ca ses at the same rate as physicians.

● The expenses related to the work compone nts for the RVUs would include work from

clinical staff that can bill independently. Therefore, it woul d improve consistency with the RVU payments to include these expenses as physician compensation in the MEI. The effect of moving the expenses related to clinical staff that can bill independently is to increase the physician compensation cost share by 2.600 percentage points and to reduce the non-physician compensation cost share by the sa me amount. The physician compensation cost

### CMS-1600-FC 133

share for the proposed revised MEI is 50.866 perc ent compared to the physician compensation cost share of 48.266 percen t in the current MEI. Within the physician compensation cost weight , the MEI includes a separate weight for wages and salaries and a separate weight for benefits. Under the current 2006-based MEI, the ratio for wages and salaries, and benefits wa s calculated using data from the PPIS. - Based on MEI-TAP recommendation 3.1 we proposed to revise the wage and benefit split used for physician compensation. Specifically, we proposed to apply the distribution from the Statistics of Income ( 

### SOI) data to both self-employed a nd employed physician compensation. In reviewing the detailed AMA PPIS survey questions, it was clear that self-employed physician benefits were mainly comprised of insurance costs while other benefits such as physician retirement, paid leave, and payroll taxes were li kely included in physician wages and salaries. By definition, the price proxy used for physicia n benefits, which is an Employment Cost Index (ECI) concept, includes retirement savings . Thus, using the AMA PPIS data produced a definitional inconsistency between the cost weig ht and the price proxy. Therefore, we proposed to use the data on wages and salaries, and employ ee benefits from the SOI data for Offices of Physicians and Dentists for partnerships and corporations for both self-employed and employed physicians. From the SOI data, benefit expens es were estimated by summing the partnership data for retirement plans and employee benef it programs with corporation data for pension, profit-sharing plans and employee benefit progr ams. For 2006, the split between wages and salaries, and benefits was 85.8 percent and 14.2 pe rcent, respectively. Retirement/pension plans account for about 60 percent of to tal benefits. The SOI data do not classify paid leave and supplemental pay as a benefit.

### CMS-1600-FC 134

Combining the impact of classifying comp ensation for non-physicians that can bill independently as physician compensation with th e use of the SOI data, the physician wages and salary cost share in the revised MEI is lower than the current MEI by 0.240 percentage points. These two methodological changes result in an incr ease in the physician bene fit cost share in the revised MEI of 2.839 percentage points. As a re sult, the proposed physician wages and salary cost share for the revised MEI is 43.641 percen t and the proposed physicia n benefit cost share for the revised MEI is 7.225 percent. (3) Physician’s Practice Expenses To determine the PE cost weights, we use mean expense data from the 2006 PPIS survey. The derivation of the weights and categories for pract ice expenses is the same as finalized in the CY 2011 PFS final rule with comment period (7 5 FR 73264-73267), except where noted below. (a) Non-physician Employee Compensation For CY 2014 we proposed to exclude the expe nses related to non-phys ician clinical staff that can bill independently from this cost category. Moving the e xpenses related to the clinical staff that can bill independently out of non-phys ician compensation costs decreases the share by 2.600 percentage points. The non-physician compen sation cost share for the revised MEI is 16.553 percent compared to the current physicia n compensation cost share of 19.153 percent. We are further proposed to use the same method as finalized in the CY 2011 PFS final rule to split the non-physician compensation between wages and benefits. For reference, we use 2006 BLS Employer Costs for Employee Compensati on (ECEC) data for the Health Care and Social Assistance (private indus try). Data for 2006 in the ECEC for Health Care and Social Assistance indicate that wages and benefits are 71.8 percent and 28.2 pe rcent of compensation,

### CMS-1600-FC 135

respectively. The non-physician wage and bene fit cost shares for the revised MEI are 11.885 percent and 4.668 percent, respectively. The current 2006-based MEI further disaggreg ated the non-physician wages into four occupational subcategories, the details of th is method can be found in the CY 2011 PFS final rule with comment period (75 FR 73264-73265) . Based on the MEI-TAP Recommendation 4.4, the Panel recommended the disaggregation of th e non-physician compensation costs to include an additional category for health-related worker s. The exact recommendation can be found at 78

FR 43314. We proposed to implement this recommenda tion using expenses reported on the AMA PPIS for non-physician, non-health-related workers. The survey question asks for the expenses for: “non-clinical personnel involved primarily in administrative, secretarial or clerical activities (Including transcriptionists, medical records personnel, receptionists, schedulers and billing staff, coding staff, information technol ogy staff, and custodial personne l).” Using this method, the proposed non-physician, non-health-rel ated wage cost share for the re vised MEI is 7.249 percent. For wage costs of non-physicia n, health-related workers, the survey question asks for the expenses for: “other clinical staff, includi ng RNs, LPNs, physicists, lab technicians, x-ray technicians, medical assistants, and other clinical personnel who cannot independently bill.” Using this method, the proposed non-physician, hea lth-related wage cost share for the revised MEI is 4.636 percent. Together the non-health and h ealth-related, non-physician wage costs sum to be equal to the total n on-physician wage share in the revised MEI of 11.885 percent. We further proposed to disaggregate the non-physician, non-health-re lated wage cost weight of 7.249 percent into four occupational subcategories. The methodology is similar to that

finalized in the CY 2011 PFS final rule with comm ent period (75 FR 73264), in that we are using

### CMS-1600-FC 136

2006 Current Population Survey (CPS) data and 2006 BLS Occupational Employment Statistics (OES) data to develop cost weights for wage s for non-physician, non-health-related occupational groups. We determined total annual earnings fo r offices of physicians using employment data from the CPS and mean annual earnings from the OES. To arrive at a distribution for these separate occupational categorie s (Professional & Related (P&R) workers, Managers, Clerical workers, and Service workers), we determined annual earnings for each using the Standard Occupational Classification (SOC) sy stem. We then determined the overall share of the total for each. The proposed occupational di stribution in the revised MEI is presented in Table 16. The comparison between the proposed revised dist ribution of non-physician payroll expense by occupational group to the prior comparison can be found in the CY 2014 PFS proposed rule at 78

FR43315.

TABLE 16: Percent Distribution of Non-physi cian Payroll Expense by Occupational Group: Revised 2006-Based MEI.

Revised MEI (2006=100), Revised Weight Revised Cost Category 16.553% Non-physician compensation 11.885% Non-physician wages 7.249% Non-health, non-phys. wages 0.800% Professional and Related 1.529% Management 4.720% Clerical 0.200% Services 4.636% Health related, non-phys. wages 4.668% Non-physician benefits The health-related workers were previously included mainly in the Professional and Technical and Service Categorie s. The proposed reclassifica tions allow for health-related workers to be proxied by a health-specific ECI rath er than an ECI for more general occupations.

### CMS-1600-FC 137

(b) Other Practice Expense: The remaining expenses in the MEI are categor ized as Other Practice Expenses. In the

current 2006-based MEI we had classified other PEs in one of the following subcategories: Office Expenses; Drugs and Supplies; and All Other Professional Expenses. For CY 2014, we proposed to disaggregate these expenses in a way consistent with the MEI-TAP’s recommendations, as detailed below. We rely on the 2006 AMA PPIS data to determine the cost share for Other Practice Expenses. These expenses are the total of offi ce expenses, medical supplies, medical equipment, Professional Liability Insurance (PLI), and all other professional expenses. For the revised 2006-based MEI, we disaggr egate Other Practice Expenses into 15 detailed subcategories as shown in Table 17.

TABLE 17: Revised Cost Categor ies for Other Practice Expense Revised Cost Category Revised Weight Other Practice Expense 32.581% Utilities 1.266% Miscellaneous Office Expenses 2.478% Chemicals 0.723% Paper 0.656% Rubber & Plastics 0.598% All other products 0.500% Telephone 1.501% Postage 0.898% All Other professional services 8.095% Professional, Sc ientific, and Tech. Services 2.592% Administrative support & waste mgmt 3.052% All Other Services 2.451% Capital 10.310% Fixed 8.957% Moveable 1.353% Professional Liability Insurance 4.295% Medical Equipment 1.978% Medical supplies 1.760%

### CMS-1600-FC 138

For most of these categories, we use the same method as finalized in the CY 2011 PFS final rule with comment period to estimate the cost shares. In particular, the cost shares for the following categories are derived directly from expense data reported on the 2006 AMA PPIS: PLI; Medical Equipment; and Medical Supplies. In each case, the cost shares remain the same as in the current MEI. Additionally, we continue to use the Bureau of Economic Analysis (BEA) 2002–Benchmark I/O data aged to 2006 to determ ine the cost weights fo r other expenses not collected directly from the AMA PPIS. The BEA 2002-Benchmark I/O data can be accessed at the following link: http://www.bea.gov/industr y/io_benchmark.htm#2002data 

### The derivation of the cost weight for each of the detailed categor ies under Other Practice Expenses is provided in 78 FR 43315-43316. The following categories had no revisions proposed to the cost share weight and therefore reflect the same cost share weight as finalized in the CY 2011 final rule: Utilities, Telephone, Postag e, Fixed Capital, Moveable Capital, PLI, Medical Equipment, and Medical Supplies. Th e following section provides a review of the categories for which we proposed revisions to the cost categories a nd cost share weights (Miscellaneous Office Expenses, and All Other Services).

● Miscellaneous Office Expenses : Based on MEI-TAP recommendation 3.4 we proposed to include an aggregat e category of detailed office expe nses that were stand-alone categories in the current 2006-based MEI. During the CY 2011 PFS proposed rule comment period, several commenters expressed confusion as to the relevance of th ese categories to their practice costs. The MEI-TAP discussed the degree of granularity needed in both the calculation and reporting of the MEI. The MEI-TAP concluded that it might be prudent to collapse some of the non-labor PE categories with other categories for presentation purposes.

### CMS-1600-FC 139

● All Other Professional Services : Based on MEI-TAP recommendation 3.3, we proposed to combine the All Other Services cost weight and All Other Professional Expenses into a single cost category. The proposed wei ght for the All Other Professional Services category is 8.095 percent, which is the sum of the current MEI weight for All Other Services (3.581 percent) and All Other Professional Expenses (4.513 percent), and is more in line with the

GPCI Purchased Services index as finalized in the CY2012 PFS final rule with comment period (76 FR 73085). - We then proposed to further disaggregate th e 8.095 percent of expenses into more detail based on the BEA I-O data, allowing for specific co st weights for services such as contract billing services, accounting, and lega l services. We considered va rious levels of aggregation; however, in considering the leve l of aggregation, the availabl e corresponding price proxies had to be considered. Given the pr ice proxies that are available from the BLS Employment Cost Indexes (ECI), we proposed to disaggregate these expenses into three categories:

● NAICS 54 (Professional, Scien tific, and Technical Services) : The Professional, Scientific, and Technical Services sector comprises establishments that specialize in performing professional, scientific, and techni cal activities for others. These activities require a high degree of expertise and training. The establishments in this sector specialize according to expertise and provide these services to client s in a variety of industries, in cluding but not limited to: legal advice and representation; accoun ting, and payroll se rvices; computer services; management consulting services; and advertising se rvices and have a 2.592 percent weight.

● NAICS 56 (Administrative and Support and Waste Management and Remediation Services) : The Administrative and Support and Wast e Management and Remediation Services sector comprises establishments performing routine support activities for the day-to-day

### CMS-1600-FC 140

operations of other organizations. The establishments in this sector specia lize in one or more of these support activities and provide these services to clients in a variety of industries including but not limited to: office administration; tempor ary help services; secur ity services; cleaning and janitorial services; and trash co llection services. Th ese services have a 3.052 percent weight.

● All Other Services, a resi dual category of these expenses : The residual All Other Services cost category is mostly comprised of expenses associated wi th service occupations, including but not limited to: lab and blood sp ecimen transport; cater ing and food services; collection company services; a nd dry cleaning services and have a 2.451 percent weight.

2. Selection of Price Proxies for Use in the MEI After developing the cost category weights fo r the revised 2006-base d MEI, we reviewed all the price proxies based on th e recommendations from the MEI-TAP. As was the case in the development of the current 2006-based MEI, most of the proxy measures we considered are based on BLS data and are grouped into one of the following four categories:

● Producer Price Indices (PPIs) : PPIs measure price changes for goods sold in markets other than retail markets. These fixed-weight indexes are measures of price change at the intermediate or final stage of production. They are the preferred proxies for physician purchases as these prices appropriate ly reflect the product’s firs t commercial transaction.

● Consumer Price Indices (CPIs) : CPIs measure change in the prices of final goods and services bought by consumers. Like the PPIs, they are fixed weight indexe s. Since they may not represent the price changes faced by producers, CPIs are used if there are no appropriate PPIs or if the particular expenditure category is likely to contain purchases made at the final point of

sale.

### CMS-1600-FC 141

● Employment Cost Indices (ECIs) for Wages & Salaries : These ECIs measure the rate of change in employee wage rates per hour worke d. These fixed-weight in dexes are not affected by employment shifts among industries or occupati ons and thus, measure only the pure rate of change in wages.

● Employment Cost Indices (ECIs) for Employee Benefits : These ECIs measure the rate of change in employer costs of employee benefi ts, such as the employer’s share of Social Security taxes, pension and other retirement plans, insurance benef its (life, health, disability, and accident), and paid leave. Like ECIs for wage s & salaries, the ECIs fo r employee benefits are not affected by employment shifts among industries or occupations. When choosing wage and price proxies for each expense category, we evaluate the strengths and weaknesses of each proxy vari able using the following four criteria.

● Relevance : The price proxy should appropriately re present price changes for specific goods or services within the expense categor y. Relevance may encompass judgments about relative efficiency of the market ge nerating the price and wage increases.

● Reliability : If the potential proxy demonstrates a high sampling variability, or inexplicable erratic patterns ove r time, its viability as an appropriate price proxy is greatly diminished. Notably, low sampling variability can conflict with relevance—since the more specifically a price variable is defined (in terms of service, co mmodity, or geographic area), the higher the possibility of high sa mpling variability. A well-esta blished time series is also preferred.

● Timeliness of actual published data : For greater granularity and the need to be as timely as possible, we prefer monthly and quarterly data to annual data.

### CMS-1600-FC 142

● Public availability : For transparency, we prefer to us e data sources that are publicly

available. The price proxy selection for every category in the proposed revised MEI is detailed in 78 FR 43316-43319. Below we discuss the price and wage proxies for each cost category in the proposed revised MEI. a. Physician Compensation (Physician’s Own Time) (1) Physician Wages and Salaries Based on recommendations from the MEI-TAP, we proposed to use the ECI for Wages and Salaries for Professional and Related Occupa tions (Private Industry) (BLS series code CIU2020000120000I) to measure price growth of this category in the revi sed 2006-based MEI. The current 2006-based MEI used Average Hour ly Earnings (AHE) for Production and NonSupervisory Employees for th e Private Nonfarm Economy.

The MEI-TAP had two recommendations concerning the price proxy for physician Wages and Salaries. The first recommenda tion from the MEI-TAP was Recommendation 4.1, which stated that: “...OACT revise the price proxy associated with Physician Wages and Salaries from an Average Hourly Earnings concept to an Employment Cost Index concept.” AHEs are calculated by dividing gross payrolls for wages and salaries by total hours. The AHE proxy was representative of actual changes in hourly earnings for the nonfarm business economy, including shifts in employment mix. Th e recommended alternative, the ECI concept, measures the rate of change in employee wage rates per hour worked. ECIs measure the pure rate of change in wages by industry and/or occupation and are not a ffected by shifts in employment mix across industries and occupati ons. The MEI-TAP believed that the ECI concept better reflected physician wage trends compared to the AHE concept.

### CMS-1600-FC 143

The second recommendation related to the pr ice proxy for physician wages and salaries was Recommendation 4.2, which stated that: “CMS revise the price proxy associated with changes in Physician Wages and Salaries to use the Employment Cost Index for Wages and Salaries, Professional and Related, Private Industry. The Panel believes this change would maintain consistency with the guidance provided in the 1972 Senate Finance Committee report titl ed ‘Social Security Amendments of 1972,’

which stated that the index should reflect changes in practice expens es and ‘general earnings.’ In the event this change would be determined not to meet the legal requirement that the index reflect “general earnings,” th e Panel recommended replacing the current proxy with the Employment Cost Index for Wages and Salaries, All Workers, Private Industry.” The Panel believed this change would maintain consistency with the guidance provided in the 1972 Senate Finance Committee report titled “Social Security Amendments of 1972,” which stated that the index should reflect changes in prac tice expenses and “general earnings.” 2 

### We agree that switching the proxy to the ECI for Wages and Salaries for Professional and Related Occupations would be consistent with th e authority provided in th e statute and reflect a wage trend more consistent with other prof essionals that receive advanced training. Additionally, we believe the ECI is a more a ppropriate concept than the AHE because it can isolate wage trends without being impacted by the change in the mix of employment. (2) Physician Benefits

The MEI-TAP states in Recommendation 4.3 th at, “...any change in the price proxy for Physician Wages and Salaries be accompanied by the selection and incorporation of a Physician Benefits price proxy that is cons istent with the Physician Wages and Salaries price proxy.” We

2 U.S. Senate, Committee on Finance, Social Security Amendments of 1972 . ‘‘Report of the Committee on Finance United States Senate to Accompany H.R. 1,’’ September 26, 1972, p. 191.

### CMS-1600-FC 144

proposed to use the ECI for Benefits for Professi onal and Related Occupations (Private Industry) to measure price growth of this category in the revi sed 2006-based MEI. The ECI for Benefits for Professional and Related Occupations is derived using BLS’s Total Compensation for Professional and Related Occupations (BLS series ID CIU2010000120000I) and the relative importance of wages and salaries wi thin total compensation. We belie ve this series is technically appropriate because it better reflects the benef it trends for professionals requiring advanced training. The current 2006-based MEI market bask et used the ECI for Total Benefits for the Total Private Industry. b. Practice Expense (1) Non-Physician Employee Compensation (a) Non-Physician Wages and Salaries (i) Non-Physician, Non-Health-Related Wages and Salaries

● Professional and Related : We proposed to continue using the ECI for Wages and

Salaries for Professional and Related Occupation (Private In dustry) (BLS series code CIU2020000120000I) to measure the price grow th of this cost category.

● Management : We proposed to continue using the ECI for Wages and Salaries for Management, Business, and Financial (Priva te Industry) (BLS series code CIU2020000110000I) to measure the price growth of this cost category.

● Clerical : We proposed to continue using the ECI for Wages and Salaries for Office and Administrative Support (Private Indus try) (BLS series code CIU2020000220000I) to measure the price growth of this cost category. This is the same proxy used in the current 2006-

based MEI.

### CMS-1600-FC 145

● Services : We proposed to continue using the ECI for Wages and Salaries for Service Occupations (Private Indust ry) (BLS series code CIU 2020000300000I) to measure the price growth of this cost category. (ii) Non-physician, Health-R elated Wages and Salaries In Recommendation 4.4, the MEI-TAP “...r ecommend[ed] the disaggregation of the Non-Physician Compensation costs to include an additional categor y for health-related workers. This disaggregation would allow for health-rela ted workers to be separated from non-healthrelated workers. CMS should rely directly on PPIS data to estimate the health-related nonphysician compensation cost weights. The non- health, non-physician wages should be further disaggregated based on the Current Population Su rvey and Occupational Employment Statistics data. The new health-related cost category shou ld be proxied by the ECI, Wages and Salaries, Hospital (NAICS 622), which has an occupational mix that is reasonably close to that in physicians’ offices. The Non-Physician Benef it category should be proxied by a composite benefit index reflecting the same relative occupa tion weights as the non-physician wages.” We proposed to use the ECI for Wages and Salaries for Hospital Workers (Private Industry) (BLS series code CIU2026220000000I) to measure the price gr owth of this cost category in the final revised 2006-based MEI. The ECI for Hospita l workers has an occupational mix that approximates that in physicians’ offices. This co st category was not broken out separately in the

current 2006-based MEI. (b) Non-Physician Benefits We proposed to continue using a composite ECI for non-physician employee benefits in the revised 2006-based MEI. However, we also proposed to expand the number of occupations from four to five by adding detail on Non-Physic ian Health-Related Benefits. The weights and

### CMS-1600-FC 146

price proxies for the composite benefits index w ill be revised to reflect the addition of the new category. Table 18 lists the five ECI series a nd corresponding weights us ed to construct the revised composite benefit index for non-physicia n employees in the revised 2006-based MEI.

TABLE 18: CMS Composite Price Index for Non-physician Employee Benefits in the Revised 2006-Based MEI

ECI Series 2006 Weight (%) Benefits for Professiona l and Related Occupation (Private Industry) 7 Benefits for Management, Business, and Financial (Private Industry) 12

Benefits for Office and Administrative Support (Private Industry) 40 Benefits for Service Occupations (Private Industry) 2 Benefits for Hospital Workers (Private Industry) 39 (3) Other Practice Expense (a) All Other Professional Services As discussed previously, MEI-T AP Recommendation 3.3 was that: “...OACT create a new cost categor y entitled Professional Servic es that should consist of

the All Other Services cost category (and its respective weig ht) and the Other Professional Expenses cost category (and its respective weight). The Panel further recommends that this category be disaggregated into appropriate occupa tional categories consistent with the relevant price proxies.” We are proposed to implemen t this recommendation in the revised 2006-based MEI using a cost category titled “All Other Pr ofessional Services.” Likewise, the MEI-TAP

stated in Recommendation 4.7 that “...price changes associated w ith the Professional Services category be proxied by an appropria te blend of Employment Cost Indexes that reflect the types of professional services purchased by physician offices.” We agree with this recommendation

### CMS-1600-FC 147

and proposed to use the following price proxies for each of the new occupational categories:

● Professional, Scientif ic, and Technical Services : We proposed to use the ECI for Total Compensation for Professional, Scientific, and Tec hnical Services (Private Industry) (BLS series code CIU2015400000000I) to measure the price growth of this cost category. This cost category was not broken out separately in the current 2006-based MEI.

● Administrative and Support Services : We proposed to use the ECI for Total Compensation for Administrative, Support, Wa ste Management, and Remediation Services (Private Industry) (BLS series code CIU 2015600000000I) to measure the price growth of this cost category. This cost category was not broken out separately in the current 2006-based MEI.

● All Other Services : We proposed to use the EC I for Compensation for Service Occupations (Private Indust ry) (BLS series code CIU 2010000300000I) to measure the price growth of this cost category. (b) Miscellaneous Office Expenses

● Chemicals : We proposed to continue using th e PPI for Other Basic Organic Chemical Manufacturing (BLS series code #PCU32519–32519) to measure the price growth of this cost category.

● Paper : We proposed to continue using the PPI for Converted Paper and Paperboard (BLS series code #WPU0915) to measure the price growth of this cost category.

● Rubber & Plastics : We proposed to continue using the PPI for Rubber and Plastic Products (BLS series code #WPU07) to measure the price growth of this cost category.

● All Other Products : We proposed to continue usi ng the CPI-U for All Products less Food and Energy (BLS series code CUUR0000SA0L1E) to measure the price growth of this cost category.

### CMS-1600-FC 148

● Utilities : We proposed to continue using the CP I for Fuel and Utilities (BLS series code CUUR0000SAH2) to measure the price growth of this cost category.

● Telephone : We proposed to continue using the CPI for Telephone Services (BLS series code CUUR0000SEED) to measure the price growth of this cost category.

● Postage : We proposed to continue using th e CPI for Postage (BLS series code CUUR0000SEEC01) to measure the price growth of this cost category.

● Fixed Capital : In Recommendation 4.5, “The Panel recommends using the Producer

Price Index for Lessors of Nonresidential Build ings (NAICS 53112) for the MEI Fixed Capital cost category as it repres ents the types of fixed capital expens es most likely faced by physicians. The MEI-TAP noted the volatility in the index, wh ich is greater than the Consumer Price Index for Owners’ Equivalent Rent of Residences. This relative vo latility merits ongoing monitoring

and evaluation of alternatives.” We are proposed to use the PPI for Lessors of Nonresidential Buildings (BLS series code PCU531120531120) to measure the price growth of this cost category in the revised 2006-based MEI. The cu rrent 2006-based MEI used the CPI for Owner’s Equivalent Rent. We believe the PPI for Le ssors of Nonresidential Buildings is more appropriate as fixed capital expe nses in physician offices should be more congruent with trends in business office space costs than residential costs.

● Moveable Capital: In Recommendation 4.6, the MEI-TAP states that “...CMS conduct research into and identify a more appropriate price proxy for Moveable Capital expenses. In particular, the MEI-TAP believes it is important that a proxy reflect price changes in the types of non-medical equi pment purchased in the producti on of physicians’ services, as well as the price changes associated with In formation and Communicatio n Technology expenses (including both hardware and software).” We in tend to continue to investigate possible data

### CMS-1600-FC 149

sources that could be used to proxy the physician expenses related to moveable capital in more detail. However, we proposed to continue us ing the PPI for Machinery and Equipment (series code WPU11) to measure the price growth of this cost category in the re vised 2006-based MEI.

● Professional Liability Insurance : Unlike the other price proxies based on data from BLS and other public sources, the proxy for PLI is based on data collected directly by CMS from a sample of commercial insurance carriers. The MEI-TAP discusse d the methodology of the CMS PLI index, as well as considered alternative data sources for the PLI price proxy, including information available from BLS and through st ate insurance commissioners. MEI-TAP Finding

4.3 states: “The Panel finds the CMS-constructed profession al liability insurance price index used to proxy changes in professional liability insuranc e premiums in the MEI represents the best currently available method for its intended purpose. The Panel also believes the pricing patterns of commercial carriers, as measured by the CM S PLI index, are influenced by the same driving forces as those observable in policies underwritt en by physician-owned insu rance entities; thus,

the Panel believes the current index appropriately reflects the price changes in premiums throughout the industry.” Given this MEI-TAP fi nding, we proposed to continue using the CMS Physician PLI index to measure the price growth of this cost category in the revised 2006-based

MEI.

● Medical Equipment : We proposed to continue usi ng the PPI for Medical Instruments and Equipment (BLS series code WPU1562) as the price proxy for this category.

● Medical Materials and Supplies : We proposed to continue using a blended index comprised of a 50/50 blend of the PPI for Surg ical Appliances (BLS series code WPU156301) and the CPI–U for Medical Equipment and Supplies (BLS series code CUUR0000SEMG).

### CMS-1600-FC 150

TABLE 19: Revised 2006-Based MEI Cost Categories, Weights, and Price Proxies Cost Category 2006 Weight Price Proxy Total MEI 100.000% Physician Compensation 50.866% Wages and Salaries 43.641% ECI - Wa ges and salaries - Professional and Related (Private) Benefits 7.225% ECI - Benefits - Professional and Related (Private) Practice Expense 49.134% Non-physician Compensation 16.553% Non-physician Wages 11.885%Non-health, nonphysician wages 7.249%

Professional and Related 0.800% ECI - Wages And Salaries - Professional and Related (Private) Management 1.529% ECI - Wages And Salaries - Management, Business, and Financial (Private) Clerical 4.720% ECI - Wages And Salaries - Office and Admin. Support (Private) Services 0.200% ECI - Wa ges And Salaries - Service Occupations (Private) Health related, non-phys. Wages 4.636% ECI - Wages and Salaries - Hospital (Private) Non-physician Benefits 4.668% Composite Benefit Index Other Practice Expense 32.581% Miscellaneous Office Expenses 2.478%

Chemicals 0.723% PPI - Other Basic Organic Chemical Manufacturing Paper 0.656% PPI - Converted Paper and Paperboard Rubber and Plastics 0.598% PPI - Rubber and Plastic Products All other products 0.500% CPI - All Items Less Food And Energy Telephone 1.501% CPI - Telephone Postage 0.898% CPI - Postage All Other Professional Services 8.095%

Prof., Scientific, and 2.592% ECI - Compensation - Prof., Scientific, and

### CMS-1600-FC 151

Cost Category 2006 Weight Price Proxy Tech. Svcs. Technical (Private) Admin. and Support Services 3.052% ECI - Compensation - Admin., Support, Waste Management (Private) All Other Services 2.451% ECI - Compensation - Service Occupations (Private) Capital Fixed Capital 8.957% PPI - Lessors of Nonresidential Buildings Moveable Capital 1.353% PPI - Machinery and Equipment Professional Liability Insurance 4.295% CMS - Professional Liability Phys. Prem. Survey Medical Equipment 1.978% PPI - Medical Instruments and Equipment Medical Supplies 1.760% Composite - PPI Surgical Appliances & CPI-U Medical Supplies 3. Productivity Adjustment to the MEI The MEI has been adjusted for changes in pr oductivity since its inception. In the CY 2003 PFS final rule with comment period (67 FR 80019), we implemented a change in the way the MEI was adjusted to account for changes in productivity. The MEI used for the 2003 physician payment update incorporated changes in the 10-year moving average of private nonfarm business (economy-wide) mu ltifactor productivity that were applied to the entire index. Previously, the index incorporated changes in pr oductivity by adjusting the labor portions of the index by the 10-year moving average of ec onomy-wide private nonf arm business labor productivity. The MEI-TAP was asked to review this approa ch. In Finding 5.1, “[t]he Panel reviewed the basis for the current economy-wide multifactor productivity adjustment (Private Nonfarm Business Multifactor Productivity) in the MEI and finds such an adjustment continues to be appropriate. This adjustment prevents ‘doubl e counting’ of the effects of productivity improvements, which would otherwise be reflecte d in both (i) the increase in compensation and other input price proxies underlying the MEI, and (ii) the gr owth in the number of physician

### CMS-1600-FC 152

services performed per unit of input resources, which results from advances in productivity by individual physician practices.” Based on the MEI-TAP’s finding, we proposed to continue to use the current method for adjusting the full MEI for multifactor productivity in the revised 2006-based MEI. As described in the CY 2003 PFS final rule with comment period, we believe this adjustment is appropriate because it explicitly reflect s the productivity gains associated with all inputs (both labor and nonlabor). We believe that using the 10-year moving average percent change in economy-wide multifactor productivity is appropriate for derivi ng a stable measure that helps alleviate the influence that the peak (or a trough) of a business cycle ma y have on the measure. The adjustment will be based on th e latest available historical economy-wide nonfarm business multifactor productivity data as measured and published by BLS. 4. Results of Revisions on the MEI Update Table 20 shows the average calendar year pe rcent change from CY 2005 to CY 2013 for

both the revised 2006-based MEI and the cu rrent 2006-based MEI, both excluding the productivity adjustment. The average annual pe rcent change in the re vised 2006-based MEI is 0.1 percent lower than the cu rrent 2006-based MEI over the 2005-2013 period. On an annual basis over this period, the differences vary by up to plus or minus 0.7 percentage point. In the two most recent years (CY 2012 and CY 2013), th e annual percent change in the revised 2006- based MEI was within 0.1 percenta ge point of the percent change in the current 2006-based MEI. The majority of these differences over the histori cal period can be attribut ed to the revised price proxy for physician wages and salaries and benefits and the revised price pr oxy for fixed capital.

### CMS-1600-FC 153

TABLE 20: Annual Percent Change in th e Revised 2006-Based MEI, not including productivity adjustment and the Current 2006-Based MEI, not including productivity adjustment * 

### Update Year Revised 2006-based MEI excl. MFP Current 2006- based MEI, excl. MFP CY 2005 3.8 3.1 CY 2006 4.0 3.3 CY 2007 3.2 3.2 CY 2008 3.2 3.4 CY 2009 2.9 3.1 CY 2010 2.4 2.8 CY 2011 0.9 1.6 CY 2012 1.7 1.8 CY 2013 1.7 1.8 Avg. Change for CYs 2005-2013 2.6 2.7 * Update year based on historical data through the sec ond quarter of the prior calen dar year. For example, the 2014 update is based on historical data through the second quarter 2013, prior to the MFP adjustment



### 5. Summary of Comments and the Associated Responses

Comment : Many commenters appreciate the efforts of CMS to implement the recommendations of the MEI-TAP. They agree with the MEI-TAP’s analysis and recommendations and believe these changes suc cessfully bring the “m arket basket” of MEI inputs up to date and improve the accuracy of the index going fo rward. Nearly all commenters supported the following proposals:

● The increase in the physicia n benefits cost weight in orde r to ensure consistency with the benefits price proxy.

● The use of professional workers’ earni ngs as the price proxy for the physician compensation portion of the index. Specifically, the price proxies for physician wages would change from general economy-w ide earnings to a wages index for “Professional and related occupations” and the price proxy for physician benefits would be changed from general economy-wide benefits to a benefit index for “Professional and related occupations.”

### CMS-1600-FC 154

● The use of commercial rent data for th e fixed capital price proxy, replacing the CPI residential rent proxy.

● The creation of a health sector wage category with in the index.

● The creation of an “all ot her professional serv ices” category, encompassing purchased

services such as contract billi ng, legal, and accounting services. Response : We agree with the commenters that implementing the TAP recommendations identified above improve the accuracy of the index.

Comment : Several commenters concur with the proposal to reclassify expenses for nonphysician clinical personnel that can bill i ndependently from non-physician compensation to physician compensation. They agree with the pr oposal based on the reasons CMS outlines and because this policy is more consistent with how services by non-physic ian practitioners are

treated in the resource-based relative value scale (RBRVS). Response : We appreciate the commen ters support for the decisi on to reclassify expenses related to non-physician clinical personnel th at can bill independently from non-physician compensation to physician compensation. We also agree with the commenter that classifying the expenses with physician compensation is more consistent with how services by non-physician practitioners are treated in the RBRVS since serv ices related to direct patient care from nonphysician practitioners are report ed with the work component in the RBRVS methodology. We also believe that non-phy sician practitioners will continue to perform se rvices that are direct substitutes for services furnished by physicians, such as office visits.

Comment : Many commenters believe that it is not technically appropriate to reclassify all expenses for non-physician clinical personnel that can bill independe ntly from non-physician compensation to physician compensation. They note that the MEI-TAP recommended that the

### CMS-1600-FC 155

OACT consider “the extent to which those who can bill independently actually do so.” They also note that non-physician clinical personnel ofte n spend much of their time on activities other than providing services that are billed independen tly. They suggested that only the portion of the time the non-physician clinical pers onnel spend providing services th at are billed independently should be reclassified to physicia n compensation. They believe th at the increase in the physician compensation cost share by 2.600 percentage points, and the reduc tion in non-physician compensation by the same amount, is too high. The commenters encourage CMS to conduct real analysis of the time spent on activ ities that are billed independen tly prior to implementing this

re-allocation of costs. Response : We understand that non-physician clini cal personnel may spend some of their time on activities other than providing services that are billed indepe ndently. We would note that physicians also spend some of their time on work that is not direct patient care. We proposed to only reclassify the expenses related to the non-physician clinical personnel that can bill independently; that is, we are not reclassi fying the expenses for non-physician clinical personnel that cannot bill indepe ndently. We believe that the increase in physician compensation is technically correct. The commenters suggested that the non-phys ician clinical staff that can bill independently spend much of their time on activities other than providing services that are billed separately; however, the commenters did not provid e any evidence to support this claim. Based on part B claims data we have found that nu rse practitioners and physician assistants bill Medicare for the same top HCPCS codes as other primary care sp ecialties, including office/outpatient visits, subsequent hospital ca re, emergency department visits, and nursing facility care subsequent visits. Based on this, we do not believe further analysis is needed to

### CMS-1600-FC 156

conclude that the non-physician practitioners that can bill independently are furnishing services that are substitutes for services furnished by physicia ns. As such, we continue to believe that it is appropriate to classify their costs in the physicia n compensation category.

Comment: A few commenters suggested that multiple states preclude non-physicians from practicing and billing independ ently and therefore the reclassi fication of expenses for these services would affect those states differently than the states where non-physician practitioners are allowed to practice and bill independently. Response : We understand that state laws govern ing the practice rules for non-physician practitioners can vary by State; however, we do not believe that this is relevant to the decision to include in the physician compensa tion cost category the expenses for non-physician practitioners that can independently bill under Medicare. Th ese expenses were collected on the AMA PPIS where we expect that physicians would have repo rted the expenses that coincided with the state laws for non-physician clinical staff for the state in which they practiced. For a state in which the laws do not permit non-physicia n practitioners to bill indepe ndently, the expenses would have been allocated to the category for clinic al staff that cannot bill independently.

Comment : Several commenters questioned the implementation of the MEI-TAP recommendation concerning payroll for non-physician personnel. The commenters stated that

the recommendation was more nuanced than we had conveyed and that it only directed CMS to evaluate making the change. The commenters su ggested that the recommendation required CMS

to consider several factors includ ing but not limited to, the statut ory definition of “physician” as it relates to the recommended change; how tim e for non-physician practitioners is currently treated in the PFS RVU methodology; whethe r there is evidence these non-physician

### CMS-1600-FC 157

practitioners do not spend the majority of thei r time providing “physicians’ services;” and the extent to which these practitioners actually do bi ll independently for the services they furnish. Response : When evaluating the MEI-TAP re commendation 3.2 and formulating our proposal, we did consider the specific factors that the MEI-TAP included in the recommendation to reclassify the expenses related to non-phys ician clinical staff th at can bill Medicare independently. However, we disagree with the commenters’ interpretation that the recommendation intended CMS to only evaluate ma king the change. We believe that the intent

of all of the recommendations of the MEI-TAP was for CMS to evaluate the recommendations and propose and implement those changes as soon as possible. As we indicated in the proposed rule, ther e are several reasons for our proposal to reclassify these expenses which were: (1) these types of practitioners fu rnish services that are similar to those furnished by physicians; (2) if bi lling independently, these practitioners would be paid at a percentage of the physicians’ services or in certain cases at the same rate as physicians; and (3) the expenses related to the work components for the RVUs would include work from

clinical staff that can bill independently. Therefore, it w ould improve consistency with the RVU payments to include these expenses as physician compensation in the MEI. In response to this comment, we explain furt her our consideration of each of the factors

as follows: First, we do not believe the de finition of physician under curre nt law limits CMS’ ability to make the proposed change in the MEI. No pr ovisions of the Social Se curity Act address the classification of costs in the MEI. The goal of th e MEI is to appropriately estimate the change in the input prices of the goods and services used to furnish physician services over time. Therefore, we believe that cla ssifying costs for those non-physician practitioners that can bill

### CMS-1600-FC 158

independently with physician compensation is th e most technically appropriate classification, given their role in the healthca re delivery system today. We believe that since non-physician practitioners (NPPs) who bill independently furnis h services that substitute for physician work and that the salary costs for thes e types of providers would grow at a similar rate to those of physicians, it is appropriate to classify th ese expenses within the physician compensation component of the MEI. Second, the expenses for non-physician practit ioners that can independently bill are reflected in the physician work component in the PFS RVU methodology since their services are substituting for physician work. Expenses for other clinical staff, including RNs, LPNs, physicists, lab technicians, x-ra y technicians, medical assistan ts, and other clinical personnel who cannot independently bill are reported in the PE component in the RVU methodology. Third, we have found no evidence that these t ypes of providers do not spend the majority of their time performing “physicians’ services ,” as defined under the PFS. We looked at 2012 claims data for the nurse practit ioners (NPs) (specialty code 50) and physician assistants (PAs) (specialty code 97) and compared their top Pa rt B HCPCS codes reported on claims to the top Part B HCPCS codes reported on claims of the following three physician specialties: General Practice (specialty code 01), Family Practice (specialty code 08), a nd Internal Medicine (specialty code 11). We found that 7 out of the 10 top HCPC S codes for PAs and NPs are the same as those reported for physicians in Genera l Practice, Family Practice, and/or Internal

Medicine. HCPCS code 99213 and 99214 (both codes for office/outpa tient visits) were the top two HCPCS codes for all five specialties listed. Approximately 40 percent of claims for PAs and 50 percent of claims for NPs were for HCPCS code s that were also submitted by one of the three primary care specialties (general practice, family practice, and internal medicine). Based on this

### CMS-1600-FC 159

Medicare claims analysis, we believe that thes e types of non-physician pract itioners do spend the majority of their time performing “physicians’ services.” Fourth, we believe that non-physician practit ioners who are able to bill independently actually do so in the majority of circumstances wh ere it is financially bene ficial for the practice

as a whole. We understand that different states may have di fferent rules on how non-physician practitioners are permitted to furnish physician se rvices; but, in general, if the non-physician practitioner can independently bill, particularly if the reimbursement for the service is similar to or the same as that provided to a physician, th ey usually do so. We reviewed data on mean annual wages published in the May 2012 O ccupational Employment Survey (OES) ( http://www.bls.gov/oes/current/oes_stru.htm 

### ), and found that wages for PAs and NPs are significantly higher than RNs a nd LPNs / LVNs. Specifically, the mean annual wages for OES Category 29-1071 “Physician Assistants” is $92,460 and for OES Category 29-1171 “Nurse Practitioners” it is $91,450 whereas for OES Cate gory 29-1141 “Registered Nurses” it is $67,930 and for OES Category 29-2061 “Licensed Practi cal and Licensed Vocat ional Nurses” it is $42,400. In addition, wages for PAs and NPs are also significantly higher than technologist and technician wages. Select t echnologist and technician wages are OES Category 29-2051 “Dietetic Technicians” at $28,680, OES Category 29-2052 “Pharmacy Technicians” at $30,430, OES Category 29-2053 “Psychiatric Technicians” at $33,140, OES Category 29-2054 “Respiratory Therapy Technicians” $47,510, and OES Cate gory 29-2055 “Surgical Te chnologists” at $43,480. Given the significantly higher wa ges for PAs and NPs, we believe it makes economic sense for PAs and NPs to furnish and bill for “physicians’ services” to the extent permitted by law rather

than to serve as clinical staff members who only furnish services incident to a physician’s

services.

### CMS-1600-FC 160

Comment : One commenter believes that the MEI is intended to be a reflection of physician compensation and physician expenses, and that it must conform to the definitions of “physician” and “physicians’ services,” which incl udes affirmation of the distinct definitions of physician and nurse practitioner. The commente r claims the reasons for our proposal fail to

account for this foundational distinction between physicians and “physic ians’ services” as opposed to other types of practitioners and their se rvices. The commenter be lieves that to lump the two definitions together, which is what we are doing, is not justifiable and in excess of authority. Response : We disagree with the commenter that classifying the non-physician independent billers’ expenses in the same category as the physic ian expenses “is not justifiable and in excess of authority.” The definition of physician that exists und er current law does not limit CMS’ ability to make this change in the ME I. As mentioned previously, no provisions of the Social Security Act address th e classification of costs in the MEI. We believe that since nonphysician practitioners that bill independently serve as substitu tes for physician work, and the growth in the salary costs for th ese types of providers would grow at a similar rate to physicians, then classifying the expenses related to non-physic ian practitioners that bill independently with physician compensation is the most technically appropriate classifi cation, given their role in the healthcare delivery system today.

Comment : It is unclear to several commenter s why the productivity assumptions for physicians are twice that used for the hospita l outpatient department and ambulatory surgery centers. Although they understood that these are tw o different calculations, they found it hard to imagine that individual physicians would have twice the capability of increasing productivity than would facilities. They note that all of the productivity adjustments should be based on 10-

### CMS-1600-FC 161

year averages of private non-farm business multifactor productivity growth, but the OPPS and ASC adjustments, are about half the MEI adjustment for CY 2014. Response : The productivity adjustments included in the MEI and those that apply to ASCs and HOPDs are based on the 10-year m oving average of economy-wide private nonfarm business multifactor productivity (MFP). The differences in the MFP adjustments between the ASC and HOPD payment systems and the PFS ar e the result of diffe rences between the applicable statutes and the time period for which the adjustment is calculated. MEI updates have been based on the latest hist orical data at the time of rulemaking since its inception. For the CY 2014 rule, the propos ed MEI update of 0.7 percent includes an MFP adjustment of 0.9 percent, which is based on BL S data through 2011 that represents the latest

historical data available at the time of rulemaking. The proposed MFP adjustment is based on the 10-year moving average of annual MFP growth from 2002-2011; and we would note that the annual MFP growth over the 2002-2004 tim e period was historically high. The ASC and HOPD MFP adjustments, on the other hand, are required by law to be based on forecasts for the appropriate paymen t period, in this case through CY 2014. The forecasts of the MFP are completed by IHS Gl obal Insight, Inc. (IGI). Accordingly, the MFP adjustment applicable to ASCs and HOPDs is based on the 10-year moving average of annual MFP growth from 2005-2014. A complete descripti on of the methodology used to calculate the

MFP for the MEI can be found in the CY 2012 P FS final rule with comment period (76 FR 73300).

Comment : One commenter disagrees with CMS’ assessment that there is not a reliable, ongoing source of data from which to index cost data. CMS is currently basing the MEI on 2006 data yet it accepted and has now fully transi tioned the results of the Physician Practice

### CMS-1600-FC 162

Information Survey (PPIS) as of 2013. The da ta from PPIS was develo ped based on practice costs in 2008. They questioned why the data curre ntly available would be any less reliable than was used the previous three times that CMS rebase d the MEI. In fact, they claim that the PPIS

data should be more reliable. The commente r acknowledges that data developed by the MGMA are derived primarily from large urban and subur ban practices and do not adequately capture costs from small and solo practitioners who do not enjoy the same economies of scale and practice efficiencies afforded to larger groups . However, the commenter would support another updated survey of practice costs similar to PPIS that would also include any elements included within the MEI that were not pr eviously captured. The commente r suggests that if the time and resources are going to go into such a study, the su rvey should include and be used to update all physician practice expenses. Response : We believe the commenter misunderst ood our statement. We do believe the AMA PPIS is a reliable data source; however, the PPIS is not an ongoing data source that is published regularly, such as the IPPS, SNF, a nd HHA cost reports. The 2006 AMA PPIS data were used to determine nine expenditure wei ghts in the 2006-based MEI: physicians’ earnings, physicians’ benefits, employed physician payro ll, non-physician compensation, office expenses, PLI, medical equipment, medical supplies, and ot her professional expenses. It continues to be the data source used in the CY 2014 proposed revisi ons to the MEI. At this time, the AMA is no longer conducting the PPIS survey. We concur with the commenter’s points re garding the issues pe rtaining to the MGMA data and also appreciate the commenter’s suppor t of conducting another practice cost survey similar to the PPIS. We will be looking into viable options for updating the MEI cost weights going forward.

### CMS-1600-FC 163

Comment : Several commenters appreciated th e efforts by CMS to convene the MEITAP, and urged the agency to continue work on the remaining issues the MEI-TAP identified including consideration of whether: (1) using self-empl oyed physician data for the MEI cost weights continues to be the most appropriate approach; (2) additional data sources could allow more frequent updates to the MEI’ s cost categories and their respective weights; and (3) there is a more appropriate price proxy for Moveable Ca pital expenses. The commenter noted that CMS plans to continue to investigate these three is sues and the commenter looks forward to working

with CMS in that effort. Response : We will continue to investigate possi ble options for the three remaining MEITAP recommendations as they require additional research regarding possible data sources. Any further changes to the MEI, in response to MEI-TAP recommendations, will be made through future notice and comment rulemaking.

Comment : One commenter noted that although the MEI-TAP recommended a number of

data sources that could be considered to rebase the MEI, it was unable to identify a reliable, ongoing source of data to do so. The commenter r ecommended that CMS consider a sample cost reporting method rather than a survey similar to the American Medica l Association’s (AMA) Physician Practice Information Survey (PPIS) that took place between 2007 and 2008. The

commenter noted that the PPIS was extraordinar ily expensive for the AMA and was plagued by low response rates. In addition, the commenter not ed that the disputed PPIS results led to significant payment reductions for cardiology. The commenter notes that CMS is already considering efforts to establish a cost report fo r provider-based clinics. The commenter suggests that this effort could be coupled with a sample of private practice clin ics in order to better

measure the MEI.

### CMS-1600-FC 164

Response : We thank the commenter for the sugges tion. We will be investigating possible data sources to use for the purpos e of rebasing the MEI in the futu re. Our research will include the evaluation of multiple potential data sources including a sampling of clinics and/or physicians subject to agency resource s. If reliable cost report data is collected for provider-based clinics in the future then we will analyze and co nsider its possible use at that time. We remind the commenter that any new study or survey we conduct would requir e approval through OMB’s standard survey and auditing pr ocess (see ‘‘Standards and Guidelines for Statistical Surveys’’ http://www.whitehouse.gov/sites/defau lt/files/omb/assets/omb/inforeg/statpolicy/standards_stat_surveys.p

df



### and ‘‘Guidance on Agency Survey and Statistical Information Collections’’ http://www.whitehouse.gov/sites/default/files/omb/ assets/omb/inforeg/pmc_survey_guidance_2006.pdf 

### ).

Comment : One commenter strongly supports the continued monitoring of physician productivity growth as it compares to economy-wi de growth. The commenter notes that medical practices have been subjected to a number of re gulatory requirements in recent years that likely impacted their productivity. To ensure co mpliance with these regulatory requirements, physicians often must take actions that reduce practice productivity, including hiring additional office staff, retaining attorneys for legal and regulatory compliance, and contracting with accountants and billing companie s to ensure proper processi ng of claims. Monitoring of physician productivity growth is necessary to de termine if the continued use of economy-wide productivity growth in the MEI is appropriate. Response : At the June 25, 2012 MEI-TAP meeting, we presented estimates of physicianspecific productivity from 1983 to 2010. These estimates used a resource-based methodology similar to that used by Charles Fisher to estimate physician office productivity from 1983-2004 as published in the Winter 2007 Health Care Financing Review. The MEI-TAP had the following finding regarding the physicia n-specific productivity estimates:

### CMS-1600-FC 165

Finding 5.2: The Panel finds the measures of growth in physician- specific productivity are of interest for the purpose of comparing the structure of pri ce increases for phys ician services versus other sectors of the economy. The Pane l does not recommend using a physician-specific measure, but does believe that continued monito ring is appropriate. Use of physician-specific productivity growth to adjust economy-wide co mpensation growth in the MEI could introduce

inconsistencies in the calculation of the MEI that could distort the result s. The Panel concludes it is appropriate to continue to require that th e accounting identity betw een input price growth, output price growth, and the produc tivity adjustment be maintained (as is approximated by the current version of the index). Per the MEI-TAP’s recommendation, we will co ntinue to monitor trends in physician productivity on a periodic basis and how thos e trends move relative to economy-wide productivity.

Comment : A few commenters noted that it will remain difficult for practicing clinicians to reconcile changes in the MEI w ith their own practice cost increases. The projected increase in the proposed MEI for 2014 is just 0.7 percent, but this amount has been reduced by economywide productivity growth of 0.9 percent. Exclud ing the productivity adjustment, inflation for medical practices is projected to be 1.6 percent for 2014. In addition, as is the case with any price index, this amount does not take into account any ch ange in the quantity of inputs (for example, changes in the number of sta ff that practices employ). Response : We believe the MEI is the most tec hnically appropriate index available to measure the price growth of inputs involved in fu rnishing physician services . We agree that the updates of the MEI do not take into account any cha nge in the quantity of inputs, since it is not a

cost index. The MEI-TAP was asked to consider whether the index should continue to be a

### CMS-1600-FC 166

fixed-weight, Laspeyres-type index. The MEI-T AP concluded that there is not sufficient evidence that the proportions of costs represen ted by the index’s inputs vary enough over short periods of time, nor was there a consistently upda ted data source available, to warrant or support a change from using the Laspeyres formulation.

Comment : One commenter believes that a driving flaw in the PE GPCI is the rent input and its weighting. The commenter indicates the proposed rule’s CY 2014 cost share weight of 10.223 percent is not representative of the office rent cost share weig hts of other physicians. It is also not representative of what the MGMA’s cost survey data seems to indicate is the national office rent cost weight. Response : As stated in the proposed rule, the PE GPCI office rent portion (10.223 percent) includes the revised 2006-based MEI cost weights for fixed capital (reflecting the expenses for rent, depreciation on medical buildin gs and mortgage interest) and utilities. The methodology for determining the fixed capital cost weight (8.957 percent) and utilities cost weight (1.266) is described in the CY 2011 PFS final rule (75 FR 73265). We believe the weights produced from the me thodology are technically appropriate as it is based on the 2006 AMA PPIS data and other g overnment data for NAICS 621A00 (Offices of physicians, dentists, and other hea lth practitioners). We realize that although individual practice experience may vary, the MEI cost shares must re flect the cost structure of the average physician

office.

Comment : One commenter supported the AM A’s call for MEI recognition of the cost/staffing implications of ever-increasing pr ivate and governmental regulations upon medical practices.

### CMS-1600-FC 167

Response : We believe the commenter is expressi ng that during the course of our future research into alternative data sources on physician expenses that we should try to find a data

source that would measure the in creased costs that re gulations compliance imposes on physicians practice expenses (for example, additional sta ffing or costs associated with moving to more technically advanced record-keeping such as electronic health records (EHRs)). If we are able to identify an appropriate data source for physic ian expenses that is updated and published on a regular basis, then the associated costs will be re flected in the relative shares of the various cost categories. In order to determine cost shares for a year later than 2006 we would need an

alternative data source that is re liable, representative, and collec ted on a more consistent, regular

basis.

Comment : One commenter claimed that the BE A Input-Output (I-O) tables categorize cost components differently than do medical pr actices; that CMS’ actua rial conclusions are difficult to follow; and the industr y wide I-O tables do not appear to comport with MGMA cost survey findings for medical practices. The comm enter also stated that BEA I-O tables seem more focused on and designed to address how th e offices of healthcare professionals utilize products in various national i ndustries for purposes of assess ing the productivity of those industries rather than to measure cost component s of a medical practice. In that regard, the

commenter asserts that the use of the I-O tables in developing GPCI cost share weights seems not to be an apples-t o-apples relationship. Response : We disagree with the commenter’s cl aim that the BEA I-O tables are only to be used for purposes of assessing productivity of those industries rather than to measure cost components. As stated on the BEA website ( http://www.bea.gov/scb/pdf/2007/ 10%20October/1007_be nchmark_io.pdf 

### ), the BEA I-O data are

### CMS-1600-FC 168

based on the highest quality source data available. They provide an accurate and comprehensive picture of the inner workings of the econom y, showing relationships among more than 400 industries and commodities. They facilitate the study of economic activity by providing a highly-detailed look at in ter-industry activity. They also provide the deta il that is essential in determining the quantity weights for price indexe s such as the producer price index that is compiled by the Bureau of Labor Statistics (BLS). Therefore, our use of the BEA I-O data to derive the detailed cost weight s for the MEI (and by extension th e GPCI weights) is consistent with definition of and uses of the I-O data, as stated by BEA.

We would also note that CMS’ examination of the MGMA cost data requested by the MEI-TAP found that the data: (1) reflected only group practice data (practices with greater than three physicians) rather than data for self-employed physician prac tices; (2) reflected more IDS and hospital-owned practices than physician- owned practices; (3) ar e not geographically representative; they are underrepres ented in high-cost areas (NY, NJ, CA) and overrepresented in lower cost areas, such as the southern U.S.; a nd (4) are skewed toward primary care specialties relative to the universe of physician specialties . Additionally, the MGMA data are not publicly available. The BEA I-O data, on the other hand are based on detailed data from the quinquennial economic censuses that are conducted by the Bur eau of the Census and show how industries

interact at the detaile d level; specifically, they show how approximately 500 industries provide input to, and use output from, each other to produ ce gross domestic product. The data we used in the construction of the MEI are representative of the entire broader industry as defined by NAICS 621A00, Offices of Physicians, Dentists and Other Health Professionals; and therefore we believe it is the most technically appropr iate data source available to use to further disaggregate practice expenses within the MEI.

### CMS-1600-FC 169

Comment : One commenter is concerned with CMS’ proposal to use the Employment Cost Index (ECI) for Wages and Salaries for Ho spital Workers (Private Industry) as a price proxy for Non-physician, Health-related staff compensation. The commenter does not agree with CMS’ reasoning that the ECI for Hospital Workers has an occupational mix that is reasonably close to the occupational mix in physicia ns’ offices. The commenter stated that they do not currently have an alte rnative price proxy suggestion. Response : The purpose of the disaggregation of the Non-Physician Compensation costs to include an additional category for health-relate d workers was to be able to more accurately reflect the price inflation associated with these workers. There are limited health-related ECIs available. During the MEI-TAP discussions on July 11, 2012, this limitation was discussed ( http://www.cms.gov/Regulations-and-Gu idance/Guidance/FACA/MEITAP.html 

### ). We continue to believe that the ECI for Wage s and Salaries for Hospital Workers (Private Industry) is the most technically appropriate proxy for the comp ensation price inflation faced by non-physician, health related staff in physician offi ces as this ECI reflects the highest proportion of health-related staff (as measured by the O ccupational Employment Statistics data) compared

to other ECIs. Should the commen ter have alternative price proxy suggestions, we will consider them in future rulemaking.

Comment : Several commenters agree with the proposed change in the price proxy for Fixed Capital, since it represents the types of fixed capital expenses most likely faced by physicians. Response : We agree with the commenters that the price proxy proposed for Fixed Capital is more representative of the types of fixed capital expenses faced by physicians.

6. Final CY 2014 Revisions to the MEI

### CMS-1600-FC 170

In general, most commenters supported all of the proposed changes to the index. The one

area where there was concern from commenters was with the proposal to reclassify expenses for non-physician practitioners that can independe ntly bill from non-physician compensation to physician compensation. Based on the public comments, we did not find any reason to reconsider our proposal, nor did we find any compelling technical reason that we should not implement this revision to the MEI. Therefore, we are finalizing our propos al to reclassify these expenses from non-physician compensation to physic ian compensation in the MEI. The effect of moving the expenses related to clinical sta ff that can bill independently to physician compensation category is to increase the physic ian compensation cost share by 2.600 percentage points and reduce non-physician co mpensation costs by the same am ount. The revisions we are finalizing include:

● Reclassifying expenses for non-physician cl inical personnel that can bill independently from non-physician compensation to physician compensation.

● Revising the physician wage and benefit split so that the cost weights are more in line with the definitions of the price pr oxies used for each category.

● Adding an additional subcategory unde r non-physician compen sation for healthrelated workers.

● Creating a new cost categor y called “All Other Profession al Services” that includes expenses covered in the current MEI categories: “All Other Services” an d “Other Professional Expenses.” And further disaggregating the “A ll Other Professional Se rvices” category into appropriate occupati onal subcategories.

### CMS-1600-FC 171

● Creating an aggregate cost category cal led “Miscellaneous Office Expenses” that would include the expenses for “Rubber and Plas tics,” “Chemicals,” “All Other Products,” and “Paper.”

● Revising the price proxy for physician wage s and salaries from the Average Hourly Earnings (AHE) for the Total Private Nonf arm Economy for Production and Nonsupervisory Workers to the ECI for Wages and Salaries, Professional and Related Occupations, Private Industry.

● Revising the price proxy for physician benefi ts from the ECI for Benefits for the Total Private Industry to the ECI for Benefits, Profes sional and Related Occupations, Private Industry.

● Using the ECI for Wages and Salaries and the ECI for Benefits of Hospital, Civilian workers (private industry) as the price proxies for the new ca tegory of non-phys ician healthrelated workers.

● Using ECIs to proxy the Professional Serv ices occupational subcat egories that reflect the type of professional services purchased by physicians’ offices.

● Revising the price proxy for the fixed capital category from the CPI for Owners’ Equivalent Rent of Residences to the PPI for Lessors of N onresidential Buildings (NAICS 53112).

Table 21 shows the final revised 2006-based MEI update for CY 2014 PFS, which is an increase of 0.8 percent. The CY 2014 MEI update would be the same if using the current 2006- based MEI. This update is based on histor ical data through the second quarter of 2013. TABLE 21: Annual Percent Change in the CY 2014 Revised 2006-Based MEI and the Current 2006-Based MEI * 

### Update Year Final Revised 2006- based MEI Current 2006-based MEI CY 2014 0.8 0.8 *Based on historical data through the 2nd quarter 2013.

### CMS-1600-FC 172

For the productivity adjustment , the 10-year moving average percent change adjustment for CY 2014 is 0.9 percent, which is based on the mo st historical data available from BLS at the time of the final rule, and reflect s annual MFP estimates through 2012. Table 22 shows the Cost Categories, Price Pr oxies, Cost Share Weights and the CY 2014 percent changes for each category in the revised 2 006-based MEI. This table summarizes all of

the final revisions to the MEI for CY2014.

TABLE 22: Annual Percent Change in the Revised MEI for CY 2014 (All Categories) 1



### Revised Cost Category Revised Price Proxy 2006 Final Revised Cost Weight 2 

### CY14 Update (percent) 5 

### MEI 100.000% 0.8

MFP 10-yr moving average of Private Nonfarm Business Multifactor Productivity N/A 0.9 MEI without productivity adjustment 100.000% 1.7 Physician Compensation 3 

### 50.866% 1.9 Wages and Salaries ECI - Wages and salaries - Professional and Related (private) 43.641% 1.9

Benefits ECI - Benefits - Professional and Related (private) 7.225% 2.2 Practice Expense 49.134% 1.4 Non-physician compensation 16.553% 1.7 Non-physician wages 11.885% 1.7Non-health, nonphysician wages 7.249% 1.8 Professional & Related ECI - Wages And Salaries - Professional and Related (Private) 0.800% 1.9

Management ECI - Wages And Salaries - Management, Business, and Financial (Private) 1.529% 1.8

Clerical ECI - Wages And Salaries - Office and Administrative Support 4.720% 1.8

### CMS-1600-FC 173

Revised Cost Category Revised Price Proxy 2006 Final Revised Cost Weight 2 

### CY14 Update (percent) 5 

### (Private)

Services ECI - Wages And Salaries - Service Occupations (Private) 0.200% 1.5 Health related, non-physician wages ECI - Wages and Salaries -Hospital (civilian) 4.636% 1.4 Non-physician benefits Composite Benefit Index 4.668% 1.9 Other Practice Expense 32.581% 1.2 Utilities CPI Fuels and Utilities 1.266% 0.7 Miscellaneous Office Expenses 2.478% 0.3

Chemicals Other Basic Organic Chemical Manufacturing PPI325190 0.723% -1.2 Paper PPI for converted paper 0.656% 1.1 Rubber & Plastics PPI for rubber and plastics 0.598% 0.5 All other products CPI - All Items Less Food And Energy 0.500% 1.9 Telephone CPI for Telephone 1.501% 0.0 Postage CPI for Postage 0.898% 4.9 All Other Professional Services 8.095% 1.8 Professional, Scientific, and Tech. Services ECI - Compensation: Prof. scientific, tech. 2.592% 1.7 Administrative and support & waste ECI - Compen sation Administrative 3.052% 1.9 All Other Services ECI Compensation: Services Occupations 2.451% 1.6 Capital 10.310% 0.7

Fixed PPI for Lessors of nonresidential buildings 8.957% 0.7 Moveable PPI for Machinery and Equipment 1.353% 0.7 Professional Liability Insurance 4 

### CMS - Prof. Liability. Phys. Prem. Survey 4.295% 1.5 Medical Equipment PPI - Med. Inst. & Equip. 1.978% 1.2 Medical supplies Composite - PPI Surg. Appl. & CPIU Med. Supplies. (CY2006) 1.760% 1.0 1 The estimates are based upon the latest available Bureau of Labor Statistics data on the 10-year moving average of BLS privat e nonfarm business multifactor productivity published on July 19, 2013 http://www.bls.gov/ne ws.release/prod3.nr0.htm 2 The weights shown for the MEI components are the 2006 base-year weights, which may not sum to subtotals or totals because of rounding. The MEI is a fixed-weight, Laspeyres input price index whose categor y weights indicate the distribution of

### CMS-1600-FC 174

expenditures among the inputs to physicians’ se rvices for CY 2006. To determine the MEI level for a given year, the price proxy level for each component is multiplied by its 2006 weight. The sum of these products (weights multiplied by the price index levels) yields the composite MEI level for a given year. The annual percent change in the MEI leve ls is an estimate of price change over time for a fixed market basket of inputs to physicians’ services. 3 The measures of Productivity, Average H ourly Earnings, Employment Cost Indexes, as well as the various Producer and Consumer Price Indexes can be found on the Bureau of La bor Statistics (BLS) Web site at http://s tats.bls.gov. 4 Derived from a CMS survey of se veral major commercial insurers. 5. Based on historical data through the 2 nd quarter 2013. N

⁄ A Productivity is factored into the MEI as a subtraction from the total index growth ra te; therefore, no explicit weight exists for productivity in the MEI.

### CMS-1600-FC 175

E. Establishing RVUs for CY 2014 Section 1848(c)(2)(B) of the Ac t requires that we review RVUs for physicians’ services no less often than every 5 years. Under secti on 1848(c)(2)(K) of the Ac t (as added by section 3134 of the Affordable Care Act), we are requir ed to identify and revise RVUs for services identified as potentially misvalued. To facilit ate the review and appropriate adjustment of potentially misvalued services, section 1848(c)(2 )(K)(iii) specifies that the Secretary may use existing processes to receive recommendations; c onduct surveys, other data collection activities, studies, or other analyses as the Secretary de termined to be appropr iate; and use analytic contractors to identify and analyze potentiall y misvalued services, conduct surveys or collect

data. In accordance with sect ion 1848(c)(2)(K)(iii ) of the Act, we identi fy potentially misvalued codes, and develop and propose appropriate adju stments to the RVUs, taking into account the recommendations provided by the AMA RUC, the Medicare Payment Advisory Commission (MedPAC), and other public commenters. For many years, the AMA RUC has provided CMS with recommendations on the appropriate relative values for PFS services. Over the past sever al years, CMS and the AMA RUC have identified and reviewed a number of potentially misvalued codes on an annual basis, based on various identification screens for codes at risk for being misvalued. This annual review of work RVUs and direct PE inputs for potentially misvalued codes was further bolstered by the Affordable Care Act mandate to examine potentially misvalued codes, with an emphasis on the following categories specified in section 1848(c)(2)(K)(ii) of the Act (as added by sec tion 3134 of the Affordable Care Act):

● Codes and families of codes for whic h there has been the fastest growth.

● Codes or families of codes that have experi enced substantial changes in practice expenses.

● Codes that are recently established for new technologies or services.

● Multiple codes that are frequently billed in conjunction with furnishing a single service.

### CMS-1600-FC 176

● Codes with low relative values, particularly those that are often billed multiple times for a single treatment.

● Codes which have not been subject to revi ew since the implementation of the RBRVS (the “Harvard-valued” codes).

● Other codes determined to be appropriate by the Secretary. In addition to providing recommendations to CMS for work RVUs, the AMA RUC’s Practice Expense Subcommittee reviews, and then the AMA RUC recommends, direct PE inputs (clinical labor, disposable supplies, and medical equipment) for individual services. To guide the establishment of malpractice RVUs for new and revised codes before each Five-Year Review of Malpractice, the AMA RUC also provides malpractice crosswalk recomme ndations, that is, “source” codes with a similar specialty mix of practitioners furnishing the source code and the new/revised code. CMS reviews the AMA RUC recommendations on a code-by-code basis. For AMA RUC recommendations regarding physician work RVUs, afte r conducting a clinical review of the codes, we determine whether we agree with the recommended wo rk RVUs for a service (that is, whether we agree the AMA RUC recommended valuation is accurate). If we disagree, we determine an alternative value that better reflects our estimate of the physician work for the service. Because of the timing of the CPT Editorial Panel decisions, the AMA RUC recommendations, and our rulemaking cycle, we publish these work R VUs in the PFS final rule with comment period as interim final values, subject to public comment. Similarly, we assess the AMA RUC’s recommendations for direct PE inputs and malpractice crosswalks, and establish interim final direct PE inputs and malpractice RVUs, which are also subject to comment. We note that the main aspect of our PE valuation that is open for public comment for a new, revised, or potentially misvalued code is the direct PE inputs

and not the other elements of the PE valuation me thodology, such as the indirect cost allocation methodology, that also contribute to establishing the PE RVUs for a code. The public comment period on the PFS final rule with comment period remains open for 60 days after the rule is issued.

### CMS-1600-FC 177

In the interval between closure of the comment period and the subsequent year’s PFS final rule with comment period, we consider all of the public comments on the interim final work, PE, and malpractice RVUs for the new, revised, and potentiall y misvalued codes and the results of the refinement panel, if applicable. Finally, we address the interi m final work and malpracti ce RVUs and interim final direct PE inputs by providing a summary of the publ ic comments and our responses to those comments, including a discussion of any changes to the interim fi nal work or malpractice RVUs or direct PE inputs, in the following year’s PFS final rule with comment period. We then typically finalize the direct PE inputs and the work, PE, and malpractice RVUs for the service in that year’s PFS final rule with comment period, unless we determine it would be more appropriate to continue their interim final status for another year and solicit further public comment. 1. Methodology

We conducted a review of each code identified in this section and reviewed the current work RVU, if one exists, the AMA RUC-recommended wo rk RVUs, intensity, and time to furnish the preservice, intraservice, and postservice activities, as well as other components of the service that contribute to the value. Our review generally includ es, but is not limited to, a review of information provided by the AMA RUC, Health Care Professionals Advisory Committee (HCPAC), and other public commenters, medical literature, and comparative da tabases, as well as a comparison with other codes within the Medicare PFS, consultation with other ph ysicians and health care professionals within CMS and the federal government. We also assessed the methodology and data used to develop the recommendations submitted to us by the AMA RUC a nd other public commenters and the rationale for

the recommendations. As we noted in the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), there are a variety of methodologies and approaches used to develop work RVUs, including survey data, building blocks, crosswalk to key reference or similar codes, and magnitude estimation. When referring to a survey, unless othe rwise noted, we mean th e surveys conducted by specialty societies as part of the formal AMA RUC process. The building block methodology is used to construct, or deconstruct, the work RVU for a CPT code based on component pieces of the code.

### CMS-1600-FC 178

Components used in the building block approach may include preservice, intraservice, or postservice time and post-procedure visits. When referring to a bun dled CPT code, the components could be the CPT codes that make up the bundled code. Magnitude estimation refers to a methodology for valuing physician work that determines the appropriate work RVU for a service by gauging the total amount of physician work for that service relative to the physic ian work for similar service across the physician fee schedule without explicitly valuing the components of that work. The PFS incorporates cross-specialty and cross-orga n system relativity. Valuing services requires

an assessment of relative value and takes into account th e clinical intensity and time required to furnish a service. In selecting which methodological approach will best determine the appropriate value for a service, we consider the current and recommended work and time values, as well as the intensity of the service, all relative to other services. Several years ago, to aid in the development of preservice time recommendations for new and revised CPT codes, the AMA RUC created standardized preservice time packages. The packages include preservice evaluation time, preservice positioning time, and preservice scrub, dress and wait time. Currently there are six preservice time packages for services typically furnished in the facility setting, reflecting the different combinations of straightforwar d or difficult procedure, straightforward or difficult patient, and without or with sedation/anesthesia. Currently there are two preservice time packages for services typically furnished in the nonfacility se tting, reflecting procedures without and with

sedation/anesthesia care. We have developed several standard buildi ng block methodologies to appropriately value services when they have common billing patterns. In cases where a service is typically furnished to a beneficiary on the same day as an evaluation and management (E/M) service, we believe that there is overlap between the two services in some of the act ivities furnished during the preservice evaluation and postservice time. We believe that at least one-third of the physician time in both the preservice evaluation and postservice period is duplicative of work furnished during the E/M visit. Accordingly, in cases where we believe that the AMA RUC has not adequately accounted for the overlapping activities in the

### CMS-1600-FC 179

recommended work RVU and/or times, we adjust the work RVU and/or times to account for the overlap. The work RVU for a service is the product of th e time involved in furnishing the service times the intensity of the work. Preservice evaluation tim e and postservice time both have a long-established intensity of work per unit of time (IWPUT) of 0.0224, which means that 1 minute of preservice evaluation or postservice time equates to 0.0224 of a work RVU. Therefore, in many cases when we remove 2 minutes of preservice time and 2 minutes of postservice time from a procedure to account for the overlap with the same day E/M service, we also remove a work RVU of 0.09 (4 minutes × 0.0224 IWPUT) if we do not believe the overlap in time has already been accounted for in the work RVU. We continue to believe this adjustme nt is appropriate. The AMA RUC has recognized this valuation policy and, in many cases, addresses the overlap in time a nd work when a service is typically provided on the same day as an E/M service. 2. Responding to CY 2013 Interim Fina l RVUs and CY 2014 Proposed RVUs In this section, we address the interim final va lues published in the CY 2013 PFS final rule with comment period, as subsequently corrected in the correction notice (78 FR 48996), and the proposed values published in the CY 2014 PFS proposed rule. We discuss the results of the CY 2013 refinement panel for CY 2013 interim final codes the panel reviewed, respond to public comments received on specific interim final and proposed RVUs and direct PE inputs, and address the other new, revised, or potentially misvalued codes with interim final or propo sed values. The direct PE inputs are listed in a file called “CY 2014 PFS Direct PE Inputs,” available on the CMS website under downloads for the CY 2014 PFS final rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html . The final CY 2014 work, PE, and malpractice RVUs are in Addendum B of a file called “CY 2014 PFS Addenda,” available on the CMS

website under downloads for the CY 2014 PFS final rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Ser vice-Payment/PhysicianFeeSched/PFS-FederalRegulation-Notices.html

. (a) Finalizing CY 2013 Interim Final Work RVUs for CY 2014

### CMS-1600-FC 180

(i) Refinement Panel (1) Refinement Panel Process As discussed in the 1993 PFS final rule with comment period (57 FR 55938), we adopted a refinement panel process to assist us in reviewing the public comments on CPT codes with interim final work RVUs for a year and in developing final work values for the subsequent year. We decided the panel would be comprised of a multispecialty group of physicians who would review and discuss the work involved in each procedure under review, and then each panel member would individually rate the work of the procedure. We believed establishing the pa nel with a multispecialty group would balance the interests of the specialty societies who comme nted on the work RVUs with the budgetary and redistributive effects that could occur if we accepte d extensive increases in work RVUs across a broad range of services. Depending on the number and range of codes that are subject to refinement in a given year, we establish refinement panels with representa tives from four groups of physicians: Clinicians representing the specialty identified with the procedures in question; physicians with practices in related specialties; primary care physicians; and contractor medical directors (CMDs). Typical panels have included 8 to 10 physicians across the four groups. Following the addition of section 1848(c)(2)(K) to th e Act by Section 3134 of the Affordable Care Act, which required the Secretary periodically to review potentially misvalued codes and make appropriate adjustments to the RVUs, we reassessed th e refinement panel process. As detailed in the CY 2011 PFS final rule with comment period (75 FR 73306) , we believed that the refinement panel process may provide an opportunity to review and discuss th e proposed and interim final work RVUs with a clinically diverse group of experts, who then pr ovide informed recommendations. Therefore, we indicated that we would continue the refinement process, but with administrative modification and

clarification. We also noted that we would c ontinue using the established composition that includes representatives from the four groups of physicians – clinicians representing the specialty identified with the procedures in question, physicians with practices in related specialties, primary care physicians, and

CMDs.

### CMS-1600-FC 181

At that time, we made a change in how we calcu lated refinement panel results. The basis of the refinement panel process is that, following discussion of the information but without an attempt to reach a consensus, each member of the panel submits an inde pendent rating to CMS. Historically, the refinement panel’s recommendation to change a work value or to re tain the interim final value had hinged solely on the outcome of a statistical test on the ratings (an F-test of panel ratings among the groups of participants). Over time, we found the statistical test used to evaluate the RVU ratings of individual panel members became less reliable as the physicians in each group tended to select a previously discussed value, rather than developing a unique value, thereb y reducing the observed variability needed to conduct a robust statistical test. In addition, reliance on values developed using the F-test also occasionally resulted in rank order anomalies among services (that is, a more complex procedure is assigned lower RVUs than a less complex procedure). As a result, we eliminated the use of the statistical F-test and

instead used the median work value of the individual panel members’ rati ngs. We said that this approach would simplify the refinement process administratively, while providing a result that reflects the summary opinion of the panel members based on a commonly used measure of central tendency that is not significantly affected by outlier values. At the same time, we clarified that we have th e final authority to set the work RVUs, including making adjustments to the work RVUs resulting from th e refinement process, and that we will make such adjustments if warranted by policy concerns (75 FR 73307).

As we continue to strive to make the refi nement panel process as effective and efficient as possible, we would like to remind readers that the re finement panels are not intended to review every code for which we did not accept the AMA RUC-re commended work RVUs. Rather, the refinement panels are designed for situations where there is new information available that might provide a reason for a change in work values and for which a multispecial ty panel of physicians might provide input that would assist us in making work RVU decisions. To facilitate the selection of services for the refinement panels, we would like to remind specialty societies seeking reconsideration of interim final work RVUs, including consideration by a refinement panel, to speci fically state in their public comments that they are

### CMS-1600-FC 182

requesting refinement panel review. Furthermore, we have asked commenters requesting refinement panel review to submit sufficient new information con cerning the clinical aspects of the work assigned for

a service to indicate that referral to the refi nement panel is warranted (57 FR 55917). We note that most of the information presented during the last several refinement panel discussions has been duplicative of the information provided to the AMA RUC during its development of

recommendations. As detailed in section II.E.1. of th is final rule with comment period, we consider

information and recommendations from the AMA RUC when assigning proposed and interim final RVUs to services. Thus, if the only information that a commenter has to present is information already considered by the AMA RUC, referral to a refinement panel is not appr opriate. To facilitate selection of codes for refinement, we request that commenters seek ing refinement panel review of work RVUs submit supporting information that has not already been considered the AMA RUC in creating recommended work RVUs or by CMS in assigning proposed and inte rim final work RVUs. We can make best use of our resources as well as those of the specialties involve d and physician volunteers by avoiding duplicative consideration of information by the AMA RUC, CMS, and a refinement panel. To achieve this goal, CMS will continue to critically evaluate the need to refer codes to refinement panels in future years, specifically considering any new information provided by commenters. (2) CY 2013 Interim Final Work RVUs Considered by the Refinement Panel We referred to the CY 2013 refinement pane l 12 CPT codes with CY 2013 interim final work values for which we received a request for refineme nt that met the requirements described above. For these 12 CPT codes, all commenters requested increased work RVUs. For ease of discussion, we will be referring to these services as ‘‘refinement codes.” Consistent with the process described above, we convened a multi-specialty panel of ph ysicians to assist us in the revi ew of the information submitted to support increased work RVUs. The panel was moderate d by our physician advisors, and consisted of the following voting members:

● One to two clinicians represen ting the commenting organization.

### CMS-1600-FC 183

● One to two primary care clinicians nominated by the American Academy of Family Physicians and the American College of Physicians.

● Four Contractor Medical Directors (CMDs).

● One to two clinicians with practices in re lated specialties, who were expected to have knowledge of the services under review. The panel process was designed to capture each par ticipant’s independent ju dgment and his or her clinical experience which informed and drove the disc ussion of the refinement code during the refinement panel proceedings. Following the discussion, each vot ing participant rated the physician work of the refinement code and submitted those ratings to CMS directly and confidentially. We note that not all voting participants voted for every CPT code. There was no attempt to achieve consensus among the panel

members. As finalized in the CY 2011 PFS final rule with comment period (75 FR 73307), we calculated the median value for each service based upon the indivi dual ratings that were submitted to CMS by panel participants. Table 23 presents information on the work RVUs for the codes considered by the refinement panel, including the refinement panel ratings and the fi nal CY 2014 work RVUs. In section II.E.2.a.ii., we discuss each of the individual codes reviewed by the refinement panel. Table 23: Codes Reviewed by the 2013 Multi-Specialty Refinement Panel

HCPCS

Code Short Descriptor CY 2013 Interim Final Work RVU AMA RUC/HCPAC Recommended

Work RVU Refinement Panel Median Rating CY 2014 Work RVU 35475 Angioplasty, arterial 5.75 6.60 6.60 6.60 35476 Angioplasty, venous 4.71 5.10 5.10 5.10 93655 Arrhythmia ablation addon 7.50 9.00 9.00 7.50 93657 Afibablation add-on 7.50 10.00 10.00 7.50 95886 EMG extremity add-on 0.70 0.92 0.92 0.86

95887 EMG non-extremity addon 0.47 0.73 0.73 0.71

95908 Nerve conduction studies; 3-4 studies 1.25 1.37 1.37 1.25

### CMS-1600-FC 184

95909 Nerve conduction studies; 5-6 studies 1.50 1.77 1.77 1.50

95910 Nerve conduction studies; 7-8 studies 2.00 2.80 2.80 2.00

95911 Nerve conduction studies; 9-10 studies 2.50 3.34 3.34 2.50

92912 Nerve conduction studies; 11-12 studies 3.00 4.00 4.00 3.00

95913 Nerve conduction studies; 13 or more studies 3.56 4.20 4.20 3.56



### (ii)Code-Specific Issues Table 24 of this final rule with comment period lists all codes that had a CY 2013 interim final work value. This chart provides the CY 2013 work RVUs, the CY 2014 work RVUs and indicates whether we are finalizing the CY 2014 work RVUs. If there is no work RVUs listed, a letter indicates the relevant PFS procedure status indicator. A list of the PFS procedure status indicators can be found in

Addendum A. If the CY 2014 Action column indicates that the CY 2014 values are interim final, public comments on these values will be accepted during the pub lic comment period on this final rule with comment period. The comprehensive list of all CY 20 14 RVUs is in Addendum B to this final rule with comment period, which is contained in the “C Y 2014 PFS Addenda” available on the CMS website under

downloads for the CY 2014 PFS fina l rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Ser vice-Payment/PhysicianFeeSched/PFS-FederalRegulation-Notices.html . The comprehensive list of all CY 2013 values is in Addendum B to the CY

2013 Correction Notice which is contained in th e “CMS-1590-CN Addenda,” available on the CMS

website under downloads for the CY 2013 correction notice at http://www.cms.gov/Medicare/MedicareFee-for-Service-Payment/PhysicianFeeSch ed/PFS-Federal-Regulation-Notices.html . The time values for

all codes are listed in a file called “CY 2014 PFS Ph ysician Time,” available on the CMS website under

downloads for the CY 2014 PFS fina l rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Ser vice-Payment/PhysicianFeeSched/PFS-FederalRegulation-Notices.html

.

### CMS-1600-FC 185

TABLE 24: Codes with CY 2013 Interim Final Work Values

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

10120 Incision and removal of foreign body, subcutaneous tissues; simple 1.22 1.22 Finalize

11055 Paring or cutting of benign hyperkeratotic lesion (eg, corn or callus); single lesion 0.35 0.35 Finalize

11056 Paring or cutting of benign hyperkeratotic lesion (eg, corn or callus); 2 to 4 lesions 0.50 0.50 Finalize

11057 Paring or cutting of benign hyperkeratotic lesion (eg, corn or callus); more than 4 lesions 0.65 0.65 Finalize

11300 Shaving of epidermal or dermal lesion, single lesion, trunk, arms or legs; lesion diameter 0.5 cm or less 0.60 0.60 Finalize

11301 Shaving of epidermal or dermal lesion, single lesion, trunk, arms or legs; lesion diameter 0.6 to 1.0 cm 0.90 0.90 Finalize

11302 Shaving of epidermal or dermal lesion, single lesion, trunk, arms or legs; lesion diameter 1.1 to 2.0 cm 1.05 1.05 Finalize

11303 Shaving of epidermal or dermal lesion, single lesion, trunk, arms or legs; lesion diameter over 2.0 cm 1.25 1.25 Finalize

11305 Shaving of epidermal or dermal lesion, single lesion, scalp, neck, hands, feet, genitalia; lesion diameter 0.5 cm or less 0.80 0.80 Finalize

11306 Shaving of epidermal or dermal lesion, single lesion, scalp, neck, hands, feet, genitalia; lesion diameter 0.6 to 1.0 cm 0.96 0.96 Finalize

11307 Shaving of epidermal or dermal lesion, single lesion, scalp, neck, hands, feet, genitalia; lesion diameter 1.1 to 2.0 cm 1.20 1.20 Finalize

11308 Shaving of epidermal or dermal lesion, single lesion, scalp, neck, hands, feet, genitalia; lesion diameter over 2.0 cm 1.46 1.46 Finalize

11310 Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter 0.5 cm or less 0.80 0.80 Finalize

11311 Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter 0.6 to 1.0 cm 1.10 1.10 Finalize

11312 Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter 1.1 to 2.0 cm 1.30 1.30 Finalize

### CMS-1600-FC 186

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

11313 Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter over 2.0 cm 1.68 1.68 Finalize

11719 Trimming of nondystrophic nails, any number 0.17 0.17 Finalize

12035 Repair, intermediate, wounds of scalp, axillae, trunk and/ or extremities (excluding hands and feet); 12.6 cm to 20.0 cm 3.50 3.50 Finalize

12036 Repair, intermediate, wounds of scalp, axillae, trunk and/ or extremities (excluding hands and feet); 20.1 cm to 30.0 cm 4.23 4.23 Finalize

12037 Repair, intermediate, wounds of scalp, axillae, trunk and/ or extremities (excluding hands and feet); over 30.0 cm 5.00 5.00 Finalize

12045 Repair, intermediate, wounds of neck, hands, feet and/or external genitalia; 12.6 cm to 20.0 cm 3.75 3.75 Finalize

12046 Repair, intermediate, wounds of neck, hands, feet and/or external genitalia; 20.1 cm to 30.0 cm 4.30 4.30 Finalize

12047 Repair, intermediate, wounds of neck, hands, feet and/or external genitalia; over 30.0 cm 4.95 4.95 Finalize

12055 Repair, intermediate, wounds of face, ears, eyelids, nose, lips and/or mucous membranes; 12.6 cm to 20.0 cm 4.50 4.50 Finalize

12056 Repair, intermediate, wounds of face, ears, eyelids, nose, lips and/or mucous membranes; 20.1 cm to 30.0 cm 5.30 5.30 Finalize

12057 Repair, intermediate, wounds of face, ears, eyelids, nose, lips and/or mucous membranes; over 30.0 cm 6.00 6.00 Finalize 13100 Repair, complex, trunk; 1.1 cm to 2.5 cm 3.00 3.00 Finalize 13101 Repair, complex, trunk; 2.6 cm to 7.5 cm 3.50 3.50 Finalize

13102 Repair, complex, trunk; each additional 5 cm or less (list separately in addition to code for primary procedure) 1.24 1.24 Finalize 13120 Repair, complex, scalp, arms, and/or legs; 1.1 cm to 2.5 cm 3.23 3.23 Finalize 13121 Repair, complex, scalp, arms, and/or legs; 2.6 cm to 7.5 cm 4.00 4.00 Finalize

13122 Repair, complex, scalp, arms, and/or legs; each additional 5 cm or less (list separately in addition to code for primary procedure) 1.44 1.44 Finalize

13131 Repair, complex, forehead, cheeks, chin, mouth, neck, axillae, genitalia, hands and/or feet; 1.1 cm to 2.5 cm 3.73 3.73 Finalize

13132 Repair, complex, forehead, cheeks, chin, mouth, neck, axillae, genitalia, hands and/or feet; 2.6 cm to 7.5 cm 4.78 4.78 Finalize

### CMS-1600-FC 187

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

13133 Repair, complex, forehead, cheeks, chin, mouth, neck, axillae, genitalia, hands and/or feet; each additional 5 cm or less (list separately in addition to code for primary procedure) 2.19 2.19 Finalize

13150 Repair, complex, eyelids, nose, ears and/or lips; 1.0 cm or less 3.58 D D

13151 Repair, complex, eyelids, nose, ears and/or lips; 1.1 cm to 2.5 cm 4.34 4.34 Finalize

13152 Repair, complex, eyelids, nose, ears and/or lips; 2.6 cm to 7.5 cm 4.90 5.34 Finalize

13153 Repair, complex, eyelids, nose, ears and/or lips; each additional 5 cm or less (list separately in addition to code for primary procedure) 2.38 2.38 Finalize

20985 Computer-assisted surgical navigational procedure for musculoskeletal procedures, image-less (list separately in addition to code for primary procedure) 2.50 2.50 Finalize

22586 Arthrodesis, pre-sacral interbody technique, including disc space preparation, discectomy, with posterior instrumentation, with image guidance, includes bone graft when performed, l5-s1 interspace 28.12 28.12 Finalize

23350 Injection procedure for shoulder arthrography or enhanced ct/mri shoulder arthrography 1.00 1.00 Finalize

23331 Removal of foreign body, shoulder; deep (eg, neer hemiarthroplasty removal) 7.63 D D

23332 Removal of foreign body, shoulder; complicated (eg, total shoulder) 12.37 D D

23472 Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (eg, total shoulder)) 22.13 22.13 Finalize

23473 Revision of total shoulder arthroplasty, including allograft when performed; humeral or glenoid component 25.00 25.00 Finalize

23474 Revision of total shoulder arthroplasty, including allograft when performed; humeral and glenoid component 27.21 27.21 Finalize

23600 Closed treatment of proximal humeral (surgical or anatomical neck) fracture; without manipulation 3.00 3.00 Interim Final 24160 Implant removal; elbow joint 8.00 18.63 Interim Final

### CMS-1600-FC 188

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

24363 Arthroplasty, elbow; with distal humerus and proximal ulnar prosthetic replacement (eg, total elbow) 22.00 22.00 Finalize

24370 Revision of total elbow arthroplasty, including allograft when performed; humeral or ulnar component 23.55 23.55 Finalize

24371 Revision of total elbow arthroplasty, including allograft when performed; humeral and ulnar component 27.50 27.50 Finalize

28470 Closed treatment of metatarsal fracture; without manipulation, each 2.03 2.03 Interim Final 29075 Application, cast; elbow to finger (short arm) 0.77 0.77 Interim Final

29581 Application of multi-layer compression system; leg (below knee), including ankle and foot 0.25 0.25 Interim Final

29582 Application of multi-layer compression system; thigh and leg, including ankle and foot, when performed 0.35 0.35 Interim Final

29583 Application of multi-layer compression system; upper arm and forearm 0.25 0.25 Interim Final

29584 Application of multi-layer compression system; upper arm, forearm, hand, and fingers 0.35 0.35 Interim Final

29824 Arthroscopy, shoulder, surgical; distal claviculectomy including distal articular surface (mumford procedure) 8.98 8.98 Interim Final

29826 Arthroscopy, shoulder, surgical; decompression of subacromial space with partial acromioplasty, with coracoacromial ligament (ie, ar ch) release, when performed (list separately in addition to code for primary procedure) 3.00 3.00 Interim Final

29827 Arthroscopy, shoulder, surgical; with rotator cuff repair 15.59 15.59 Finalize 29828 Arthroscopy, shoulder, surgical; biceps tenodesis 13.16 13.16 Finalize

31231 Nasal endoscopy, diagnostic, unilateral or bilateral (separate procedure) 1.10 1.10 Finalize

31647 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with balloon occlusion, when performed, assessment of air leak, airway sizing, and insertion of bronchial valve(s), initial lobe 4.40 4.40 Finalize

31648 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with removal of bronchial valve(s), initial lobe 4.20 4.20 Finalize

### CMS-1600-FC 189

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

31649 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with removal of bronchial valve(s), each additional lobe (list separately in addition to code for primary procedure) 1.44 1.44 Finalize

31651 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with balloon occlusion, when performed, assessment of air leak, airway sizing, and insertion of bronchial valve(s), each additional lobe (list separately in addition to code for primary procedure[s]) 1.58 1.58 Finalize

31660 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial thermoplasty, 1 lobe 4.25 4.25 Finalize

31661 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial thermoplasty, 2 or more lobes 4.50 4.50 Finalize

32440 Removal of lung, pneumonectomy; 27.28 27.28 Finalize

32480 Removal of lung, other than pneumonectomy; single lobe (lobectomy) 25.82 25.82 Finalize

32482 Removal of lung, other than pneumonectomy; 2 lobes (bilobectomy) 27.44 27.44 Finalize

32491 Removal of lung, other than pneumonectomy; with resection-plication of emphysematous lung(s) (bullous or non-bullous) for lung volume reduction, sternal split or transthoracic approach, includes any pleural procedure, when performed 25.24 25.24 Finalize

32551 Tube thoracostomy, includes connection to drainage system (eg, water seal), when perform ed, open (separate procedure) 3.29 3.29 Finalize

32554 Thoracentesis, needle or catheter, aspiration of the pleural space; without imaging guidance 1.82 1.82 Finalize

32555 Thoracentesis, needle or catheter, aspiration of the pleural space; with imaging guidance 2.27 2.27 Finalize

32556 Pleural drainage, percutaneous, with insertion of indwelling catheter; without imaging guidance 2.50 2.50 Finalize

32557 Pleural drainage, percutaneous, with insertion of indwelling catheter; with imaging guidance 3.12 3.12 Finalize 32663 Thoracoscopy, surgical; with lobectomy (single lobe) 24.64 24.64 Finalize

### CMS-1600-FC 190

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

32668 Thoracoscopy, surgical; with diagnostic wedge resection followed by anatomic lung resection (list separately in addition to code for primary procedure) 3.00 3.00 Finalize

32669 Thoracoscopy, surgical; with removal of a single lung segment (segmentectomy) 23.53 23.53 Finalize

32670 Thoracoscopy, surgical; with removal of two lobes (bilobectomy) 28.52 28.52 Finalize

32671 Thoracoscopy, surgical; with removal of lung (pneumonectomy) 31.92 31.92 Finalize

32672 Thoracoscopy, surgical; with resection-plication for emphysematous lung (bullous or non-bullous) for lung volume reduction (lvrs), unilateral includes any pleural procedure, when performed 27.00 27.00 Finalize

32673 Thoracoscopy, surgical; with r esection of thymus, unilateral or bilateral 21.13 21.13 Finalize

32701 Thoracic target(s) delineation fo r stereotactic body radiation therapy (srs/sbrt), (photon or particle beam), entire course of treatment 4.18 4.18 Finalize

33361 Transcatheter aortic valve replacement (tavr/tavi) with prosthetic valve; percutane ous femoral artery approach 25.13 25.13 Finalize

33362 Transcatheter aortic valve replacement (tavr/tavi) with prosthetic valve; open femoral artery approach 27.52 27.52 Finalize

33363 Transcatheter aortic valve replacement (tavr/tavi) with prosthetic valve; open axillary artery approach 28.50 28.50 Finalize

33364 Transcatheter aortic valve replacement (tavr/tavi) with prosthetic valve; open iliac artery approach 30.00 30.00 Finalize

33365 Transcatheter aortic valve replacement (tavr/tavi) with prosthetic valve; transaortic approach (eg, median sternotomy, mediastinotomy) 33.12 33.12 Finalize

33367 Transcatheter aortic valve replacement (tavr/tavi) with prosthetic valve; cardiopulmonary bypass support with percutaneous peripheral arteri al and venous cannulation (eg, femoral vessels) (list separately in addition to code for primary procedure) 11.88 11.88 Finalize

### CMS-1600-FC 191

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

33368 Transcatheter aortic valve replacement (tavr/tavi) with prosthetic valve; cardiopulm onary bypass support with open peripheral arterial and venous ca nnulation (eg, femoral, iliac, axillary vessels) (list separatel y in addition to code for primary procedure) 14.39 14.39 Finalize

33369 Transcatheter aortic valve replacement (tavr/tavi) with prosthetic valve; cardiopulmonary bypass support with central arterial and venous cannulation (eg, aorta, right atrium, pulmonary artery) (list separately in addition to code for primary procedure) 19.00 19.00 Finalize

33405 Replacement, aortic valve, with cardiopulmonary bypass; with prosthetic valve other than homograft or stentless valve 41.32 41.32 Finalize 33430 Replacement, mitral valve, with cardiopulmonary bypass 50.93 50.93 Finalize

33533 Coronary artery bypass, using arterial graft(s); single arterial graft 33.75 33.75 Finalize

33990 Insertion of ventricular assist device, percutaneous including radiological supervision and interpretation; arterial access only 8.15 8.15 Finalize

33991 Insertion of ventricular assist device, percutaneous including radiological supervision and interpretation; both arterial and venous access, with transseptal puncture 11.88 11.88 Finalize

33992 Removal of percutaneous ventricular assist device at separate and distinct session from insertion 4.00 4.00 Finalize

33993 Repositioning of percutaneous ventricular assist device with imaging guidance at separate and distinct session from insertion 3.51 3.51 Finalize

35475 Transluminal balloon angioplasty, percutaneous; brachiocephalic trunk or branches, each vessel 5.75 6.60 Finalize 35476 Transluminal balloon angioplasty, percutaneous; venous 4.71 5.10 Finalize

36221 Non-selective catheter placement, thoracic aorta, with angiography of the extracranial carotid, vertebral, and/or intracranial vessels, unilateral or bilateral, and all associated radiological supervision and interpretation, includes angiography of the cervicocer ebral arch, when performed 4.17 4.17 Finalize

### CMS-1600-FC 192

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

36222 Selective catheter placement, common carotid or innominate artery, unilateral, any approach, with angiography of the ipsilateral extracranial carotid circulation and all associated radiological supervision and interpretation, includes angiography of the cervicocer ebral arch, when performed 5.53 5.53 Finalize

36223 Selective catheter placement, common carotid or innominate artery, unilateral, any approach, with angiography of the ipsilateral intracranial carotid circulation and all associated radiological supervision and interpretation, includes angiography of the extracranial carotid and cervicocerebral arch, when performed 6.00 6.00 Finalize

36224 Selective catheter placement, internal carotid artery, unilateral, with angiography of the ipsilateral intracranial carotid circulation and all associated radiological supervision and interpretation, includes a ngiography of the extracranial carotid and cervicocerebral arch, when performed 6.50 6.50 Finalize

36225 Selective catheter placement, subclavian or innominate artery, unilateral, with angiography of the ipsilateral vertebral circulation and all associated radiological supervision and interpretation, includes angiography of the cervicocerebral arch, when performed 6.00 6.00 Finalize

36226 Selective catheter placement, vertebral artery, unilateral, with angiography of the ipsilateral vertebral circulation and all associated radiological supervision and interpretation, includes angiography of the cervicocerebral arch, when performed 6.50 6.50 Finalize

36227 Selective catheter placement, external carotid artery, unilateral, with angiography of the ipsilateral external carotid circulation and all associated radiological supervision and interpretation (list separat ely in addition to code for primary procedure) 2.09 2.09 Finalize

36228 Selective catheter placement, each intracranial branch of the internal carotid or vertebral arteries, unilateral, with angiography of the selected vessel circulation and all associated radiological supervision and interpretation (eg, middle cerebral artery, posterior inferior cerebellar artery) (list separately in addition to code for primary procedure) 4.25 4.25 Finalize

### CMS-1600-FC 193

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

37197 Transcatheter retrieval, percutaneous, of intravascular foreign body (eg, fractured venous or arterial catheter), includes radiological supervision and interpretation, and imaging guidance (ultrasound or fluoroscopy), when performed 6.29 6.29 Finalize

37211 Transcatheter therapy, arterial infusion for thrombolysis other than coronary, any method, including radiological supervision and interpreta tion, initial treatment day 8.00 8.00 Finalize

37212 Transcatheter therapy, venous in fusion for thrombolysis, any method, including radiological supervision and interpretation, initial treatment day 7.06 7.06 Finalize

37213 Transcatheter therapy, arterial or venous infusion for thrombolysis other than coronary, any method, including radiological supervision and interpretation, continued treatment on subsequent day during course of thrombolytic therapy, including follow-up catheter contrast injection, position change, or exchange, when performed; 5.00 5.00 Finalize

37214 Transcatheter therapy, arterial or venous infusion for thrombolysis other than coronary, any method, including radiological supervision and interpretation, continued treatment on subsequent day during course of thrombolytic therapy, including follow-up catheter contrast injection, position change, or exchange, when performed; 2.74 2.74 Finalize

38240 Hematopoietic progenitor cell (hpc); allogeneic transplantation per donor 3.00 4.00 Finalize

38241 Hematopoietic progenitor cell (hpc); autologous transplantation 3.00 3.00 Finalize 38242 Allogeneic lymphocyte infusions 2.11 2.11 Finalize 38243 Hematopoietic progenitor cell (hpc); hpc boost 2.13 2.13 Finalize 40490 Biopsy of lip 1.22 1.22 Finalize

43206 Esophagoscopy, rigid or flexible; with optical endomicroscopy C 2.39 Interim Final

43252 Upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate; with optical endomicroscopy C 3.06 Interim Final

44705 Preparation of fecal microbiota for instillation, including assessment of donor specimen I I Finalize

### CMS-1600-FC 194

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

45330 Sigmoidoscopy, flexible; diagnostic, with or without collection of specimen(s) by brushing or washing (separate procedure) 0.96 0.96 Finalize 47562 Laparoscopy, surgical; cholecystectomy 10.47 10.47 Finalize

47563 Laparoscopy, surgical; cholecystectomy with cholangiography 11.47 11.47 Finalize 47600 Cholecystectomy; 17.48 17.48 Finalize 47605 Cholecystectomy; with cholangiography 18.48 18.48 Finalize 49505 Repair initial inguinal hernia, age 5 y ears or older; reducible 7.96 7.96 Finalize 50590 Lithotripsy, extracorporeal shock wave 9.77 9.77 Finalize

52214 Cystourethroscopy, with fulguration (including cryosurgery or laser surgery) of trigone, bladder neck, prostatic fossa, urethra, or periurethral glands 3.50 3.50 Finalize

52224 Cystourethroscopy, with fulguration (including cryosurgery or laser surgery) or treatment of minor (less than 0.5 cm) lesion(s) with or without biopsy 4.05 4.05 Finalize

52234 Cystourethroscopy, with fulguration (including cryosurgery or laser surgery) and/or resection of; small bladder tumor(s) (0.5 up to 2.0 cm) 4.62 4.62 Finalize

52235 Cystourethroscopy, with fulguration (including cryosurgery or laser surgery) and/or resection of; medium bladder tumor(s) (2.0 to 5.0 cm) 5.44 5.44 Finalize

52240 Cystourethroscopy, with fulguration (including cryosurgery or laser surgery) and/or resection of; large bladder tumor(s) 7.50 7.50 Finalize

52287 Cystourethroscopy, with injection(s) for chemodenervation of the bladder 3.20 3.20 Finalize

52351 Cystourethroscopy, with ureteroscopy and/or pyeloscopy; diagnostic 5.75 5.75 Finalize

52352 Cystourethroscopy, with ureteroscopy and/or pyeloscopy; with removal or manipulation of calculus (ureteral catheterization is included) 6.75 6.75 Finalize

52353 Cystourethroscopy, with ureteroscopy and/or pyeloscopy; with lithotripsy (ureteral catheterization is included) 7.50 7.50 Finalize

52354 Cystourethroscopy, with ureteroscopy and/or pyeloscopy; with biopsy and/or fulguration of ureteral or renal pelvic lesion 8.00 8.00 Finalize

### CMS-1600-FC 195

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

52355 Cystourethroscopy, with ureteroscopy and/or pyeloscopy; with resection of ureteral or renal pelvic tumor 9.00 9.00 Finalize

53850 Transurethral destruction of prostate tissue; by microwave thermotherapy 10.08 10.08 Finalize

60520 Thymectomy, partial or total; transcervical approach (separate procedure) 17.16 17.16 Finalize

60521 Thymectomy, partial or total; sternal split or transthoracic approach, without radical mediastinal dissection (separate procedure) 19.18 19.18 Finalize

60522 Thymectomy, partial or total; sternal split or transthoracic approach, with radical mediastinal dissection (separate procedure) 23.48 23.48 Finalize

64450 Injection, anesthetic agent; other peri pheral nerve or branch 0.75 0.75 Finalize

64612 Chemodenervation of muscle(s); muscle(s) innervated by facial nerve, unilateral (eg, for blepharospasm, hemifacial spasm) 1.41 1.41 Finalize

64613 Chemodenervation of muscle(s); neck muscle(s) (eg, for spasmodic torticollis, spasmodic dysphonia) 2.01 D D

64614 Chemodenervation of muscle(s); extremity and/or trunk muscle(s) (eg, for dystonia , cerebral palsy, multiple sclerosis) 2.20 D D

64615 Chemodenervation of muscle(s); muscle(s) innervated by facial, trigeminal, cervical spinal and accessory nerves, bilateral (eg, for chronic migraine) 1.85 1.85 Finalize

64640 Destruction by neurolytic agent; other peripheral nerve or branch 1.23 1.23 Finalize

65222 Removal of foreign body, exte rnal eye; corneal, with slit lamp 0.84 0.84 Finalize

65800 Paracentesis of anterior chamber of eye (separate procedure); with removal of aqueous 1.53 1.53 Finalize

### CMS-1600-FC 196

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

66982 Extracapsular cataract removal with insertion of intraocular lens prosthesis (1-stage procedure), manual or mechanical technique (eg, irrigation and aspiration or phacoemulsification), complex, requiring devices or techniques not generally used in routine cataract surgery (eg, iris expansion device, suture support for intraocular lens, or primary posterior capsulorrhexis) or performed on patients in the amblyogenic developmental stage 11.08 11.08 Finalize

66984 Extracapsular cataract removal with insertion of intraocular lens prosthesis (1 stage procedure), manual or mechanical technique (eg, irrigation and aspiration or phacoemulsification) 8.52 8.52 Finalize

67028 Intravitreal injection of a pharmacologic agent (separate procedure) 1.44 1.44 Finalize 67810 Incisional biopsy of eyelid skin including lid margin 1.18 1.18 Finalize 68200 Subconjunctival injection 0.49 0.49 Finalize

69200 Removal foreign body from external auditory canal; without general anesthesia 0.77 0.77 Finalize

69433 Tympanostomy (requiring insertion of ventilating tube), local or topical anesthesia 1.57 1.57 Finalize 72040 Radiologic examination, spine, cervical; 3 views or less 0.22 0.22 Finalize 72050 Radiologic examination, spine, cervical; 4 or 5 views 0.31 0.31 Finalize 72052 Radiologic examination, spine, cervical; 6 or more views 0.36 0.36 Finalize

72191 Computed tomographic angiography, pelvis, with contrast material(s), including noncontrast images, if performed, and image postprocessing 1.81 1.81 Interim Final

73221 Magnetic resonance (eg, proton) imaging, any joint of upper extremity; without contrast material(s) 1.35 1.35 Finalize

73721 Magnetic resonance (eg, proton) imaging, any joint of lower extremity; without contrast material 1.35 1.35 Finalize

74170 Computed tomography, abdomen; without contrast material, followed by contrast material(s) and further sections 1.40 1.40 Finalize

74174 Computed tomographic angiography, abdomen and pelvis, with contrast material(s), including noncontrast images, if performed, and image postprocessing 2.20 2.20 Finalize

### CMS-1600-FC 197

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

74175 Computed tomographic angiography, abdomen, with contrast material(s), including noncontrast images, if performed, and image postprocessing 1.90 1.90 Finalize

74247 Radiological examination, gastrointestinal tract, upper, air contrast, with specific high density barium, effervescent agent, with or without glucagon; with or without delayed films, with kub 0.69 0.69 Finalize

74280 Radiologic examination, colon; air contrast with specific high density barium, with or without glucagon 0.99 0.99 Finalize

74400 Urography (pyelography), intravenous, with or without kub, with or without tomography 0.49 0.49 Finalize

75896-26 Transcatheter therapy, infusion, other than for thrombolysis, radiological supervision and interpretation 1.31 1.31 Interim Final

75896-TC Transcatheter therapy, infusion, other than for thrombolysis, radiological supervision and interpretation C C Interim Final

75898-26 Angiography through existing catheter for follow-up study for transcatheter therapy, embolization or infusion, other than for thrombolysis 1.65 1.65 Interim Final

75898-TC Angiography through existing catheter for follow-up study for transcatheter therapy, embolization or infusion, other than for thrombolysis C C Interim Final 76830 Ultrasound, transvaginal 0.69 0.69 Finalize 76872 Ultrasound, transrectal; 0.69 0.69 Finalize

77001 Fluoroscopic guidance for central venous access device placement, replacement (catheter only or complete), or removal (includes fluoroscopic guidance for vascular access and catheter manipulation, any necessary contrast injections through access site or catheter with related venography radiologic supervision and interpretation, and radiographic documentation of final catheter position) (list separately in addition to code for primary procedure) 0.38 0.38 Interim Final

77002 Fluoroscopic guidance for needle placement (eg, biopsy, aspiration, injection, localization device) 0.54 0.54 Interim Final

77003 Fluoroscopic guidance and localization of needle or catheter tip for spine or paraspinous diagnostic or therapeutic injection procedures (epidural or subarachnoid) 0.60 0.60 Interim Final

### CMS-1600-FC 198

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

77080 Dual-energy x-ray absorptiometry (dxa), bone density study, 1 or more sites; axial skeleton (eg, hips, pelvis, spine) 0.20 0.20 Finalize

77082 Dual-energy x-ray absorptiometry (dxa), bone density study, 1 or more sites; vertebral fracture assessment 0.17 0.17 Finalize

77301 Intensity modulated radiotherapy plan, including dosevolume histograms for target and critical structure partial tolerance specifications 7.99 7.99 Finalize

78012 Thyroid uptake, single or multiple quantitative measurement(s) (including stimulation, suppression, or discharge, when performed) 0.19 0.19 Finalize

78013 Thyroid imaging (including vascular flow, when performed); 0.37 0.37 Finalize

78014 Thyroid imaging (including vascular flow, when performed); with single or multiple uptake(s) quantitative measurement(s) (including stimulation, suppression, or discharge, when performed) 0.50 0.50 Finalize

78070 Parathyroid planar imaging (including subtraction, when performed); 0.80 0.80 Finalize

78071 Parathyroid planar imaging (including subtraction, when performed); with tomographic (spect) 1.20 1.20 Finalize

78072 Parathyroid planar imaging (including subtraction, when performed); with tomographic (spect), and concurrently acquired computed tomography (ct) for anatomical localization 1.60 1.60 Finalize

78278 Acute gastrointestinal blood loss imaging 0.99 0.99 Finalize

78472 Cardiac blood pool imaging, gated equilibrium; planar, single study at rest or stress (exercise and/or pharmacologic), wall motion study plus ejection fraction, with or without additional quantitative processing 0.98 0.98 Finalize

86153 Cell enumeration using immunologic selection and identification in fluid specimen (eg, circulating tumor cells in blood); physician interpreta tion and report, when required 0.69 0.69 Finalize

88120 Cytopathology, in situ hybridization (eg, fish), urinary tract specimen with morphometric anal ysis, 3-5 molecular probes, each specimen; manual 1.20 1.20 Interim Final

88121 Cytopathology, in situ hybridization (eg, fish), urinary tract specimen with morphometric anal ysis, 3-5 molecular probes, each specimen; using computer-assisted technology 1.00 1.00 Interim Final

### CMS-1600-FC 199

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

88312 Special stain including interpretation and report; group i for microorganisms (eg, acid fast, methenamine silver) 0.54 0.54 Finalize

88365 In situ hybridization (e g, fish), each probe 1.20 1.20 Interim Final

88367 Morphometric analysis, in situ hybridization (quantitative or semi-quantitative) each probe; using computer-assisted technology 1.30 1.30 Interim Final

88368 Morphometric analysis, in situ hybridization (quantitative or semi-quantitative) each probe; manual 1.40 1.40 Interim Final

88375 Optical endomicroscopic image(s) , interpretation and report, real-time or referred, each endoscopic session C I Interim Final

90785 Interactive complexity (list separately in addition to the code for primary procedure) 0.11 0.33 Interim Final 90791 Psychiatric diagnostic evaluation 2.80 3.00 Interim Final 90792 Psychiatric diagnostic evaluati on with medical services 2.96 3.25 Interim Final 90832 Psychotherapy, 30 minutes w ith patient and/or family member 1.25 1.50 Interim Final

90833 Psychotherapy, 30 minutes w ith patient and/or family member when performed with an evaluation and management service (list separate ly in addition to the code for primary procedure) 0.98 1.50 Interim Final

90834 Psychotherapy, 45 minutes w ith patient and/or family member 1.89 2.00 Interim Final

90836 Psychotherapy, 45 minutes w ith patient and/or family member when performed with an evaluation and management service (list separate ly in addition to the code for primary procedure) 1.60 1.90 Interim Final

90837 Psychotherapy, 60 minutes w ith patient and/or family member 2.83 3.00 Interim Final

90838 Psychotherapy, 60 minutes w ith patient and/or family member when performed with an evaluation and management service (list separate ly in addition to the code for primary procedure) 2.56 2.50 Interim Final

90839 Psychotherapy for crisis; first 60 minutes C 3.13 Interim Final

### CMS-1600-FC 200

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

90840 Psychotherapy for crisis; each additional 30 minutes (list separately in addition to code for primary service) C 1.50 Interim Final 90845 Psychoanalysis 1.79 2.10 Interim Final 90846 Family psychotherapy (without the patient present) 1.83 2.40 Interim Final

90847 Family psychotherapy (conjoint psychotherapy) (with patient present) 2.21 2.50 Interim Final 90853 Group psychotherapy (other than of a multiple-family group) 0.59 0.59 Interim Final

90863 Pharmacologic management, including prescription and review of medication, when performed with psychotherapy services (list separately in addition to the code for primary procedure) I I Interim Final

91112 Gastrointestinal transit and pressure measurement, stomach through colon, wireless capsule, with interpretation and report 2.10 2.10 Finalize

92083 Visual field examination, unilateral or bilateral, with interpretation and report; ex tended examination (eg, goldmann visual fields with at least 3 isopters plotted and static determination within th e central 30¡, or quantitative, automated threshold perimetry, octopus program g-1, 32 or 42, humphrey visual field analyzer full threshold programs 30-2, 24-2, or 30/60-2) 0.50 0.50 Finalize

92100 Serial tonometry (separate procedure) with multiple measurements of intraocular pressure over an extended time period with interpretation and report, same day (eg, diurnal curve or medical treatment of acute elevation of intraocular pressure) 0.61 0.61 Finalize

92235 Fluorescein angiography (includes multiframe imaging) with interpretation and report 0.81 0.81 Finalize

92286 Anterior segment imaging with interpretation and report; with specular microscopy a nd endothelial cell analysis 0.40 0.40 Finalize

92920 Percutaneous transluminal coronary angioplasty; single major coronary artery or branch 10.10 10.10 Finalize

92921 Percutaneous transluminal coronary angioplasty; each additional branch of a major coronary artery (list separately in addition to code for primary procedure) B B Finalize

### CMS-1600-FC 201

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

92924 Percutaneous transluminal coronary atherectomy, with coronary angioplasty when performed; single major coronary artery or branch 11.99 11.99 Finalize

92925 Percutaneous transluminal coronary atherectomy, with coronary angioplasty when performed; each additional branch of a major coronary artery (list separately in addition to code for primary procedure) B B Finalize

92928 Percutaneous transcatheter placement of intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch 11.21 11.21 Finalize

92929 Percutaneous transcatheter placement of intracoronary stent(s), with coronary angioplasty when performed; each additional branch of a major coronary artery (list separately in addition to code for primary procedure) B B Finalize

92933 Percutaneous transluminal coronary atherectomy, with intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch 12.54 12.54 Finalize

92934 Percutaneous transluminal coronary atherectomy, with intracoronary stent, with coronary angioplasty when performed; each additional branch of a major coronary artery (list separately in addition to code for primary procedure) B B Finalize

92937 Percutaneous transluminal revascularization of or through coronary artery bypass graft (internal mammary, free arterial, venous), any combination of intracoronary stent, atherectomy and angioplasty, including distal protection when performed; single vessel 11.20 11.20 Finalize

92938 Percutaneous transluminal revascularization of or through coronary artery bypass graft (internal mammary, free arterial, venous), any combination of intracoronary stent, atherectomy and angioplasty, including distal protection when performed; each additional branch subtended by the bypass graft (list separately in addition to code for primary procedure) B B Finalize

### CMS-1600-FC 202

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

92941 Percutaneous transluminal revascularization of acute total/ subtotal occlusion during acute myocardial infarction, coronary artery or coronary artery bypass graft, any combination of intracoronary stent, atherectomy and angioplasty, including aspiration thrombectomy when performed, single vessel 12.56 12.56 Finalize

92943 Percutaneous transluminal revascularization of chronic total occlusion, coronary artery, coronary artery branch, or coronary artery bypass graft, any combination of intracoronary stent, atherectomy and angioplasty; single vessel 12.56 12.56 Finalize

92944 Percutaneous transluminal revascularization of chronic total occlusion, coronary artery, coronary artery branch, or coronary artery bypass graft, any combination of intracoronary stent, atherectomy and angioplasty; each additional coronary artery, cor onary artery branch, or bypass graft (list separately in addition to code for primary procedure) B B Finalize

93015 Cardiovascular stress test using maximal or submaximal treadmill or bicycle exercise, continuous electrocardiographic monitoring, and/or pharmacological stress; with supervision, interpretation and report 0.75 0.75 Finalize

93016 Cardiovascular stress test using maximal or submaximal treadmill or bicycle exercise, continuous electrocardiographic monitoring, and/or pharmacological stress; supervision only, without interpretation and report 0.45 0.45 Finalize

93018 Cardiovascular stress test using maximal or submaximal treadmill or bicycle exercise, continuous electrocardiographic monitoring, and/or pharmacological stress; interpretation and report only 0.30 0.30 Finalize

93308 Echocardiography, transthoracic, real-time with image documentation (2d), includes m-mode recording, when performed, follow-up or limited study 0.53 0.53 Finalize

### CMS-1600-FC 203

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

93653 Comprehensive electrophysiologic evaluation including insertion and repositioning of multiple electrode catheters with induction or attempted indu ction of an arrhythmia with right atrial pacing and recording, right ventricular pacing and recording, his recording with intracardiac catheter ablation of arrhythmogenic focus; with treatment of supraventricular tachycardia by ablation of fast or slow atrioventricularpathway, accessory atrioventricular connection, cavotricuspid isthmus or other single atrial focus or source of atrial re-entry 15.00 15.00 Finalize

93654 Comprehensive electrophysiologic evaluation including insertion and repositioning of multiple electrode catheters with induction or attempted indu ction of an arrhythmia with right atrial pacing and recording, right ventricular pacing and recording, his recording with intracardiac catheter ablation of arrhythmogenic focus; with treatment of ventricular tachycardia or focus of ventricular ectopy including intracardiac electrophysiologic 3d mapping, when performed, and left ventricular pacing and recording, when performed 20.00 20.00 Finalize

93655 Intracardiac catheter ablation of a discrete mechanism of arrhythmia which is distinct from the primary ablated mechanism, including repeat di agnostic maneuvers, to treat a spontaneous or induced arrhythmia (list separately in addition to code for primary procedure) 7.50 7.50 Finalize

93656 Comprehensive electrophysiologic evaluation including transseptal catheterizations, in sertion and repositioning of multiple electrode catheters w ith induction or attempted induction of an arrhythmia with atrial recording and pacing, when possible, right ventricular pacing and recording, his bundle recording with intracardiac catheter ablation of arrhythmogenic focus, with treatment of atrial fibrillation by ablation by pulmonary vein isolation 20.02 20.02 Finalize

93657 Additional linear or focal intracardiac catheter ablation of the left or right atrium for treatment of atrial fibrillation remaining after completion of pulmonary vein isolation (list separately in addition to code for primary procedure) 7.50 7.50 Finalize

93925 Duplex scan of lower extremity arteries or arterial bypass grafts; complete bilateral study 0.80 0.80 Finalize

### CMS-1600-FC 204

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

93926 Duplex scan of lower extremity arteries or arterial bypass grafts; unilateral or limited study 0.50 0.50 Finalize

93970 Duplex scan of extremity veins including responses to compression and other maneuvers ; complete bilateral study 0.70 0.70 Finalize

93971 Duplex scan of extremity veins including responses to compression and other maneuvers; unilateral or limited study 0.45 0.45 Finalize

95017 Allergy testing, any combinati on of percutaneous (scratch, puncture, prick) and intracutane ous (intradermal), sequential and incremental, with venoms, immediate type reaction, including test interpretation and report, specify number of tests 0.07 0.07 Finalize

95018 Allergy testing, any combinati on of percutaneous (scratch, puncture, prick) and intracutane ous (intradermal), sequential and incremental, with drugs or biologicals, immediate type reaction, including test interpretation and report, specify number of tests 0.14 0.14 Finalize

95076 Ingestion challenge test (s equential and incremental ingestion of test items, eg, food, drug or other substance); initial 120 minutes of testing 1.50 1.50 Finalize

95079 Ingestion challenge test (s equential and incremental ingestion of test items, eg, food, drug or other substance); each additional 60 minutes of testing (list separately in addition to code for primary procedure) 1.38 1.38 Finalize

95782 Polysomnography; younger than 6 years, sleep staging with 4 or more additional paramete rs of sleep, attended by a technologist 2.60 2.60 Finalize

95783 Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, with initiation of continuous positive airway pressure therapy or bi-level ventilation, attended by a technologist 2.83 2.83 Finalize

95860 Needle electromyography; 1 extremity with or without related paraspinal areas 0.96 0.96 Finalize

95861 Needle electromyography; 2 extremities with or without related paraspinal areas 1.54 1.54 Finalize

95863 Needle electromyography; 3 extremities with or without related paraspinal areas 1.87 1.87 Finalize

### CMS-1600-FC 205

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

95864 Needle electromyography; 4 extremities with or without related paraspinal areas 1.99 1.99 Finalize 95865 Needle electromyography; larynx 1.57 1.57 Finalize 95866 Needle electromyography; hemidiaphragm 1.25 1.25 Finalize

95867 Needle electromyography; cranial nerve supplied muscle(s), unilateral 0.79 0.79 Finalize

95868 Needle electromyography; cranial nerve supplied muscles, bilateral 1.18 1.18 Finalize

95869 Needle electromyography; thoracic paraspinal muscles (excluding t1 or t12) 0.37 0.37 Finalize

95870 Needle electromyography; limited study of muscles in 1 extremity or non-limb (axial) muscles (unilateral or bilateral), other than thoracic paraspinal, cranial nerve supplied muscles, or sphincters 0.37 0.37 Finalize

95885 Needle electromyography, each extremity, with related paraspinal areas, when performed, done with nerve conduction, amplitude and late ncy/velocity study; limited (list separately in addition to code for primary procedure) 0.35 0.35 Finalize

95886 Needle electromyography, each extremity, with related paraspinal areas, when performed, done with nerve conduction, amplitude and latenc y/velocity study; complete, five or more muscles studied, innervated by three or more nerves or four or more spinal levels (list separately in addition to code for primary procedure) 0.70 0.86 Finalize

95887 Needle electromyography, non-extremity (cranial nerve supplied or axial) muscle(s ) done with nerve conduction, amplitude and latency/velocity study (list separately in addition to code for primary procedure) 0.47 0.71 Finalize

95905 Motor and/or sensory nerve conduction, using preconfigured electrode array(s), amplitude and latency/velocity study, each limb, includes f-wave st udy when performed, with interpretation and report; 0.05 0.05 Finalize

95907 Nerve conduction studies; 1-2 studies 1.00 1.00 Finalize 95908 Nerve conduction studies; 3-4 studies 1.25 1.25 Finalize 95909 Nerve conduction studies; 5-6 studies 1.50 1.50 Finalize 95910 Nerve conduction studies; 7-8 studies 2.00 2.00 Finalize

### CMS-1600-FC 206

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action 95911 Nerve conduction studies; 9-10 studies 2.50 2.50 Finalize 95912 Nerve conduction studies; 11-12 studies 3.00 3.00 Finalize 95913 Nerve conduction studies; 13 or more studies 3.56 3.56 Finalize

95921 Testing of autonomic nervous system function; cardiovagal innervation (parasympathetic function), including 2 or more of the following: heart rate response to deep breathing with recorded r-r interval, valsalva ratio, and 30:15 ratio 0.90 0.90 Finalize

95922 Testing of autonomic nervous system function; vasomotor adrenergic innervation (sympa thetic adrenergic function), including beat-to-beat blood pressure and r-r interval changes during valsalva maneuver and at least 5 minutes of passive tilt 0.96 0.96 Finalize

95923 Testing of autonomic nervous system function; sudomotor, including 1 or more of the following: quantitative sudomotor axon reflex test (qsart), silastic sweat imprint, thermoregulatory sweat test, and changes in sympathetic skin potential 0.90 0.90 Finalize

95924 Testing of autonomic nervous system function; combined parasympathetic and sympathetic adrenergic function testing with at least 5 minutes of passive tilt 1.73 1.73 Finalize

95925 Short-latency somatosensory evoked potential study, stimulation of any/all peripheral nerves or skin sites, recording from the central nervous system; in upper limbs 0.54 0.54 Finalize

95926 Short-latency somatosensory evoked potential study, stimulation of any/all peripheral nerves or skin sites, recording from the central nervous system; in lower limbs 0.54 0.54 Finalize

95928 Central motor evoked potential study (transcranial motor stimulation); upper limbs 1.50 1.50 Interim Final

95929 Central motor evoked potential study (transcranial motor stimulation); lower limbs 1.50 1.50 Interim Final

95938 Short-latency somatosensory evoked potential study, stimulation of any/all peripheral nerves or skin sites, recording from the central nervous system; in upper and lower limbs 0.86 0.86 Finalize

95939 Central motor evoked potential study (transcranial motor stimulation); in upper and lower limbs 2.25 2.25 Finalize

### CMS-1600-FC 207

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

95940 Continuous intraoperative neurophysiology monitoring in the operating room, one on one monitoring requiring personal attendance, each 15 minutes (list separately in addition to code for primary procedure) 0.60 0.60 Finalize

95941 Continuous intraoperative neurophysiology monitoring, from outside the operating room (remote or nearby) or for monitoring of more than one case while in the operating room, per hour (list separately in addition to code for primary procedure) I I Finalize

95943 Simultaneous, independent, qua ntitative measures of both parasympathetic function and sympathetic function, based on time-frequency analysis of hear t rate variability concurrent with time-frequency analysis of continuous respiratory activity, with mean heart rate and blood pressure measures, during rest, paced (deep) breathing, valsalva maneuvers, and head-up postural change C C Finalize

96920 Laser treatment for inflammato ry skin disease (psoriasis); total area less than 250 sq cm 1.15 1.15 Finalize

96921 Laser treatment for inflammato ry skin disease (psoriasis); 250 sq cm to 500 sq cm 1.30 1.30 Finalize

96922 Laser treatment for inflammato ry skin disease (psoriasis); over 500 sq cm 2.10 2.10 Finalize 97150 Therapeutic procedure(s), group (2 or more individuals) 0.65 0.29 Finalize

99485 Supervision by a control physic ian of interfacility transport care of the critically ill or critically injured pediatric patient, 24 months of age or younger, includes two-way communication with transport team before transport, at the referring facility and during the transport, including data interpretation and report; first 30 minutes B B Finalize

99486 Supervision by a control physic ian of interfacility transport care of the critically ill or critically injured pediatric patient, 24 months of age or younger, includes two-way communication with transport team before transport, at the referring facility and during the transport, including data interpretation and report; each additional 30 minutes (list separately in addition to code for primary procedure) B B Finalize

### CMS-1600-FC 208

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action

99487 Complex chronic care coordination services; first hour of clinical staff time directed by a physician or other qualified health care professional with no face-to-face visit, per calendar month B B Finalize

99488 Complex chronic care coordination services; first hour of clinical staff time directed by a physician or other qualified health care professional with one face-to-face visit, per calendar month B B Finalize

99489 Complex chronic care coordination services; each additional 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month (list separately in addition to code for primary procedure) B B Finalize

99495 Transitional care management services with the following required elements: communication (direct contact, telephone, electronic) with the patient and/or caregiver within 2 business days of discharge medical decision making of atleast moderate complexity during the service period face-toface visit, within 14 calendar days of discharge 2.11 2.11 Finalize

99496 Transitional care management services with the following required elements: communication (direct contact, telephone, electronic) with the patient and/or caregiver within 2 business days of discharge medical decision making of high complexity during the service period face-to-face visit, within 7 calendar days of discharge (do not report 90951- 90970, 98960-98962, 98966-98969, 99071, 99078, 99080, 99090, 99091, 99339, 99340, 99358, 99359, 99363, 99364, 99366-99368, 99374-99380, 99441-99444, 99487-99489, 99605-99607 when performed during the service time of codes 99495 or 99496) 3.05 3.05 Finalize

G0127 Trimming of dystrophic nails , any number 0.17 0.17 Finalize G0416 Surgical pathology, gross and microscopic examinations for prostate needle biopsy, any method, 10-20 specimens 3.09 3.09 Finalize

G0452 Molecular pathology procedur e; physician interpretation and report 0.37 0.37 Finalize

### CMS-1600-FC 209

HCPCS

Code Long Descriptor CY 2013 Work RVU CY 2014 Work RVU CY 2014 Action G0453 Continuous intraoperative neurophysiology monitoring, from outside the operating room (remote or nearby), per patient, (attention directed exclusively to one patient) each 15 minutes (list in addition to primary procedure) 0.5 0.6 Finalize

G0455 Preparation with instillatio n of fecal microbiota by any method, including assessment of donor specimen 0.97 1.34 Finalize

G0456 Negative pressure wound therapy, (e.g. vacuum assisted drainage collection) using a mechanically-powered device, not durable medical equipment, including provision of cartridge and dressing(s), topical application(s), wound assessment, and instructions for ongoing care, per session; total wounds(s) surface area less th an or equal to 50 square centimeters C C Finalize

G0457 Negative pressure wound therapy, (e.g. vacuum assisted drainage collection) using a mechanically-powered device, not durable medical equipment, including provision of cartridge and dressing(s), topical application(s), wound assessment, and instructions for ongoing care, per session; total wounds(s) surface area greater than 50 square centimeters C C Finalize

In the following section, we discuss all codes for which we received a comment on the CY 2013 interim final work value or time during the comment period for the CY 2013 final rule with comment period or codes for which we are modifying the work RVU or time. If a code in Table 24 is not discussed in this section, we did not receive any comments on th at code and are finalizi ng the CY 2013 interim final

value. (1) Integumentary System: Skin, Subcutaneous, and Accessory Structures ( CPT code 10120)

As detailed in the CY 2013 final rule with comme nt period, CPT code 10120 had previously been identified as potentially misvalued using the Harvard- valued utilization over 30,000 screen. We assigned

an interim final work RVU of 1.22 for CY 2013, which was slightly less than the AMA RUC-

### CMS-1600-FC 210

recommended value of 1.25. The AMA RUC recomm endation was based upon survey results; however,

we believed an RVU of 1.25 overstated the work of this procedure because some of the activities furnished during the postservice period of the procedur e code overlapped with the E/M visit. The AMA RUC appropriately accounted for the overlap with the E/M visit in its recommendation of preservice time,

but we believed the recommendation failed to account fo r the overlap in the postservice time. To account for this overlap, we used our standard methodology as described above. As noted in the CY 2013 final rule with comment period, we refined the time to equal 3 minutes in the postservice physician time for

CPT code 10120 for CY 2013.

Comment : Commenters urged us to use the AMA RUC -recommended work value of 1.25 RVUs and postservice physician time of 5 minutes for CPT code 10120. Commenters stated that the AMA RUC

conducted extensive review of Medicare claims data for services billed together and after discussing the potential overlap and explicitly dete rmined physician time recommendations that did not include overlap with an E/M service. Since in their view, there was no overlap between the physician time and the E/M service, they recommended that we value the code as recommended by the AMA RUC. Response : After re-review, we maintain that so me of the activities conducted during the postservice time of the procedure code and the E/M vi sit overlap and, therefore, should not be counted twice in developing the procedure’s work value. We continue to believe that the recommended postservice time should be reduced by one-third to acc ount for this overlap. To calculate the time, we reduced the survey’s median postservice time of 5 minutes by one-third, resulting in a reduction from 5 minutes to 3 minutes. As such, we also continue to believe that a work RVU of 1.22 accurately reflects

the work of the service relative to similar services. Therefore, we are finalizing a work RVU of 1.22 for

CPT code 10120 and the time refinement as established for CY 2014. (2) Integumentary System: Skin, Subcutaneous, and Accessory Structures ( CPT codes 11302, 11306, 11310, 11311, 11312, and 11313) For these codes, as we discussed in the CY 2013 fina l rule with comment period, we set the work RVUs at the survey’s 25 th percentile work RVUs as we believed this reflected the appropriate relativity of

### CMS-1600-FC 211

the services both within this family as well as rela tive to other PFS services. As noted in the CY 2013 final rule with comment period, our interim fi nal values differed from the AMA RUC recommendation for CPT codes 11302, 11306, 11310, 11311, 11312 and11313.

Comment: Commenters expressed disappointment with our CY 2013 interim final values for CPT codes 11302, 11306, 11310, 11311, 11312, and 11313, but wit hout providing reasons to support a higher value. Response : We continue to believe that the survey’s 25 th percentile RVUs accurately reflect the work of these procedures relative to each other and re lative to other procedures. Therefore, for CY 2014 we are finalizing the CY 2013 interim final work RVU values for CPT codes 11302, 11306, 11310, 11311, 11312 and 11313. (3) Integumentary System: Repair (Closure) (CPT codes 13132, 13150, 11351, and 13152) 

### For CY 2013, we received new recommendati ons from the AMA RUC for the complex wound repair family, including CPT code s 13132, 13150, 13151, and 13152. As we described in the CY 2013 final rule with comment period, we assigned CY 2013 interim final work RVUs

consistent with AMA RUC recommendations for all the codes in this complex wound repair family, except CPT codes 13150 and 13152, as discu ssed below. We assi gned the following CY 2013 interim final work RVUs: 4.78 for CPT code 13132, 3.58 for CPT code 13150, 4.34 for

CPT code 13151 and 2.38 for CPT code 13153.

Comment : Commenters agreed with our interim final work RVUs of 4.78 for CPT code13132 and 4.34 for CPT code 13151 and thanked us for accepting the AMA RUCrecommendations. Response : We are finalizing wo rk RVUs for CY 2014 of 4.78 for CPT code 13132 and

4.34 for CPT code 13151. The AMA RUC did not provide a recommenda tion for CPT code 13150 for CY 2013 with

### CMS-1600-FC 212

the other codes in the family because it was exp ecting that code to be deleted for CY 2014. As

we noted in the CY 2013 final rule with comm ent period, we believed it was appropriate to reduce the work RVU of CPT code 13150 proportionate to the reductions in work RVUs that the AMA RUC recommended and we adopted for other serv ices in the family, so that we maintained appropriate proportionate rank or der for CY 2013. For the 12 ot her CPT codes in the family, their CY 2012 work RVUs were reduced, on aver age, by 7 percent for CY 2013. Applying that

reduction to the work RVU of CPT code 13150 re sulted in a CY 2013 work RVU of 3.58. We believed that value appropriately reflected the work associated with the procedure and we assigned a CY 2013 interim final work RVU of 3.58 to CPT code 13150. This code will be deleted effective January 1, 2014. As we noted in the CY 2013 final rule with comment period, after reviewing CPT code 13152, we believed that the AMA RUC-recommende d work RVU of 5.34 was too high relative to similar CPT code 13132, which had an AM A RUC-recommended wo rk RVU of 4.78, and CPT code 13151, which had an AMA RUC-recomme nded work RVU of 4.34. We believed that the survey’s 25th percentile wo rk RVU of 4.90 more appropriatel y reflected the relative work involved in furnishing the servi ce. Therefore, we assigned a CY 2013 interim final work RVU

of 4.90 for CPT code 13152.

Comment : Commenters disagreed with our re lative comparison of CPT code 13152 to

CPT codes 13132 and 13151. Comment ers stated that the AMA RUC determined that the survey’s 25th percentile work RVU of 4.90 was too low for CP T code 13152 and would cause a rank order anomaly when compared to the le ss intense CPT code 13132. One commenter cited the detailed rationale that they presented to the AMA RUC explaini ng how CPT code 13152 was more intense and complex to perform than CPT code 13132. Furthermore, commenters

### CMS-1600-FC 213

supported the AMA RUC-recommended direct crosswalk of CPT code 13152 to CPT code 36571, which has a work RVU of 5.34. Commente rs requested that we use the AMA RUCrecommended work RVU of 5.34 for CPT code 13152. Response : Based on comments received, we re-reviewed CPT code 13152 and agree based on the complexity and intensity of the servi ce that CPT code 13152 is more appropriately directly crosswalked to CPT code 36571 which ha s a work RVU of 5.34. Therefore, we are finalizing the AMA RUC-recommended work RVU of 5.34 to CPT code 13152 for CY 2014. (4) Arthrocentesis (CPT Code 20605) In the CY 2013 final rule with comment period, we revised the direct PE inputs for CPT code 20605 (Arthrocentesis, aspiration and/or injection; in termediate joint or bursa (eg, temporomandibular, acromioclavicular, wrist, elbow or ankle, olecranon bu rsa)) and valued the code on an interim final basis

for CY 2013. We had revised the work RVU for this c ode in CY 2012. In CY 2012, when we revised the work RVU, we established a value of 0.68 (76 FR 73 209). However, in CY 2013 due to a data entry error, a work RVU of 0.98 was used for CPT 20605. S ubsequent to the publication of the proposed rule, a stakeholder alerted us to a work RVU discrepancy for this code. The values displayed in Addenda B and C of the CY 2013 final rule with comment period refl ect this error. In this final rule with comment period we are making a technical correction to the work RVU, revising it to 0.68, which is the work value

we established in CY 2012. (5) Musculoskeletal System: Spine (Vertebral Column) (CPT code 22586) CPT code 22586 was created by the CPT Editorial Panel effective January 1, CY 2013. As we noted in the CY 2013 final rule with comment period, after clinical review of CPT code 22586, we believed that a work RVU of 28.12 accurately accoun ted for the work associated with the service and assigned this as the CY 2013 interim final value. The AMA RUC did not provide a recommendation on this service because the specialty societies that woul d have needed to conduct a survey as part of the AMA RUC process declined to do so. We also noted th at a specialty society that does not participate in

### CMS-1600-FC 214

the AMA RUC conducted a survey of its members, who furnish this service, regarding the work and time associated with this procedure and subm itted a work RVU recommendation to CMS. In the CY 2013 final rule with comment period we noted that in determining the appropriate value for this new CPT code, we reviewed the survey r esults and recommendations submitted to us, literature on the procedure, and Medicare claims data. Ultimately, we used a building block approach to value CPT

code 22586. As we stated in the CY 2013 final ru le with comment period, we valued CPT 22586 using

CPT code 22558 as a reference service. CPT code 22 558 is a similar procedure except that it does not include additional grafting, instrumentation, and fi xation that are included in CPT code 22586. To assess the appropriate relative work increase from unbundled CPT code 22558 to the new bundled CPT code 22586, we used Medicare claims data to assess whic h grafting, instrumentation, and fixation services were commonly billed with CPT code 22558. Using these data we created a utilization-weighted work RVU for the grafting component of CPT code 22586, the instrumentation component of the 22586, and the fixation component of 22586. Adding these work RVUs to those of CPT code 22558 created a work RVU of 28.12, which we assigned as the CY 2013 interim final work RVU for CPT code 22586. Additionally, as detailed in the CY 2013 final ru le with comment period, after reviewing the physician time and post-operative vis its for similar services, we concluded that this service includes 40 minutes of preservice evaluation time, 20 minutes of preservice positioning time, 20 minutes of preservice scrub, dress and wait time, 180 minutes of intraservice time, and 30 minutes of immediate postservice time. In the post-operative period, we believed th at this service typically includes 2 CPT code 99231 visits, 1 CPT code 99323 visit, 1 CPT code 99238 visit, and 4 CPT code 99213 visits.

Comment : A commenter opposed our use of the building block methodology to value CPT code 22586, noting that we had used a methodology that digressed from our current standards for valuing procedures. Additionally, the commenter disagreed with our use of data from a specialty society that does not participate in the AMA RUC. Response : To properly value this service without an AMA RUC recommendation, we believe that our evaluation of survey results, recommendations, lite rature, and Medicare claims data is crucial.

### CMS-1600-FC 215

Additionally, as we stated in the methodology section above and in previous final rules with comment periods, we believe the building block methodology is an appropriate approach to develop RVUs. We continue to believe the methodology used to deve lop the CY 2013 interim final work RVU using CPT

code 22588 as the base reference is suitable for this c ode. Furthermore, we believe that the interim final work RVU accurately reflects the work of the ty pical case and reflects the appropriate incremental

difference in work between CPT code 22588 and new CPT code 22586. Therefore, we are finalizing a

work RVU of 28.12 for CPT code 22586 for CY 2014. (6) Elbow Implant Removal (CPT code 24160)

As detailed in the CY 2013 final rule with comment period, we maintained the current work value for CPT code 24160 based upon the AMA RUC recommendation. We received an AMA RUC recommendation for a work RVU of 18.63 based upon a revised CPT code description for this code. We agree with the AMA RUC recommendation and are assigning a CY 2014 interim final work RVU of

18.63 to CPT code 24160.

As detailed in the CY 2013 final rule with comme nt period, in response to comments we received in response to the CY 2012 final rule with comment period, we referred CPT code 29581 to the CY 2012 multi-specialty refinement panel for further review. The refinement panel median work RVU for CPT code 29581 was 0.50. Typically, we finalize the work values for CPT codes after reviewing the results of the refinement panel. However, for CY 2012 we assigned interim RVUs for CPT codes 29581, 29582, 29583, and 29584 and requested additio nal information, with the intention of re-reviewing the services for CY 2013 with the new information we had received, a nd setting interim final values at that time. After consideration of the public comments, refinement panel median value, and our clinical review, we

continued to believe that a work RVU of 0.25 was appropriate for CPT code 29581. We recognized that CPT code 29581 received only editorial changes in CY 2012; however, we continued to believe the HCPAC-reviewed codes 29582, 29 583, and 29584 describe similar services. While the services are performed by different specialties, they do involve simila r work. Therefore, we continued to believe that crosswalking CPT code 29581 to CPT codes 29582, 29583 and 29584 was appropriate and that the

### CMS-1600-FC 216

resulting work RVU accurately reflected the work asso ciated with the service. Accordingly, on an interim final basis for CY 2013, we assigned a work RVU of 0.25 to CPT code 29581; a work RVU of 0.35 to CPT code 29582; a work RVU of 0.25 to C PT code 29583; and a work RVU of 0.35 to CPT code

29584.

Comment : Commenters disagreed with our crosswalk of CPT 29581 to CPT codes 29582, 29583, and 29584. Commenters stated that it was in correct to compare CPT code 29581 to the other codes in the family because the typical patient for CPT 29581, a patient with a recalcitrant venous ulcer, is entirely different and more complex than the typi cal patient for the other codes, and as a result, CPT 29581 is a more intense and time-consuming service. Therefore, commenters requested that we use the

AMA RUC-recommended work RVU of 0.60 for CPT code 29581. Response : After re-review of CPT code 29581, we maintain that a crosswalk to CPT codes 29582, 29583, and 29584 is appropriate because the services involve similar work and as such, should be valued relative to one another. Even though the typi cal patient for CPT code 29581 may be different than CPT codes 29582, 29583, and 29584, th e work associated with the servi ce is not necessarily different. Accordingly, we continue to believe that our r ecommended value accurately reflects the work of the procedure and are finalizing a work RVU of 0.25 for CPT code 29581 for CY 2014. (8) Respiratory System: Accessory Sinuses (CPT code 31231) Previously, CPT code 31231 was identified for review because it was on the multispecialty points of comparison list. We assigned a CY 2013 interim fi nal work RVU of 1.10 to CPT code 31231, which was the survey’s 25 th percentile value and the AMA RUC recommendation. We believed that some of the activities furnished during the preservice and postservice period of the procedure code and the E/M visit overlapped and, therefore, should not be counted tw ice in developing the procedure’s work value. Although we believed the AMA RUC appropriately acc ounted for this overlap in its recommendation of preservice time, we believed they did not account for the overlap in the postservice time. To account for this overlap, we reduced the postservice time by one- third. Specifically, we reduced the postservice time

from 5 minutes to 3 minutes.

### CMS-1600-FC 217

Comment : Although commenters supported the use of the AMA RUC-recommended work RVU, they overwhelmingly disagreed wi th lowering the postservice time for CPT code

31231. Commenters stated that the AMA RUC valued CPT code 31231 through significant

review of Medicare claims data for services billed together and deliberati ons on potential overlap, and determined physician time recommenda tions that did not incl ude overlap with an

E/M service. The commenters stat ed that none of the post-time allo cated to this code overlapped with the E/M service. Therefore, commen ters requested our acceptance of the AMA RUCrecommended postservice physician time of 5 minutes. Response : After re-review, we maintain that so me of the activities conducted during the postservice time of the procedure code and the E/M vi sit overlap and, therefore, should not be counted twice in developing the procedure’s work value. To account for this overlap, we used our standard methodology as described above. Therefore, we are finalizing a refinement of postservice time and a

work RVU of 1.10 for CPT code 31231 for CY 2014. (9) Respiratory System: Trachea and Bronchi (CPT codes 31647, 31648, 31649 and 31651) Effective January 1, 2013, the CPT Editorial Panel created CPT codes 31647, 31648, 31649, and 31651 to replace 0250T, 0251T; and CP T codes 31660 and 31661 to repl ace 0276T and 0277T. As we noted in the CY 2013 final rule with comment period when we valued these codes for the first time, we assigned a work RVU of 4.40 to CPT code 31647; a wo rk RVU of 4.20 to CPT code 31648; and a work RVU of 1.58 to CPT code 31651 on an interim final basis for CY 2013, based upon the AMA RUC

recommendations for these codes.



### Comment : Commenters agreed with our interim final work for these codes and thanked us for accepting the AMA RUC recommendations. Response : We are finalizing work RVUs of 4.40 for CPT code 31647, 4.20 for CPT code

31648 and 1.58 for CPT code 31651 for CY 2014.

### CMS-1600-FC 218

As we noted in the CY 2013 final rule with comment period, after clinical review, we did not agree with the AMA RUC-recommended wo rk RVU of 2.00 for CPT code 31649. Since CPT code 31647 had a higher work RVU than CPT code 31648, we believed that to maintain the appropriate relativity between the services, the add-on code associated with CPT code 31647 (CPT code 31651) should have a higher RVU than the add-on code associated with CPT code 31648 (CPT code 31649). We believed that by valuing CPT code 31649 at the survey’s 25 th 

### percentile work RVU of 1.44, the services were placed in the appropriate rank order. Therefore, we assigned a CY 2013 interim final work RVU of 1.44 to CPT code 31649.

Comment : Commenters urged us to use the AMA RU C-recommended work value of 2.00 for CPT code 31649 and requested that we refer the code to the refinement panel. They noted that proper relativity would have CPT code 3164 9 ranked higher than CPT code 31651 due to the fact that valve removal requires greater physician intensity and complexity compared to insertion. Response : After evaluation of the request for refineme nt, we determined that the criteria for the request for refinement were not met and, as a resu lt, we did not refer CPT code 31649 to the CY 2013 multi-specialty refinement panel for further review.

After re-review of the work RVUs for CPT code 31649 in light of the comments submitted, we maintain that our approach in valuing this procedur e is appropriate. Additionally, during clinical rereview we examined in great detail the physician intensity and complexity involved in CPT code 31649 and believe that the survey’s 25 th percentile work RVU of 1.44 adequately captures these factors. Furthermore, we believe that the CY 2013 interim final work RVU accurately reflects the work of the typical case and reflects the appropriate incremental diffe rence in work with CPT code 31651. Therefore, we are finalizing a work RVU of 1.44 for CPT code 31649 for CY 2014. 

### (10) Respiratory System: Lungs and Pleura (CPT codes 32551 and 32557) We assigned CPT code 32551 a CY 2013 interim final work RVU of 3.29. As we noted in the CY 2013 final rule with comment period, we did not believe that the 0.21 work RVU

### CMS-1600-FC 219

increase recommended by the AM A RUC based upon the survey’s 25 th 

### percentile work RVU of 3.50 was warranted for this service, especially considering the substantial reduction in recommended physician time. Additionally, as we noted in the CY 2013 interim final rule with comment period, we believed that a work RVU of 3.29 placed this se rvice in the appropriate rank

order with the other similar CP T codes reviewed for CY 2013.

Comment : A commenter stated CPT code 32551 shoul d have been assigned a higher work value than we assigned in CY 2013 and request ed that we use the AMA RUC-recommended

work value for the service. The commenter al so pointed out that the work RVU value for 32551 was reduced a few years ago to account for the va st number of percutaneous catheter insertions billed with this code. Because the percutaneous placed catheters, which involve less work, have since been given their own code set, the commen ter stated that the open chest tube insertion would be the only procedure for which CPT code 32551 could be used. As such, the commenter believed that if we accepted the idea that a “prope rly valued code can be split into less complex and intense (percutaneous cathete r insertion) with lesser value and more complex and intense (32551, open thoracostomy) of greater value, [we] would have an appropriate rationale for accepting the RUC recommendations (25th percenti le of the survey, 3.50 RVW) for 32551.” Response : After review of the comments, we conti nue to believe that an increase in work RVU for CPT code 32551 is inapprop riate, especially considering the substantial reduction in the AMA RUC-recommended physician time. Moreove r, we believe that the work RVU of 3.29 accurately reflects the work of th e typical case of this service. Therefore, we are finalizing a

work RVU of 3.29 for CPT code 32551 for CY 2014.

As detailed in the CY 2013 final rule w ith comment period, CPT code 32557 was created as part of a coding restructure for this family. This code was assigned a CY 2013 interim final

### CMS-1600-FC 220

work RVU of 3.12 because we believed the AMA RUC-recommended work RVU of 3.62

overstated the difference between this code and CPT code 32556, which had an AMA RUCrecommended work RVU of 2.50. The specialty societies that surveyed CPT code 32556

recommended to the AMA RUC a work RVU of 3.00 for CPT code 32556 and a work RVU of

3.62 for CPT code 32557. We believed this differe nce of 0.62 in work RVUs between the two codes more accurately captured the relative differe nce between the services. Therefore, since we assigned CPT code 32556 a CY 2013 interim fina l work RVU of 2.50, we believed a work RVU of 3.12 reflected the appropriate diff erence between CPT codes 32556 and 32557 and appropriately reflected the work of CPT code 32557. Additionally, in CY 2013, we refined th e AMA RUC-recommended preservice

evaluation time from 15 minutes to 13 minutes for CPT code 32557 to match the preservice

evaluation time of CPT code 32556.

Comment : Commenters stated that we did not comprehend the relationship between the base code, CPT code 32556, without imaging, and CPT code 32557, with imaging, and the significant clinical differences in providing the services. Commenters disagreed with the way we

determined the work RVU for CPT 32557 and stat ed that a better alternative for valuing CPT

code 32557 would have been to add the value of CT guidance (1.19) to the non-image guided code (CPT code 32556 at 2.50 RVUs) to achieve the AMA RUC-recommended work RVU of 3.62. Therefore, commenters requested our use of the AMA RUC-recommended work value of 3.62 for CPT code 32557 and refinement panel review of the code. Response : After evaluation of the request for refinement, we determined that the criteria for the request for refinement were not met and, as a result, we did not refer CPT code 32557 to the CY 2013 multi-specialty refineme nt panel for further review.

### CMS-1600-FC 221

After re-review of CPT code 32557, we mainta in that our approach in valuing this procedure is appropriate since the AMA RU C-recommended work RVU of 3.62 overstates the

difference between CPT codes 32556 and 32557. We c ontinue to believe that the difference in work RVUs presented to the AMA RUC by the sp ecialty societies that surveyed CPT code 32557 is more appropriate in order to maintain relativity among the codes. Therefore, we are finalizing the refinement to time and the wo rk RVU of 3.12 for CPT code 32557 for CY 2014. (11) Respiratory System: Lungs and Pleura (CPT codes 32663, 32668, 32669, 32670, 32671, 32672, and 32673) The CPT Editorial Panel reviewed the lung resection family of codes and deleted 8 codes, revised 5 codes, and created 18 new codes for CY 2012. As detailed in the CY 2012 final rule with comment period, during our review for the CY 2012 PFS final ru le with comment period, we were concerned with the varying differentials in the AMA RUC-recommend ed work RVUs and times between some of the open surgery lung resection codes and their endoscopic an alogs. Rather than assign alternate interim final RVUs and times in this large restructured family of codes, we accepted the AMA RUC recommendations on an interim basis for CY 2012 and requested that the AMA RUC re-review the surgical services along with their endoscopic analogs. In the CY 2012 PFS final rule with comment peri od we made this request. However, there was an inadvertent typographical error in our request, in that we referred to “open heart surgery analogs” instead of just “open surgery analogs” for each code . For example, we stated, “For CPT code 32663 (Thoracoscopy, surgical; with lobectomy (single lobe)), the AMA RUC recommended a work RVU of 24.64. Upon clinical review, we have determined that it is most appropriate to accept the AMA RUCrecommended work RVU of 24.64 on a provisional basis, pending review of the open heart surgery analogs, in this case CPT code 32480. We are requesting the AMA RUC look at the incremental difference in RVUs and times between the open and laparoscopic surgeries and recommend a consistent

valuation of RVUs and time for C PT code 32663 and other services within this family with this same

### CMS-1600-FC 222

issue. Accordingly, we are assigning a work RVU of 24.64 for CPT code 32663 on an interim basis for CY 2012” (76 FR 73195). During the comment period on the CY 2012 final rule with comment period, the affected specialty societies and the AMA RUC re sponded to our request noting that the codes were not open heart surgery codes. In the CY 2013 final rule with comment period, we acknowledged that our request would have been more clear if we had referred to “open surger y codes” instead of “open heart surgery codes” and if we had written “endoscopic procedures” instead of “lapar oscopic surgeries.” With this clarification, we re-requested public comment on the appropriate work RVUs and time values for CPT codes 32663 and 32668-32673. For CY 2013, we maintained the follo wing CY 2012 interim final values for these services

as shown in Table 24.

Comment : A commenter stated that there was no a pparent correlation between the endoscopic and open variations of the proce dures and added that no further effort was needed to determine differences between the two approaches because “any such relationship woul d be spurious at best.” The

commenter also stated that additional “exercises to establish consistent differences in work value according to surgical approach (when such relationshi ps actually do not exist for clinical reasons)” are

unnecessary. 

### Response : We continue to believe that our re quest for additional information on the relationship between open and e ndoscopic procedures was warrant ed. Because we received no additional information on this family, as request ed, we are finalizing our CY 2013 interim final values for this family. (12) Cardiovascular System: Heart and Pericar dium (CPT codes 33361, 33362 , 33363, 33364, 33365, 33367, 33368, 33405, 33430, and 33533)

As detailed in the CY 2013 final rule with comme nt period, the CPT Editorial Panel deleted four Category III codes (0256T through 0259T) and created nine CPT codes (33361 through 33369) to report transcatheter aortic valve replacement (TAVR) procedures for CY 2012.

### CMS-1600-FC 223

Like their predecessor Category III codes (0256T-0 259T), the new Category I CPT codes 33361 through 33365 require the work of an interventiona l cardiologist and cardiothoracic surgeon to jointly participate in the intra-operative technical aspect s of TAVR as co-surgeons. Claims processing instructions for the Coverage with Evidence Development (CED) (CR 7897 transmittal 2552) requires each physician to bill with modifier -62 indicating that the co-surgery payment applies. In this situation, Medicare pays each co-surgeon 62.5 percent of the fee schedule amount. The three add-on cardiopulmonary bypass support services (CPT codes 33367, 33368, and 33369) are only reported by the cardiothoracic surgeon; therefore the AMA RUC-reco mmended work RVUs for those services reflected only the work of one physician. The AMA RUC-re commended work RVUs for each of the co-surgery CPT codes (33361 through 33365) reflect the combined work of both physicians without any adjustment to reflect the co-surgery payment policy. As we noted in the CY 2013 final rule with comment period, we considered whether it was appropriate to continue our co-surgery payment policy at 62.5 percent of the physician fee schedule amount for each physicia n for these codes if the work value reflected 100 percent of the work for two physicians. Ultimately, we decided to set the work RVU values to reflect the total work of the procedures, and to continue to fo llow our co-surgery payment policy, which allows the services to be billed by two physicians in part b ecause this was part of the payment policy established

with the CED decision. 

### As we noted in the CY 2013 final rule with comment period, after clinical review of CPT code 33361, we believed that the survey’s 25th percentile work RVU of 25.13 appropriately captured the total work of the service. The AMA RUC recommended the survey’s median work RVU of 29.50. Regarding physician time, for CPT 33361, as well as CPT codes 33362 through 33364, we believed 45 minutes of pr eservice evaluation time, which was the survey median time,

was more consistent with the work of this service than the AMA RUC-recommended preservice evaluation time of 50 minutes. Accordingly, we assigned a work RVU of 25.13 to CPT code

### CMS-1600-FC 224

33361, with a refinement of 45 minutes of preservi ce evaluation time, on an interim final basis

for CY 2013. As we explained in the CY 2013 interim fina l rule with comment period, after clinical review of CPT code 33362, we believed that th e survey’s 25th per centile work RVU of 27.52 appropriately captured the total work of the serv ice and assigned an interim final work RVU of 27.52. The AMA RUC recommended the survey median work RVU of 32.00. As with CPT code 33361, we believed 45 minutes of preservice evaluation time wa s more appropriate for this service than the AMA RUC recommended preser vice evaluation time of 50 minutes. We therefore refined the preservice evaluation time to 45 minutes.

As we noted in the CY 2013 interim final rule with comment period, af ter clinical review of CPT code 33363, we believed that the su rvey’s 25th percentile work RVU of 28.50 appropriately captured the total work of the serv ice and assigned an interim final work RVU of 28.50. The AMA RUC recommended the survey median work RVU of 33.00. As with CPT codes 33361 and 33362, we believed 45 minutes of preservice evaluation time was more appropriate for this service than the AMA RUC recommended time of 50 minutes and we therefore refined the preservice evaluation time to 45 minutes.

As we noted in the CY 2013 final rule with comment period, after clinical review of CPT code 33364, we believed that the survey’s 25th percentile work RVU of 30.00 more appropriately captured the total work of the service than the AMA RUC-recommended survey median work RVU of 34.87, and therefore, we es tablished an interim final work RVU of 30.00. As with CPT codes 33361-33363, we also believed 45 minutes of preservice evaluation time was more appropriate for this service than th e AMA RUC-recommended time of 50 minutes, and therefore, we refined the preser vice evaluation time 45 minutes.

### CMS-1600-FC 225

As we noted in the CY 2013 final rule with comme nt period, after clinical review of CPT code 33365, we believed a work RVU of 33.12 accurately refl ected the work associated with this service rather than the survey’s median work RVU of 37.50. We de termined that the work asso ciated with this service was similar to reference CPT code 33410, which has a work RVU of 46.41 and has a 90-day global period that includes inpatient hospital and office vi sits. Because CPT code 33365 had a 0-day global period that does not include post-operative visits, we calculated the value of the pre-operative and postoperative visits in the global period of CPT code 33 410, which totaled 13.29 work RVUs, and subtracted

that from the total work RVU of 46.41 for CPT code 33410 to determine the appropriate work RVU for CPT code 33365. With regard to time, we used the 50 minutes of preservice evaluation time because we believed that the procedure described by CPT code 33365 involves more preservice evaluation time than 33410 since it was performed by surgically opening the chest via median sternotomy. Accordingly, we assigned an interim final work RVU of 33. 12 for CPT code 33365 for CY 2013.

Comment : Commenters disagreed with our use of the 25 th percentile survey values for CPT codes

33361-33365 rather than the AMA RUC-recommended me dian survey values. Commenters stated that our valuation of CPT code 33365 was arbitrary and re sulted in considerably undervalued work RVUs. They also asserted that our interim final work RVUs produced rank order anomalies, were inconsistent with the high level of intensity and complexity necessitated by the procedures, and undervalued the procedures for each physician. Additionally, comm enters provided examples comparing the AMA RUC

recommendations and the interim final work RVUs fo r CPT codes 33361-33365 to other codes that were recently valued. In providing the examples, commenters made an effort to demonstrate that, by comparing CPT codes 33361-33365 to active comparable CPT codes and through proration of the physician time, it was apparent that the work RVUs for CPT c odes 33361-33365 should be increased. Commenters therefore requested we use the AMA RUC-recomme nded work values of 29.50 for CPT code 33361, 32.00 for CPT code 33362, 33.00 for CPT code 33363, 34.87 for CPT code 33364 and 37.50 for CPT

code 33365 and submit the code series to the refinement panel for review.

### CMS-1600-FC 226

Response : After evaluation of the request for refineme nt, we determined that the criteria for the request for refinement were not met and, as a result, we did not refer CPT codes 33361-33365 to the CY 2013 multi-specialty refinement panel for further review.

After consideration of the comments on CPT cod es 33361-33365, we maintain that our approach in valuing these procedures is appropriate. We believe that the AMA RUC-recommended work RVUs overstate the intensity and physicia n time in this family. We also believe that setting the work RVU

values of these services to reflect the total work of the procedures is appropriate. This decision is also consistent with our co-surgery payment policy, which allows the services to be billed by two physicians. While many commenters objected to this rationale, we believe that their comparisons of CPT codes 33361-33365, services that require the work of two ph ysicians, to codes where only one physician is performing the work are inappropriate. We continue to believe that the interim final work RVUs that we

established in the CY 2013 final rule with comment period accurately reflect the work of the typical case of this service. Therefore, for CY 2014, we are fi nalizing the interim final work RVUs for CPT codes 33361-33365. We are also finalizing the following refinements to time for CY 2014: 45 minutes of preservice evaluation for CPT codes 33361- 33364; an d 50 minutes of preservice evaluation for CPT code

33365. 

### Comment : Commenters specifically agreed with our interim final work RVUs of 11.88 for

CPT code 33367 and 14.39 to CPT code 33368 a nd thanked us for using the AMA RUC

recommendations. Response : We are finalizing the work RVUs of 11.88 to CPT code 33367 and 14.39 to CPT code

33368 for CY 2014.

As detailed in the CY 2013 final rule with comment period, CPT codes 33405, 33430, and 33533 were previously identified as potentially misvalued th rough the high expenditure procedure code screen. When reviewing the services, the specialty society u tilized data from the Society of Thoracic Surgeons (STS) National Adult Cardiac Database in devel oping recommended times and work RVUs for CPT

### CMS-1600-FC 227

codes 33405, 33430 and 33533 rather than conducting a su rvey of work and time. After reviewing the mean procedure times for the services in the STS data base alongside other information relating to the value of the services, the AMA RUC concluded that CPT codes 33405 and 334 30 were appropriately valued and, accordingly, the CY 2012 RVUs of 41.32 for CPT code 33405, and 50.93 for CPT code 33430 should be maintained, and that the work associ ated with CPT code 33553 had increased since the

service was last reviewed. The AMA RUC recommended a work RVU of 34.98 for CPT code 33533,

which is a direct crosswalk to CPT code 33510.

As we noted in the CY 2013 final rule with comment period (77 FR 69049), we believed the STS database, which captures outcome data in addition to time and visit data, is a useful resource in the valuation of services. However, we remain interest ed in additional data from the STS database that might help provide context to the reported informa tion. The AMA RUC recommendations on the services showed only the STS database mean time for CPT cod es 33405, 33430, and 33533. We noted in the CY 2013 final rule with comment period that we were inte rested in seeing the distribution of times for the 25 th percentile, median, and 75 th percentile values, in addition to any other information STS believed would be

relevant to the valuation of the services. For CY 2013, we assigned interim final work RVUs for the services, pending receipt of additional time data. Specifically, we maintained the CY 2012 work RVU values of 41.32 for CPT code 33405; 50.93 for C PT code 33430; and 33.75 for CPT code 33533.

Comment : STS requested a higher work value of CPT code 33533 and also disagreed with the AMA RUC recommendation. In its opinion, “the RU C recommendation is not consistent with the process and alters the intensity of 33533 contrary to the RUC rationale.” In contrast, the AMA RUC

stated that the AMA RUC work value recommendation was most appropriate and asked that we submit the code for refinement panel review. In response to our request for additional inform ation regarding times from the STS database, all commenters declined to provide further information, st ating that sufficient time data and explanations for the methodology associated with utilization of the database were provided to both the AMA RUC and CMS. STS further expressed its disinterest in pr oviding additional information by noting that the

### CMS-1600-FC 228

supplementary data that we requested, the median or 25 th percentile statistical descriptors, would “systematically exclude known physician work from c onsideration in code valuation, and if utilized would result in undervaluation relative to the remainder of the Physician Fee Schedule.” Response : After evaluation of the request for refineme nt, we determined that the criteria for the request for refinement were not met and, as a resu lt, we did not refer CPT code 33533 to the CY 2013 multi-specialty refinement panel for further review. After re-review of CPT codes 33405, 33430 and 33533, we maintain that our approach in valuing these procedures is appropriate. In the CY 2013 fina l rule with comment period, we expressed our

concern with the data derived from the STS database and our desire to receive additional information regarding the distribution of times a nd varying RVUs, for the 25th per centile, median, and 75th percentile values, in order to better value the services. We di d not receive additional information from either STS or the AMA RUC regarding these procedures. In the absen ce of this information, we continue to believe

that the CY 2013 interim final work RVUs for CPT codes 33405, 33430 and 33533 reflect the work of the typical case of these services. Therefore, we are finalizing the work RVUs of 41.32 for CPT code 33405,

50.93 for CPT code 33430 and 33.75 for CPT code 33533 for CY 2014. (13) Cardiovascular System: Arteries and Veins (CPT codes 35475, 35476, 36221-36227) In the CY 2013 final rule with comment period, after clinical review of CPT code 35475, we established a work RVU of 5.75 to appropriately capture the work of the service. The AMA RUC, rather than using the survey, used a building block appro ach based on comparison CPT code 37224, which has a work RVU of 9.00, and recommended a work RVU of 6.60. The AMA RUC acknowledged that CPT code 35475 was typically reported with other services. We determined that the appropriate crosswalk for this code was CPT code 37220, whic h has a work RVU of 8.15. After accounting for overlap with other services, we determined that a work RVU of 5.75 was appropriate for the service. Accordingly, we assigned a work RVU of 5.75 to CPT code 35475 on an interim final basis for CY 2013. After clinical review of CPT code 35476, we assi gned a work RVU of 4.71 to the service in the CY 2013 final rule with comment period. The AMA RUC had recommended a work RVU of 5.10, based

### CMS-1600-FC 229

on the survey’s 25 th percentile value. We determined that the work associated with CPT code 35476 was similar in terms of physician time and intensity to CPT code 37191, which had a work RVU of 4.71. We believed the work RVU of 4.71 appropriately captured the relative difference between the service and CPT code 35475. Therefore, we assigned a work RVU of 4.71 for CPT code 35476 on an interim final basis

for CY 2013.

Comment : Commenters universally disagreed with our reference codes for CPT codes 35475 and 35476. They stated that our comparison of CPT c ode 35475 to CPT code 37224 did not fully consider intensity or complexity of CPT code 35475, such as the need for a physician to perform catheter manipulation or traverse multiple vessels. They also stated that our comparison of CPT code 35476 to CPT code 37220 was inappropriate because the latter pr ocedure was related to a service in a lower flow vein and, thus, using this crosswalk did not account for the service’s work intensity or complexity, including the risk associated with angioplasty. Commenters believed that the comparison codes utilized by the AMA RUC in its recommended valuation, CP T codes 37224 and 37220, had a more comparable level of difficulty to CPT codes 35475 and 35476, resp ectively, than the codes we used. Additionally, commenters were concerned on a broader policy basis that the interim final values would compromise both the vascular access care provided to chronic kidn ey disease patients and specialty programs. For those reasons, commenters requested our use of the AMA RUC-recommended work RVUs of 6.60 for

CPT code 35475 and 5.10 for CPT code 35476 and refinement panel review of the codes. Response : We referred CPT codes 35475 and 35476 to the CY 2013 multi-specialty refinement panel for further consideration because the requirement s for refinement panel review were met. The refinement panel median work RVU for CPT codes 35475 and 35476 were 6.60 and 5.10, respectively. After reevaluation, we are finalizing work RVUs of 6.60 for CPT code 35475 and 5.10 for CPT code 35476, based upon the refinement panel median. In the CY 2013 final rule with comment pe riod we assigned CPT code 36221 an interim final work RVU of 4.17 and refined the postservice to 30 minutes. The AMA RUC recommended a work RVU of 4.51 and a postservice time of 40 minutes using a direct crosswalk to the two component codes being

### CMS-1600-FC 230

bundled, CPT code 32600, which has a work RVU of 3.02, and CPT code 75650, which has a work RVU

of 1.49. As we noted in the CY 2013 final rule w ith comment period, we believed that that there were efficiencies gained when services were bundled and that crosswalking to the work RVU of CPT code 32550, which had a work RVU of 4.17, appropriately accounted for the physician time and intensity with CPT code 36221. Additionally, we believed that the survey’s postservice time of 30 minutes more accurately accounted for the time involved in fu rnishing the service than the AMA RUC-recommended postservice time of 40 minutes. In the CY 2013 final rule with comment period we noted that after clinical review of CPT code 36222, we believed the survey 25 th percentile work RVU of 5.53 appropriately captured the work of the service, particularly the efficiencies when two services were bundled together. The AMA RUC recommended the survey median work RVU of 6.00. Like CPT code 36221, we believed the survey’s postservice time of 30 minutes was more appropriate than the AMA RUC-recommended postservice time of 40 minutes. We assigned a work RVU of 5.53 with refinement to time for CPT code 36222 as interim

final for CY 2013. In the CY 2013 final rule, we noted that after c linical review of CPT code 36223, we assigned an interim final work RVU value of 6.00, the survey’s 25 th percentile value, because we believed it appropriately captured the work of the service, partic ularly efficienci es when two services were bundled together. The AMA RUC reviewed the survey results, and after a comparison to similar CPT codes, recommended a work RVU of 6.50. Like many othe r codes in the family, we believed the survey’s postservice time of 30 minutes was more appropria te than the AMA RUC-recommended time of 40 minutes and refined the time accordingly. In the CY 2013 final rule, we noted that after cl inical review of CPT code 36224, we believed a work RVU of 6.50, the survey’s 25 th percentile value, appropriately captured the work of the service, particularly, efficiencies when two services were bundled together. We believed 30 minutes of postservice time more appropriately accounted for the work of the service. The AMA RUC reviewed the survey results, and after a comparison to similar CPT codes, recommended a value of 7.55 and a postservice time

### CMS-1600-FC 231

of 40 minutes for CPT code 36224. Accordingly, we assigned a work RVU of 6.50 with refinement to

time for CPT code 36224 as interim final for CY 2013. In the CY 2013 final rule, we noted that after cl inical review of CPT code 36225, we believed it should be valued the same as the CPT code 36223, which was assigned an interim final work RVU of 6.00. Comparable to CPT code 36223, we also believed 30 minutes of postservice time more appropriately

accounted for the work of the se rvice and refined the time accordin gly. The AMA RUC reviewed the survey results and recommended the survey’s medi an work RVU of 6.50 and a postservice time of 40

minutes for CPT code 36225. In the CY 2013 final rule (77 FR 69051), we noted that after clinical revi ew of CPT code 36226, we believed it should be valued the same as CPT code 36224, which was assigned work RVU of 6.50. Comparable to CPT code 36224, we believed 30 minute s of postservice time more appropriately accounted

for the work of the service. The AMA RUC reviewed the survey results, and after a comparison to similar CPT codes, recommended a value of 7.55 and a postservice time of 40 minutes for CPT code 36226. We assigned a work RVU of 6.50 with refinement to time for CPT code 36226 as interim final for CY 2013. In the CY 2013 final rule, we noted that after cl inical review of CPT c ode 36227, we determined that efficiencies were gained when services were bundled, and identified a work RVU of 2.09 for the service. A 2.09 work RVU reflected the application of a very conservative estimate of 10 percent for the work efficiencies that we expected to occur when multiple component codes were bundled together to the sum of the work RVUs for the component codes. Th e AMA RUC reviewed the survey results, and after a comparison to similar CPT codes, recommended a value of 2.32 for CPT code 36227. The AMA RUC used a direct crosswalk to the two component cod es being bundled, CPT code 36218, which has a work RVU of 1.01, and CPT code 75660, which has a wo rk RVU of 1.31. We assigned a CY 2013 interim

final work RVU of 2.09.

Comment : Commenters stated that the AMA RUC-reco mmended work RVUs captured all of the efficiencies that were achieved by bundling the ser vices and that our conclusion that these codes values

should further be lowered was uns upported and would produce rank or der anomalies among intervention

### CMS-1600-FC 232

services. Some stated that for CPT codes 36222, 36223, 36224, 36225 and 36226, the AMA RUCrecommended values represented a considerable savings to the Medicare system. Commenters acknowledged that it may be true that efficiencies occur when surgical codes are bundled with other surgical codes or radiologic supervision and interpre tation (S&I) codes are bundled with other S&I codes. However, commenters stat ed that CPT codes 36221 and 36227 reflects the bundling of surgical codes with S&I codes and, that since the activities of surgi cal codes and S&I codes are, by definition, separate, they disagreed that efficiencies should be assumed. Fu rthermore, commenters stated that it was incorrect for us to directly crosswalk to other procedures, such as CPT codes 32550, 36251 and 36253, which are easier in nature and entail less risk and less image inte rpretation, when more parallel crosswalks existed. As such, commenters supported the direct crossw alks and the following recommended work RVUs provided by the AMA RUC: 4.51 for CPT code 36 221, 6.00 for CPT code 36222, 6.50 for CPT code 36223, 7.55 for CPT code 36224, 6.50 for CPT code 36225, 7.55 for CPT code 36226 and 2.32 for CPT code 36227 and requested refinement panel review of the codes. Response : After evaluation of the request for refineme nt, we determined that the criteria for therequest for refinement were not met and, as a result, we did not refer the codes to the CY 2013 multispecialty refinement panel for further review. After re-review of CPT codes 36221-36227, we main tain that the recommended direct crosswalks for these services are appropriate because the codes invol ve similar work and, as such, should be valued relative to one another. We also disagree with the commenters that effici encies do not occur when surgical codes and S&I codes are bundled. Therefore, we are finalizing the CY 2013 interim final values

for CY 2014 for CPT codes 36221-36227. We are also finalizing the postservice time refinement of 30

minutes to CPT codes 36221-36226 for CY 2014. (14) Cardiovascular System: Arteries and Veins (CPT codes 37197 and 37214)

As we noted in the CY 2013 final rule with co mment period, we crosswalked the physician time and intensity of CPT code 36247 to CPT code 37197, resulting in a CY 2013 interim final work RVU of

6.29 for CPT code 37197. The AMA RUC had recommende d a work RVU of 6.72 for CPT code 37197.

### CMS-1600-FC 233

For the CY 2013 final rule with comment period, we assigned an interim final work RVU of 2.74 to CPT code 37214. In making its recommendation, the AMA RUC reviewed the survey results, and after a comparison to similar CPT codes, recommended a work RVU of 3.04 to CPT code 37214. After clinical review, we determined that there were efficiencies gained when services were bundled and ultimately used a very conservative estimate of 10 per cent for the work efficienci es we expected to occur when multiple component codes were bundled. Sp ecifically, we decreased the AMA RUC-recommended work RVU value of 3.04 by 10 percent to produce th e work RVU value of 2.74, which we assigned as the

CY 2103 an interim final work RVU for CPT code 37214.

Comment : Commenters disagreed with these interim fi nal values and suggested that we finalize

the AMA RUC-recommended work RVUs of 6.72 for CPT code 37197 and 3.04 for CPT code 37214 because the services are more intense and complex than accounted for by the CY 2013 interim final values. Additionally, several commenters alerted us to our oversight in not providing a written rationale

for our work RVU values for CPT codes 37197 and 37214 and as result, requested a technical correction. Response : The commenters are correct that we did not include a rationale to explain how we

reached the interim final work va lues for these codes in the CY 2013 fi nal rule with comment period. However, Table 30 “Work RVUs for CY 2013 New, Re vised and Potentially Misvalued Codes” in the CY 2013 final rule with comment period clearly identi fied the interim final values being assigned to these

codes. It also included the AMA RUC recommendations , denoted whether we agreed with the AMA RUC recommendations, and indicated whether we refine d the times recommended by the AMA RUC. Based upon the comments received, we re-review ed CPT codes 37197 and 37214. Based upon our review, we believe that directly crosswalking CPT code 37197 to CPT code 36247 and reducing CPT code 37214 by a conservative 10 percent to account for efficiencies gained when services are bundled are appropriate to establish values for these services and produ ce RVUs that fully reflect the typical work and intensity of the procedures. Therefore, we are fi nalizing the work RVU of 6.29 for CPT code 37197 and

2.74 for CPT code 37214 for CY 2014. (15) Hemic and Lymphatic System: General (CPT codes 38240 and 38241)

### CMS-1600-FC 234

In the CY 2013 final rule, we noted that afte r review, we believed C PT code 38240 should have

the same work RVU as CPT code 38241 because the two services involved the same amount of work.

The AMA RUC recommended a work RVU of 4.00 for CPT code 38240 and 3.00 for CPT code 38241. On an interim final basis for CY 2013 we assigned CPT code 38240 a work RVU of 3.00 and agreed with

the AMA RUC recommendation of 3.00 for CPT code 38241.

Comment : Commenters specifically opposed our comparison of work for CPT code 38240 to CPT code 38241, stating that CPT code 38240 was mu ch more complicated, intense and time consuming than CPT code 38241 and, as a result, should have a higher work RVU. Commenters also indicated that CPT 38240 has become more difficult to perform in r ecent years. Therefore, commenters requested that

we use the AMA RUC-recommended work RVU of 4. 00 for CPT code 38240 and maintain the interim

final value of RVU of 3.00 for CPT code 38241. Comm enters asked that both codes be referred to the refinement panel. Response : After evaluation of the request for refineme nt, we determined that the criteria for the request for refinement were not met and, as a result, we did not refer CPT codes 38240 and 38241 to the CY 2013 multi-specialty refinement panel for further review. Based on comments received, we re-reviewed the c odes and agree that CPT code 38240 is a more involved and intense procedure than CPT code 38241 and as a result, should have a higher RVU valuation

for work than the CY 2013 interim final work RVU. Therefore, we are finalizing the AMA RUCrecommended work RVU for 4.00 to CPT code 38 240 and 3.00 for CPT code 38241 for CY 2014. (16) Digestive System: Lips (CPT code 40490)

As detailed in the CY 2013 final rule with co mment period, we assigned an interim final work RVU of 1.22 to CPT code 40490, as recommended by the AMA RUC.

Comment : Commenters agreed and expressed appreciation with our use of the AMA RUCrecommended value. Response : We are finalizing a work RVU of 1.22 for CPT code 40490 for CY 2014. (17) Gastrointestinal (GI) Endoscopy (CPT codes 43206 and 43252)

### CMS-1600-FC 235

As detailed in the CY 2013 final rule with comment period, CPT codes 43206 and 43252 were contractor priced on an interim final basis. As part of its review of all gastrointestinal e ndoscopy codes, we received

recommendations from the AMA RUC for a work RVU of 2.39 for CPT code 43206 and 3.06 for CPT code 43252. Based upon these recommendations we have the data necessary to establish RVUs and so are assigning CY 2014 interim final work RVUs of 2.39 for CPT code 43206 and 3.06 for CPT code

43252.

As detailed in the CY 2013 final rule with co mment period, we assigned an interim final work RVU of 3.20 to CPT code 52287 as recommended by the AMA RUC.

Comment : A specialty association disagreed with our use of the AMA RUC work RVU

recommendation for CPT code 52287. The commenter supported the survey’s use of CPT code 51715 as the key reference code for this service, but stated that CPT code 52287 should have, at a minimum, the

same RVU as CPT code 51715 becau se CPT code 52287 requires more injections and, as a result, a higher level of technical skill and more time. Therefor e, the commenter requested that we accept a work

RVU recommendation of 3.79 for CPT code 52287. Response : After re-review of CPT code 52287, we ma intain that our interim final value based upon the AMA RUC recommendation is appropriate. We note that the key reference service CPT code 51715 has more intraservice time (45 minutes) than CPT code 52287 (21 minutes), contrary to the

commenter’s assertion. We continue to believe that a RVU of 3.20 accurately and fully captures the work required for this service. Therefore, we are finaliz ing a work RVU of 3.20 for CPT code 52287 for CY

2014. (19) Urinary System: Bladder (CPT code 52353) We assigned a CY 2013 interim final work RVU of 7.50 for CPT code 52353. As detailed in the CY 2013 final rule with comment period, after clini cal review, we determined that the survey’s 25th percentile work RVU represented a more appropria te incremental difference over the base code, CPT code 52351, than the AMA RUC-recommended work RVU of 7.88. Additionally, we believed the survey

### CMS-1600-FC 236

25th percentile work RVU more appropriately accounted for the significant reduction in intraservice time

from the current value.

Comment : Commenters objected to our reduction in the work RVU from the CY 2012 value and

stated that we should use the AM A RUC-recommended work RVU of 7.88 . Commenters said that the skills, effort, and time of CPT 52353 were more inten se than those of CPT code 52351 and our value did not provide the fully warranted differential between the two codes. Additionally, commenters initially requested refinement panel review of CPT c ode 52353, but later withdrew their request. Response : Based on comments received, we re-reviewed CPT code 52353 and co ntinue to believe that our interim final work value is appropr iate. We maintain that the survey’s 25 th percentile work RVU appropriately accounts for the work of this servi ce, especially given the significant reduction in

intraservice time and the lack of evidence that .the intensity of this procedure has increased. We also believe that the interim final work value appropria tely provides an incremental difference over the base CPT code 52351. For these reasons, we are finalizi ng a work RVU of 7.50 to CPT code 52353 for CY

2014.

(20) Nervous System: Extracranial Nerves, Peri pheral Nerves, and Autonomic Nervous System (CPT code 64615) The CPT Editorial Panel created CPT code 64615 effective January 1, 2013. The AMA RUC

recommended a work RVU of 1.85 and we agreed with the recommendation. The AMA RUC also requested a decrease in the global period from 10 days to 0 days. As we noted in the CY 2013 final rule, we assigned CPT 64615 a global period of 10 days to maintain consistency within the family of codes.

Comment : Commenters stated that the assigned 10-day global period was not appropriate because there are no E/M post-operative visits relate d to the service, and accordingly, a 0-day global period would correctly reflect the work involved in , and valuation of, the service. Additionally, commenters noted that the 10-day global period was inc onsistent with the 0-day global period we adopted

### CMS-1600-FC 237

for other services within the family. Commenters requested that we accept the AMA RUC-recommended global period of 0 days. Response : Based on comments received, we re-reviewed CPT code 64615 and co ntinue to believe that a 10-day global period is appropriate. Given that most of the other services within this family of CPT codes also have 10-day global periods, we continue to believe that a 10-day global period is appropriate

for CPT code 64615. Furthermore, while there are other chemodenerveration codes in other areas of the body that do have 0-day global peri ods, we continue to believe that a 10-day global period for CPT code 64615 is appropriate in this anatomical region. Ther efore, we are finalizing the work RVU of 1.85 for CPT code 64615, with a 10-day global period, for CY 2014. (21) Eye and Ocular Adnexa: Eyeball (CPT code 65222) CPT code 65222 was identified as potentially mi svalued under the Harvard-valued utilization over 30,000 screen. As we noted in the CY 2013 fina l rule with comment period, we assigned a work RVU of 0.84 to CPT code 65222, as well as a re finement to the AMA RUC-recommended time.

Medicare claims data from 2011 indicated that CPT co de 65222 was typically furnished to the beneficiary on the same day as an E/M visit. We believed that some of the activities furnished during the preservice and postservice period overlapped with the E/M vi sit. We did not believe that the AMA RUC appropriately accounted for this overlap in its r ecommendation of preservice and postservice time. To account for this overlap, we reduced the AMA RUC-recommended preservice evaluation time by onethird, from 7 minutes to 5 minutes, and the AMA RUC -recommended postservice time by one-third, from

5 minutes to 3 minutes. We believed that 5 minutes of preservice evaluation time and 3 minutes of postservice time accurately reflected the time involve d in furnishing the preservice and postservice work of the procedure, and that those times we re well-aligned with similar services.

Comment : Commenters disagreed with our work RVU and time refinement for CPT code 65222, stating that they were arbitrary in nature and b ased on an incorrect assumption that the overlap between the E/M visit and the preservice and postservice peri ods were not properly accounted for in the AMA

RUC recommendation. Commenters stated that the AM A RUC did take the overlap into consideration

### CMS-1600-FC 238

and correctly accounted for it through a decrease in the preservice time from the specialty society survey

determined time of 13 minutes to 7 minutes. Theref ore, commenters requested that we accept the AMA RUC recommendation of a 0.93 work RVU with 7 minutes of preservice time and 5 minutes of postservice time. Response : Based on comments received, we re-reviewed CPT code 65222 and co ntinue to believe that our interim final work RVU of 0.84 is appropria te. We maintain that the AMA RUC did not fully account for the fact that some of the activities furnished during the preservice and postservice period of the procedure code overlap with those for the E/M visit, making the preservice time reductions recommended by the AMA RUC insufficient. As su ch, we continue to believe that 5 minutes of preservice evaluation time and 3 minutes of postservice time accurately reflect the physician time involved in furnishing the preservice and postservice work of this procedure, and that these times are well-aligned with similar services. Therefore, we are finalizing a work RVU of 0.84 to CPT code 65222 with 5 minutes of preservice evaluation time and 3 minutes of postservice, for CY 2014. (22) Eye and Ocular Adnexa: Ocular Adnexa (CPT code 67810) CPT code 67810 was identified as potentially mi svalued under the Harvard-valued utilization over 30,000 screen. On an interim final basis for CY 2013, we assigned the AMA RUC-recommended work RVU of 1.18 to CPT code 67810, with a refi nement to the AMA RUC-recommended time. As we noted in the CY 2013 final rule with comment period, Medicare claims data from CY 2011 indicated that CPT code 67810 was typically furnished to the benefici ary on the same day as an E/M visit. We noted that that some of the activities furnished during the preservice and postservice period of the procedure code and the E/M visit overlapped and that alt hough the AMA RUC appropriately accounted for this overlap in its recommendation of preservice time, its recommendation for postservice time was high relative to similar services performed on the same day as an E/M service. To better account for the overlap in the postservice period, and to value the service relative to similar services, we reduced the AMA RUC-recommended postservice time for this procedur e by one-third, from 5 minutes to 3 minutes.

### CMS-1600-FC 239

Comment : Commenters believed that our time refinement for CPT code 67810 was

unsubstantiated and that we were incorrect in assumi ng that the overlap between the E/M visit and the postservice period was not appropriately accounted fo r in the AMA RUC recommendation. Commenters suggested that the AMA RUC did take the overlap in to consideration and appropriately accounted for it by lowering the time recommendations by nearly 50 pe rcent. Therefore, commenters requested that we accept the AMA RUC-recommended postservice time of 5 minutes for CPT code 67810. Response : Based on comments received, we re-reviewed CPT code 67810 and co ntinue to believe

that our interim final work RVU of 1.18 and our time refinement is appropriate. We maintain that the AMA RUC did not fully account for the fact that so me of the activities furnished during the postservice period of the procedure code overlap with the E/M visit and that the AMA RUC’s time refinements were insufficient. As such, we continue to believe that 3 minutes of postservice time accurately reflects the physician time involved in furnishing the postservice wo rk of this procedure, and that this time is wellaligned with that for similar services. Therefore, we are finalizing a work RVU of 1.18 to CPT code 67810 with 3 minutes of postservice time for CY 2014. (23) Eye and Ocular Adnexa : Conjunctiva (CPT code 68200) CPT code 68200 was identified as potentially mi svalued under the Harvard-valued utilization over 30,000 screen. On an interim final basis for CY 2013, we assigned a work RVU of 0.49 to CPT code 68200, with a refinement to the AMA RUC-recommende d time. As we noted in the CY 2013 final rule with comment period, Medicare claims data from CY 2011 indicated that CPT code 68200 was typically furnished to the beneficiary on the same day as an E/ M visit. We believed that some of the activities furnished during the preservice and pos tservice period of the procedur e code overlapped with the E/M visit. We believed that the AMA RUC appropriately accounted for this overlap in its recommendation of preservice time, but did not adequately account for the overlap in the postservice time. To better account for the overlap in postservice time, we reduced the AMA RUC-recommended postservice time for this procedure by one-third, from 5 minutes to 3 minutes. After reviewing CPT code 68200 and assessing the overlap in time and work, we agreed with the AM A RUC-recommended work RVU of 0.49 for CY 2013.

### CMS-1600-FC 240

Comment : Commenters believed that our time refi nement for CPT code 68200 was unsupported and that we assumed incorrectly that the overlap be tween the E/M visit and the postservice period was not appropriately accounted for in the AMA RUC reco mmendation. Commenters suggested that the AMA RUC did take the overlap into consideration and completely accounted for it by lowering the preservice time recommendation. Therefore, commenters re quest that we accept the AMA RUC-recommended postservice time of 5 minutes postservice for CPT code 68200. Response : After reviewing the comments, we continue to believe that our refinement of the recommended time is appropriate. We maintain that the AMA RUC did not fully account for the fact that some of the activities furnished during the postservice period of the procedure code overlap with the E/M

visit and that the AMA RUC-recommended time refinement s were insufficient. As such, we continue to believe that 3 minutes of postservice time accurately reflects the time involved in furnishing the postservice work of this procedure, and that this tim e is well-aligned with similar services. Therefore, we are finalizing a work RVU of 0.49 for CPT code 68200 with 3 minutes of postservice time, for CY 2014. (24) Eye and Ocular Adnexa : Conjunctiva (CPT code 69200) CPT code 69200 was identified as potentially mi svalued under the Harvard-valued utilization over 30,000 screen. On an interim final basis fo r CY 2013, we assigned a work RVU of 0.77 to CPT code 69200, as well as refining to the AMA RUC- recommended time. In the CY 2013 final rule, we

noted that Medicare claims data from 2011 indicated th at CPT code 69200 was typically furnished to the beneficiary on the same day as an E/M visit and that some of the activities furnished during the preservice and postservice period of the procedur e code overlapped with the E/M vis it. To account for this overlap, we removed one-third of the preservice evaluation ti me from the preservice time package, reducing thepreservice evaluation time from 7 minutes to 5 minutes. Additionally, we reduced the AMA RUCrecommended postservice time for this procedure by one-third, from 5 minutes to 3 minutes. After reviewing CPT code 69200 and assessing the overlap in time and work, we agreed with the AMA RUCrecommended work RVU of 0.77 for CY 2013.

### CMS-1600-FC 241

Comment : A commenter thanked us for our acceptance of the AMA RUC-recommended work

for CPT code 69200. Response : For CY 2014, we are finalizing the interim final work RVU and time for this code. (25) Eye and Ocular Adnexa : Conjunctiva (CPT code 69433)

As detailed in the CY 2013 final rule with co mment period, we assigned an interim final work RVU of 1.57 to CPT code 69433; which the AMA RUC had recommended.

Comment : A commenter thanked us for our acceptance of the AMA RUC recommendation. Response : We are finalizing our interim final work RVU for CY 2014. (26) Computed Tomographic (CT) Angiography (CPT code 72191)

As detailed in the CY 2013 final rule with comment period, CPT code 72191 was assigned a CY 2013 interim final work RVU of 1.81, consistent with the AMA RUC recommendation.

As detailed in this final rule with comment period, based upon the AMA RUC recommendations, we are establishing interim final values for codes within the CT angiography family. To allow for contemporaneous public comment on this entire family of codes, we are maintaining the CY 2013 work

value for CPT code 72191 as interim final for CY 2014.

(27) Radiologic Guidance: Fluoroscopic Guidance (CPT codes 77001, 77002 and 77003)

As detailed in the CY 2013 final rule with comment period, CPT codes 77001, 77002 and 77003 were assigned CY 2013 interim fina l work RVUs of 0.38, 0.54 and 0.60, respectively, based upon AMA

RUC recommendations. We received AMA RUC recommenda tions for work RVUs of 0.38 for CPT code 77001, 0.54 for CPT code 77002 and 0.60 for CPT code 77003. We agree with the AMA RUC-recommended va lues but are concerned that the recommended intraservice times for all three codes are generally high er than the procedure codes with which they are typically billed. For example, CPT code 77002 h as 15 minutes of intraservice time and CPT code 20610 (Arthrocentesis, aspiration and/or injection; major joint or bursa (eg, shoulder, hip, knee joint, subacromial bursa)) has an intraservice time of onl y 5 minutes. We are requesting additional public comment and input from the AMA RUC and other stak eholders regarding the appropriate relationship

### CMS-1600-FC 242

between the intraservice time associated with fluor oscopic guidance and the intraservice time of the procedure codes with which they are typically billed. Therefore, for CY 2014 we are assigning CY 2014

interim final work RVUs of 0.38 to CPT code 770 01, 0.54 to CPT code 77002 and 0.60 to CPT code

77003. (28) Radiology (CPT codes 75896 and 75898) CPT code 75896 was identified as potentially mi svalued through the codes reported together 75 percent or more screen. As we noted in the CY 2013 final rule with comment period, the AMA RUC intended to survey and review CPT codes 75896 and 75898 for CY 2014 as part of their work on bundling thrombolysis codes. The AMA RUC recommended contractor pricing these two services for

CY 2014. However, since we had established a national payment rate for the professional component of these services and only the technical component of the services was contractor priced at that time, we maintained the national price on the professional com ponent and continued contractor pricing for the technical component for these codes on an interim final basis for CY 2013. We did not receive any comments on these cod es nor did we receive any recommendations from the AMA RUC. As we anticipate receiving AM A RUC recommendations for these codes, we are maintaining the current pricing on an interim final basis for CY 2014.

(29) Pathology (CPT codes 88120, 88121, 88365, 88367, and 88368)

The CPT Editorial Panel created CPT 88120 and 88121 effective for CY 2011. In the CY 2012 PFS final rule with comment period, we assigned interi m final work RVUs of 1.20 and 1.00 to CPT codes 88120 and 88121, respectively. We maintained th e 2012 work RVUs for 88120 and 88121 as interim final for CY 2013. Additionally, we expressed con cern about potential payment disparities between these codes and similar codes, CPT codes 88365, 88367 a nd 88368, and asked the AMA RUC to review the work and PE for these codes to ensure the appropriate relativity between the two sets of services. Since the AMA RUC is reviewing CPT codes 88365, 88367, and 88368, we are establishing CY 2014 interim final work RVUs of 1.20 for CPT code 88365, 1. 30 for CPT code 88367, and 1.40 for CPT code 88368

for CY 2014.

### CMS-1600-FC 243

Comment : A commenter stated that it was appropriate to reaffirm the values for 88120 and

88121. Response : For the reasons stated above, we are assign ing CY 2014 interim final work RVUs of 1.20 and 1.00 to CPT codes 88120 and 88121, respectively. (30) Optical Endomicroscopy (CPT Code 88375)

As detailed in the CY 2013 final rule with comment period, CPT code 88375 was assigned an interim final PFS procedure status of C (Contractor s price the code. Contractors establish RVUs and payment amounts for these services.). We receive d a recommendation from the AMA RUC for a work

RVU of 1.08 for CPT code 88375. CPT code 88375 provides a code for reporting th e pathology service when one is required to assist in the procedure. The AMA RUC recommended an intraservice time of 25 minutes and a work RVU of 1.08 for CPT code 88375. Based on our analys is of this recommendation, we believe that the typical optical endomicroscopy case will involve only the endoscopist, and CPT codes 43206 and 43253 are valued to reflect this. Accordingly, we belie ve a separate payment for CPT code 88375 would result in double payment for a portion of the overall optical endomicroscopy service. Therefore, we are assigning a PFS procedure status of I (Not valid for Medicare purposes. Medicare uses another code for the reporting of and the payment for these services) to CPT code 88375. In the unusual situation that a pathologist is requested to assist an endoscopist in optical endomicroscopy, we would expect the pathologist to report other codes more appropria te to the service (e.g. CPT code 88392 Pathology consultation during surgery).

(31) Psychiatry (CPT codes 90785, 90791, 90792, 90832, 90833, 90834, 90836, 90837, 90838, 90839, 90840, 90845, 90846, 90847, 90853 and 90863) For CY 2013, the CPT Editorial Panel restructured the psychiatry/psychotherapy CPT codes allowing for separate reporting of E/M codes, elimin ating the site-of-service differential, creating codes for crisis, and creating a series of add-on psychother apy codes to describe interactive complexity and medication management. The AMA RUC recommended valu es for all of the codes in this family except

### CMS-1600-FC 244

CPT codes 90785 (add-on for interactive complexity), 90839 (psychotherapy for crisis, first 60 minutes), 90840 (each additional 30 minutes) and 90863 (pha rmacologic management, when performed with psychotherapy) which were the AMA RUC recommended to be contractor priced. In establishing CY 2013 values for the psychitry codes, our general a pproach was to maintain the CY 2012 values for the services or adopt values that approximated the CY 201 2 values after adjusting for differences in code structure between CY 2012 and 2013, for all psychiatry /psychotherapy services on an interim final basis. We noted in the CY 2013 final rule with comment period that we intended to review the values for all the codes in the family once the survey process was comple te and we had recommendations for all the codes. This would allow for a comprehensive review of the values for the full code set that would ensure more accurate valuation and proper relativity. The CY 2013 in terim values for this family can be found in Table

24.

We have now received AMA RUC recommendations fo r all of the codes in the family and are establishing CY 2014 interim final work RVUs b ased on these recommendations. The CY 2014 interim work values displayed in Table 24 correspond with the AMA RUC recommended values, with the exception of CPT code 90863, which has been assign ed a PFS procedure status of I (Not valid for Medicare purposes. Medicare uses another code for the reporting of and the payment for these services). These recommendations, which are now complete, ha ve provided us with a comprehensive set of information regarding revisions to th e overall relative resource costs for these services. This is consistent with the approach we described in the CY 2013 PFS final rule with comment period (77 FR 69060 – 69063). Because of the changes for this relativity new code set, we are establishing these values on an

interim final basis.

Comment : Several commenters urged CMS to use the AMA RUC-recommended values for CY 2013 and questioned why CMS chose instead to adop t a general approach of maintaining the CY 2012

values for the services. These commenters noted that CMS has previously adopted interim final values for only a portion of new codes in a family, pending s ubsequent valuation of other codes in the family. Other commenters questioned the logic of maintaini ng preexisting values for these services since the new

### CMS-1600-FC 245

set of codes resulted from the identification of these services as potentially misvalued several years ago. Other commenters pointed out that the general appr oach to valuing the codes resulted in anomalous values. Several other commenters suggested altern ative work values for the codes with and without corresponding AMA RUC recommendations. Response : We appreciate commenters’ concerns rega rding the appropriate valuation of this family of codes. We also acknowledge that commenters accurately point out that, in some cases, we have previously established new interim values for new codes when related codes have not been simultaneously reviewed. However, as we explained in the CY 2013 final rule with comment period (77 FR 69060), the CY 2013 changes for this family of cod es consisted of a new structure that allowed for the separate reporting of E/M codes, the elimination of the site-of-service differential, the establishment of CPT codes for crisis, and the creation of a series of add-on CPT codes to psychotherapy to describe interactive complexity and medication management. We believed that the unusual complexity of these coding changes and the magnitude of their impact s among the affected specialties that furnish these services necessitated a comprehensive review of the potential impact of the changes prior to adopting significant changes in overall value. We also ac knowledge that maintaining overall value for services between calendar years with coding changes presents extensive challenges that often result in anomalous

values between individual codes. Since we are establi shing new interim final work RVUs for the codes in this family for CY 2014 based on the recommendations of the AMA RUC, we believe that commenters’ concerns regarding our approach to CY 2013 have been largely been mitigated for CY 2014. We note

that the interim final CY 2014 work RVUs for all of these services are open for comment and we will respond to comments regarding these values in the CY 2015 PFS final rule with comment period.

Comment : Several commenters stated that it was di fficult for health care professionals that furnish these services to implement use of the new CPT codes for Medicare payment with only a few months’ notice given the technology involved in claims systems. Other commenters suggested that CMS should revise CPT code descriptors for cod es to conform to Medicare policies.

### CMS-1600-FC 246

Response : We appreciate the concern regarding insuff icient time to adopt new codes. Although we would prefer for the new, revised and deleted codes to be released in time to appear in PFS proposed rulemaking, the timing of the annual release of the new codes set is completely under the control of the

CPT Editorial Panel. We note that CMS does not have the authority to alter CPT code descriptors.

Comment : Several commenters supported CMS’s decision to assign CPT code 90863 with a PFS procedure status indicator of I (Not valid for Me dicare purposes. Medicare uses another code for the reporting of and the payment for these services) for CY 2013 and encouraged CMS to maintain that status

for CY 2014. Response : We appreciate commenters’ support for this assignment. We understand from our past meetings with stakeholders that the ability to pr escribe medicine is predicated upon first providing evaluation and management (E/M) services. Although clinical psychologists have been granted prescriptive privileges in Louisiana and New Mexico, we do not believe that they are n authorized under their state scope of practice to furnish the full range of traditional E/M services. As a result, we believe that clinical psychologists continue to be precl uded from billing Medicare for pharmacologic management services under CPT code 90863 because pharmacologi c management services require some knowledge and ability to furnish E/M services, as some stake holders have indicated. Even though clinical psychologists in Louisiana and New Mexico have been granted prescriptive privileges, clinical psychologists overall remain unlicensed and unauthor ized by their state to furnish E/M services. Accordingly, on an interim final basis for CY 2014, for CPT code 90863, we are maintaining a PFS procedure status indicator of I (Not valid for Me dicare purposes. Medicare uses another code for the reporting of and the payment for these services.). (32) Cardiovascular: Therapeutic Services and Procedures (CPT codes 92920, 92921, 92924, 92925, 92928, and 92929) The CPT Editorial Panel created 13 new percutane ous coronary intervention (PCI) CPT codes for CY 2013 (92920, 92921, 92924, 92925, 92928, 92929, 92933, 92934, 92937, 92938, 92941, 92943, and 92944) to replace the 6 existing codes, which r esulted in a greater level of granularity.

### CMS-1600-FC 247

As detailed in the CY 2013 final rule with comme nt period, we believed that the CPT-established unbundling of the placement of branch-level stents may encourage increased placement of stents. To eliminate that incentive, on an in terim final basis for CY 2013, we rebundled the work associated with the placement of a stent in an arterial branch into the base code for the placement of a stent in an artery. Accordingly, for CY 2013 we bundled each new add-on code into its base code. Specifically, we bundled the work of CPT code 92921 into CPT code 92920, the work of CPT code 92925 into CPT code 92924, the work of CPT code 92929 into CPT code 92928, the work of CPT code 92934 into CPT code 92933, the work of CPT code 92938 into CPT code 92937; and the work of CPT code 92944 into CPT code

92943. In the CY 2013 final rule with comment period we explained how we established the work RVUs for the new bundled codes. For each code, we u sed the AMA RUC-recommended utilization crosswalk to determine what percentage of the base code utili zation would be billed with the add-on code, and added that percentage of the AMA RUC-recommended wo rk RVU for the add-on code to the AMA RUCrecommended work RVU for the base code. Based on this methodology, we assigned the following CY

2013 interim final work RVUs: 10.10 to CPT code 9 2920, 11.99 to CPT code 92924, 11.21 to CPT code 92928, 12.54 to CPT code 92933, 11.20 to CPT code 92937, and 12.56 to CPT code 92943. On an interim final basis for CY 2013, add-on CPT codes 92921, 92925, 92929, 92934, 92938, and 92944 were assigned a PFS procedure status indicat or of B (Bundled code. Payments for covered services are always bundled into payment for other services, which are not specified. If RVUs are shown, they are not used for Medicare payment. If these servi ces are covered, payment for them is subsumed by the payment for the services to which they are bundl ed.) Therefore, these codes were not separately payable.

As detailed in the CY 2013 final rule with comme nt period, we did not use this methodology to establish a work RVU for CPT code 92941, which di d not have a specific corresponding add-on code. After reviewing the service alongside the other services in the family, we belie ved CPT code 92941 had

the same work as CPT code 92943. As we stated a bove, we assigned a work RVU of 12.56 to CPT code

### CMS-1600-FC 248

92943. Therefore, on an interim final basis for CY 2013 we assigned a work RVU of 12.56 to CPT code

92941 with the AMA RUC-recommended intraservice time of 70 minutes.

Comment : Commenters disagreed with our bundling of codes into their respective base codes. Commenters stated that we negated the work of the CPT Editorial Panel, specialty societies, and the AMA RUC by further bundling already bundled codes for PCI services. They indicated that the additional bundling of payment for these codes gene rated a substantial disconnect between the coding guidelines detailed in the CPT manual and the use of th e codes under the Medicare system, causing great uncertainty and confusion. Additi onally, commenters stated that the decreases in PCI were of serious concern because it would drive physicians from priv ate practice. Therefore, commenters requested we adopt the CPT Editorial Panel coding construct and the AMA RUC-recommended values for all of the PCI codes. Furthermore, commenter s requested that we publish the va lues for the bundled codes, even though they were not recognized for separate payment by Medicare, so that third-party carriers who depend on the PFS to determine payment rates can de velop payment policies that conform to the CPT Editorial Panel’s coding decisions. Response : After re-review, we maintain that our va luation and bundling of codes into their respective base codes is appropriate. We continue to believe that the revised CPT coding structure represents a trend toward creating greater granularity in codes that describe the most intense and difficult work. Specifically for this code family, we conti nue to believe that making separate Medicare payment for unbundled codes that describe the placement of branch-level stents may encourage increased placement of stents in a fee-for-service system. To eliminate that incentiv e while maintaining an appropriate reflection of the resources involved in fu rnishing these services, we continue to believe that rebundling the work associated with the placement of a stent in an arteri al branch into the base code for the placement of a stent in an artery is appropria te and consistent with the prior coding structure. Therefore, we are finalizing work RVU values of 10.10 for CPT code 92920, 11.99 for CPT code 92924 and 11.21 for CPT 92928 and a PFS procedure stat us indicator of B (Bundled code. Payments for covered services are always bundled into payment for other services, which are not specified. If RVUs

### CMS-1600-FC 249

are shown, they are not used for Medicare payment. If these services are covered, payment for them is subsumed by the payment for the services to wh ich they are bundled for CPT codes 92921, 92925 and 92929 for CY 2014. We are also finalizing for CY 2014 a work RVU of 12.56 for CPT code 92941, with

the AMA RUC-recommended intraservice time of 70 minutes. (33) Cardiovascular: Intracardiac Electrophysiol ogical Procedures/Studies (C PT codes 93655 and 93657) Previously, CPT codes 93651 and 93652 were id entified as potentially misvalued through the codes reported together 75 percent or more screen. Upon reviewing these codes, the CPT Editorial Panel

deleted CPT codes 93651 and 93652 and and replaced them with ne w CPT codes 93653 through 93657 effective January 1, 2013.

As detailed in CY 2013 final rule with comment period, we believed these codes had a similar level of intensity to CPT codes 93653, 93654, and 9 3656, which were all valued at 5.00 RVUs per 1 hour of intraservice time. Therefore, for CY 2013 we assigned a work RVU of 7.50 to CPT codes 93655 and 93657, which have 90 minutes of intraservice time. The AMA RUC recommended a work RVU of 9.00

for CPT code 93655 and a work RVU of 10.00 for CPT code 93657.

Comment : Commenters disagreed with the incremen tal value methodology for CPT codes 93655 and 93657, stating that our approach did not accurate ly account for the intensity of these services. They

stated that CPT codes 93655 and 93657 are more in tense and complex procedures than CPT codes 93653, 93654, and 93656 because patients w ho require the services have widespread refractory disease, requiringadditional technical skill and time. Therefore, commenters requested we use the AMA RUCrecommended work RVUs of 9.0 for CPT code 93655 and 10.0 for CPT code 93657. In addition, one commenter requested that we refer these codes to the refinement panel. Response : After reviewing the request for refineme nt, we agreed that CPT codes 93655 and 93657 met the requirements for refinement and re ferred the codes to the CY 2013 multi-specialty refinement panel for further review. The refineme nt panel median work RVU for CPT codes 93655 and 93657 are 9.00, and 10.00 respectively. Following the re finement panel meeting, we again reviewed the

work involved in this code and c ontinue to believe that the two servi ces involve a very similar level of

### CMS-1600-FC 250

intensity to CPT codes 93653, 93654, and 93656, wh ich are all valued at 5.00 RVUs per 1 hour of

intraservice time. We continue to believe that th is is the appropriate va lue for CPT codes 93655 and

93657 because we believe these services contain the sam e amount of work as the base codes, CPT codes 93653, 93654, and 93656. Therefore, we are fina lizing a work RVU of 7.50 for CPT codes 93655 and

93657 for CY 2014. (34) Noninvasive Vascular Diagnostic Studies: Extremity Arterial Studies (Including Digits) (CPT codes 93925 and 93926) Previously, CPT codes 93925 and 93926 were identified by the AMA RUC as potentially

misvalued and we received AMA RUC recommendations for CY 2013. After reviewing CPT codes 93925 and 9392 6, we believed that the survey’s 25 th percentile work RVUs of 0.80 for CPT code 93925 and 0.50 for CPT code 93926 accurately accounted for the work involved in furnishing the services and appropriately captured the increase in work since the services were last valued and assigned these as interim final wo rk RVUs for CY 2013. As we noted in the CY 2013 final rule with comment period, we believed that the AMA RUC-recommende d survey median work

RVUs of 0.90 for CPT code 93925 and 0.70 for CPT code 93926 overstated the increase in work for the services and that the RVUs were too high relative to similar services. Regarding physician time, we refined the AMA RUC-recommended preservice and postservice times from 5 minutes to 3 minutes to align with similar services, specifically CPT codes 93922 and 93923.

Comment : All commenters disagreed with our wo rk valuation and some commenters also disagreed with our time refinements for CPT codes 93925 and 93926. One commenter stated that the

work RVUs for CPT codes 93925 a nd 93926 should be increased because the work associated with the services has changed and also argued that our valuatio ns were arbitrary in na ture and unsupported. Two

commenters noted that the AMA RUC-recommended work RVUs of 0.90 for CPT code 93925 and 0.70 for CPT code 93926 were supported by relativity co mparisons to CPT codes 93306, 73700, 76776 and 76817 and according the CY 2013 interim final work RVU values were too low. Additionally, two commenters disagreed with our time refinements for CPT codes 93925 and 93926 from the survey’s

### CMS-1600-FC 251

median to the survey’s 25 th percentile values. One commenter specif ically disagreed with our use of CPT

codes 93922 and 93923 as reference codes for time refi nements because they stated “physiologic studies do not require artery-by-artery inch-by-inch assessm ent of femoral and tibial arteries, as do the duplex exams” and as such, are not appropriate codes for comparison. They added that CPT codes 93925 and 93926 require more time for proper performance of the exam and interpretation of results. All commenters suggested acceptance of the AMA RUC recommendations. One commenter also requested refinement panel review of the codes. Response : After evaluation of the request for refineme nt, we determined that the criteria for the request for refinement were not met and, as a result, we did not refer CPT codes 93925 and 93926 to the CY 2013 multi-specialty refinement panel for further review. After reviewing the comments, we maintain that our valuation is appropria te. We continue to believe that that the survey’s 25 th percentile work RVUs of 0.80 fo r CPT code 93925, and 0.50 for CPT code 93926 accurately account for the work involved in furnishing these services and appropriately captures the increase in work since these services were last valued. Additionally, we c ontinue to believe

that a refinement to the AMA RUC-recommended time is appropriate to align the times with those

associated with CPT codes 93922 and 93923 that describ e similar services. Therefore, we are finalizing a

work RVU of 0.80 to CPT code 93925 and a work RVU of 0.50 to CPT code 93926, with 3 minutes of preservice and postservice time for CY 2014. (35) Neurology and Neuromuscular Procedures: Sl eep Medicine Testing CPT codes 95782 and 95783)

The CPT Editorial Panel created new CPT codes 9578 2 and 95783, effective January 1, 2013, to describe the work involved in pediatric polysomnography for children 5 years of age or younger. For CY 2013, we assigned an interim final work RVU of 2.60 to CPT code 95782 and a work RVU of 2.83 to

CPT code 95783. As we noted in the CY 2013 final rule with comment period, we assigned these values

after we reviewed CPT codes 95782 and 95783 and determined that the survey’s 25 th percentile work

RVUs of 2.60 for CPT code 95782 and 2.83 for CP T code 95783 appropriately reflected the work

### CMS-1600-FC 252

involved in furnishing the services. The AMA RUC recommended the survey’s median work RVUs of

3.00 for CPT code 95782 and 3.20 for CPT code 95783.

Comment : Commenters disagreed with our valuation of CPT codes 95782 and 95783, stating that the services should have received a greater valuation expl aining that it is more difficult to perform sleep studies on children than adults, and more work is required to obtain an accurate polysomnogram due to children’s greater need for attention and, in some ca ses, even mild sedation. Additionally, commenters noted that the work involved in the interpretation of data supported a higher work RVU. Therefore, commenters requested that we use the AMA RUC- recommended work RVU of 3.00 for CPT code 95782

and 3.20 for CPT code 95783. Response : After consideration of comments and re-re viewing of CPT codes 95782 and 95783, we

maintain that our valuation is appropriate. We continue to belie ve that that the survey’s 25 th percentile

work RVUs of 2.60 for CPT code 95782 and 2.83 for CPT code 95 783 accurately accounts for the work involved in furnishing these services. Therefore, we are finalizing a work RVU of 2.60 for CPT code 95782 and 2.83 for CPT code 95783, for CY 2014. (36) Neurology and Neuromuscular Procedures: Electromyography and Nerve Conduction Tests (CPT codes 95885, 95886, and 95887) CPT codes 95860, 95861, 95863, and 95864 were previously identified as potentially misvalued through the codes reported together 75 percent or more screen. The relevant specialty societies submitted a code change proposal to the CPT Editorial Panel to bundle the services commonly reported together. In response, the CPT created three add-on codes (CPT codes 95885, 95886, and 95887) and seven new codes (CPT codes 95907 through 95913) that bundled the work of mu ltiple nerve conduction studies into

each individual code. We agreed with the AMA RUC recommendati on for CPT code 95885 and assigned a CY 2013 interim final work RVU of 0.35. After review, we determined that CPT codes 95886 and 95887 involved the same level of work intensity as CPT code 95885. To determine the appropriate RVU for CPT codes 95886 and 95887, we increased the work RVUs of CPT codes 95886 and 9588 7 proportionate to the

### CMS-1600-FC 253

differences in times from CPT code 95885. Therefore, we assigned an interim final work RVU of 0.70 toCPT code 95886 and of 0.47 to CPT code 95887 for CY 2013 as compared to the AMA RUCrecommended 0.92 and 0.73, respectively.

Comment : Commenters indicated that we utilized a fl awed building block approach in valuing CPT codes 95886 and 95887 because the methodology di d not take into account precise distinctions within each service and inaccurately assumed that th e codes had identical intensity and complexity. Commenters supported the AMA RUC-recommended va lues developed using magnitude estimation saying that the methodology was more precise due to its use of data derived from multiple factors like physician time, intensity and work value estimates. Additionally, commenters noted that we failed to distinguish the increasing intensity and complex ity involved as additional nerve conductions were performed. Therefore, commenters requested our use of the AMA RUC-recommended work RVU of

0.92 for CPT code 95886 and 0.73 for CPT code 95887 and refinement panel review of the codes. Response : After reviewing the request for refinement, we agreed that CPT codes 95886 and 95887 met the requirements for refinement and re ferred the codes to the CY 2013 multi-specialty refinement panel for further review. The refinement panel median work RVUs for CPT codes 95886 and 95887 were respectively, 0.92 and 0.73. Following the refinement panel meeting, we again reviewed the work involved in these codes and agreed with the pa nel that these codes were more intense and complex

than reflected in the CY 2013 interim final values a nd, as such, warranted a higher work RVU. While we agree that work RVUs for CPT codes 95886 and 95887 should be increased, based on our clinical review, we conclude that the refinement panel’s sugg ested values overstate the work involved in these procedures.

We believe that the work for CPT code 95886 is si milar to the work performed when five or more muscles are examined in one extremity, as described by CPT code 95860, which has a work RVU of 0.96. However, CPT code 95886 is an add-on code to nerve conduction st udies. Therefore, as we have previously valued services that overlap with anothe r CPT code, we applied a 10% reduction to the work

RVU of CPT code 95860 to determine a work RVU of 0.86 for CPT code 95886. Similarly, in our

### CMS-1600-FC 254

valuation of CPT code 95887, we believe that the wo rk for the code is similar to the work performed when cranial nerve supplied muscles are examined, as described by CPT code 95867, which has a work RVU of 0.79. However, CPT code 95887 is an a dd-on code to nerve conduction studies. Therefore, as we have previously valued services that overlap with another code, we applied a 10 percent reduction to

the work RVU of CPT code 95867 to determine a wo rk RVU of 0.79 for CPT code 95887. For CY 2014, we are finalizing a work RVU of 0.86 for C PT code 95886 and 0.71 for CPT code 95887. (37) Neurology and Neuromuscular Procedures: Electromyography and Nerve Conduction Tests (CPT codes 95908, 95909, 95910, 95911, 95912, and 95913) In our CY 2013 review, we did not accept the AMA RUC-recommended values for CPT codes 95908, 95909, 95910, 95911, 95912, and 95913. For those codes, we found that the progression of the survey’s 25 th percentile work RVUs and survey’s median tim es appropriately reflected the relativity of the services and valued the codes accordingly. CPT code 95908 was an exception to this, as we believed the survey’s 25 th percentile work RVU was too low relative to other fee schedule services. Therefore, we assigned the following work RVUs for CY 2013: 1.00 to CPT code 95907, 1.25 to CPT code 95908, 1.50 to CPT code 95909, 2.00 to CPT code 95910, 2.50 to CPT code 95911, 3.00 to CPT code 95912, and 3.56

to CPT code 95913. Additionally, we refined the AMA RUC-reco mmended intraservice time for CPT code 95908 from 25 minutes to the survey’s median time of 22 minutes and for CPT code 95909 from 35 minutes to the survey’s median time of 30 minutes, so that a ll the CPT codes in the series were valued using the survey’s median intraservice time.

Comment : Commenters disagreed with our valuation of CPT codes 95908, 95909, 95910, 95911, 95912, and 95913. Commenters opposed the interim fi nal values for the codes because they believed the intensity and complexity of the procedures increased as more nerve conductions were performed and as a result, believed that the valuations should be hi gher. Additionally, commenters believe that because no significant changes in the efficiencies of the test ha d occurred, in terms of time and cost related to performance, that our changes in th e valuations were unjustified. Therefore, commenters requested that

### CMS-1600-FC 255

we accept the AMA RUC-recommended work RVUs fo r all of these codes and requested refinement panel review. Lastly, commenters also suggested that if the interim final values were to be finalized, that their implementation be staggered to limit the adverse impacts that the values would have on health care

access. Response : After reviewing the request for refinement, we agreed that CPT codes 95908, 95909, 95910, 95911, 95912, and 95913 met the requirements fo r refinement and referred the codes to the CY 2013 multi-specialty refinement panel for further revi ew. The refinement panel median work RVUs were: 1.37 for CPT code 95908, 1.77 for CPT code 95909, 2.80 for CPT code 95910, 3.34 for CPT code 95911, 4.00 for CPT code 95912, and 4.20 for CPT code 95913 . Following the refinement panel meeting, we again reviewed the work involved in these codes a nd continue to believe that the progression of the survey’s 25th percentile work RVUs and survey me dian times for these codes appropriately reflect the relativity of these codes. CPT code 95908 was an exce ption to this approach because we believe that the survey’s 25 th percentile work RVU is too low relative to ot her fee schedule services. We also note that we do not believe that the results of the survey suppor t the notion that the intensity and complexity of the procedures increases as more nerve conductions are perfo rmed. Instead, we believe that the incremental differences reflected in the survey correspond with the incremental differences in our CY 2013 interim final values. Therefore, we are finalizing the CY 2013 interim final work RVUs and time refinements for CPT codes 95908, 95909, 95910, 95911, 95912, and 95913 for CY 2014. With regard to the comment that our rates would impede access to these critical services, we are unaware of data that shows that

access has declined. (38) Evoked Potentials (CPT codes 95928 and 95929)

As detailed in the CY 2013 final rule with comment period, CPT cod es 95928 and 95929 were each assigned a CY 2013 interim final work RVU of 1.50. Subsequently, the AMA RUC recommended intraservice time for these codes based on only 19 of th e 28 survey responses. As a result, the AMA RUC

recommendations included an intraservice time of 40 minutes with which we do not agree. When based on all 28 survey responses, the intraservice time is 33 minutes. We agree with the AMA RUC

### CMS-1600-FC 256

recommended preservice and postservice times because they are consistent across all 28 survey responses. Therefore, for CY 2014, we are refining the preservice time, intraservice and postservice times for CPT codes 95928 and 95929 to 15 minutes, 33 minutes and 10 minutes, respectively. We are assigning CY

2014 interim final work RVUs of 1.50 to C PT codes 95928 and 95929, based upon the AMA RUC recommendations, and are seeking public input on the time of the codes. (39) Neurology and Neuromuscular Procedures: In traoperative Neurophysiology (CPT codes 95940 and 95941 and HCPCS code G0453) Effective January 1, 2013, the CPT Editorial Pa nel deleted CPT code 95920 and replaced it with CPT codes 95940 for continuous intraoperative neur ophysiology monitoring in the operating room requiring personal attendance and 9594 1 for continuous intraoperative neurophysiology monitoring from outside the operating room (remote or nearby). Prior to CY 2013, the Medicare PFS paid for remote monitoring billed under CPT code 95920, which was used for both in-person and remote monitoring. For CY 2013, we created HCPCS code G0453 to be used for Medicare purposes instead of CPT code 95941. Unlike CPT code 95941, HCPCS code G0453 can be billed only for undivided attention by the monitoring physician to a single beneficiary, not for the monitoring of multiple beneficiaries simultaneously. Since G0453 was used for remote mo nitoring of Medicare beneficiaries, CPT code 95941 was assigned a PFS procedure status indicator of I (Not valid for Medicare purposes. Medicare uses another code for the reporting of and the payment for these services.

As detailed in the CY 2013 final rule with comme nt period, after reviewing CPT code 95940, we agreed with the AMA RUC that a work RVU of 0. 60 accurately accounted for the work involved in furnishing the procedure. Also, we agreed with the AMA RUC that a work RVU of 2.00 accurately accounted for the work involved in furnishing 60 minutes of continuous intraoperative neurophysiology monitoring from outside the operating room. Accord ingly, we assigned a work RVU of 0.50 to HCPCS code G0453, which described 15 minutes of monitori ng from outside the operating room, on an interim

final basis for CY 2013.

### CMS-1600-FC 257

Comment : Commenters disagreed with our valuation of CPT codes 95940, 95941 and G0453. Commenters opposed the one-on-one patient to physician model that our recommendations proposed. Commenters stated the following: G0453 was contradi ctory to current provider models; the accessibility of IONM services would be lowered; surgeons woul d be deprived of advantageous services; qualified level of professional supervision would be reduced; hospitals would suffer increased overheard costs; and GO453 inappropriately assessed the services. Theref ore, commenters requested we withdraw HCPCS

code G0453 and validate CPT cod es 95940 and 95941 together, through acceptance of the AMA RUCrecommended work RVUs of 0.60 for CPT c ode 95940 and 2.00 for CPT code 95941. Another commenter suggested we value CPT code 95941 at 0.5 of CPT 95940 although a rationale for that valuation was not provided. Seve ral other commenters requested we increase the work value of G0453 so that it was equal to the work RVU assigned to CPT code 95940 because they believed the physician time and effort for both services was the same. The majority of commenters suggested we value the concurrent monitoring of up to 4 patients by a neurologist with the creation of additional G codes for the remote monitoring of 2, 3 or 4 patients. Response : Based on comments received, we re-revi ewed CPT codes 95940, 95941 and HCPCS code G0453 and agree that based on the comparable nature of the work between CPT code 95940 and HCPCS code G0453, that G0453 should be valued equally to CPT code 95940. Therefore, we are finalizing a work RVU of 0. 60 to CPT code 95940 and 0.60 to HCPCS code G0453 for CY 2014. We are also finalizing a PFS proce dure status indicator of I (Not valid for Medicare purposes. Medicare uses another code for the repor ting of and the payment for these services) to CPT code 95941 for CY 2014,.because for Medicare purposes, HCPCS code G0453 will continue to be used instead of CPT code 95941. Although we consider ed commenters’ suggestions to value concurrent monitoring of up to 3 or 4 patients by a neurologist w ith the creation of additional G-codes for the remote monitoring of 2, 3 or 4 patients, creation of these G codes would allow billing for more than 60 minutes of work during a 60 minute time period. We conti nue to believe that HCPC S code G0453 adequately accounts for the relative resources involved when the ph ysician monitors a Medicare beneficiary, while it

### CMS-1600-FC 258

precludes inaccurate payment in cases where multiple patients are being monitored simultaneously. Therefore, we will maintain the current c ode descriptor for HCPCS code G0453.

Comment : Some commenters suggested we create me chanisms for practitioners to report the professional and technical components separately for CPT codes 95940 and HCPCS code G0453. One of these commenters suggested that creat ing separate technical component payment for the PFS would allow hospitals to approximate the relative resource costs associated with the technical component of the

service. Response : It is our understanding that these services are nearly always furnished to beneficiaries in facility settings. Therefore, Medicare would not make payments through the PFS that account for the clinical labor, disposable supplies, or medical equipment involved in furnishing the service. Instead, these resource costs would be included in the paym ent Medicare makes to the facility through other payment mechanisms. Therefore, we do not believe it would be appropriate to create separate payment rates for the professional and technical component of these services. (40) Neurology System: Autonomic Function Tests (CPT code 95943)

As detailed in the CY 2013 final rule with co mment period, we assigned a PFS procedure status of C to CPT code 95943, pursuant to the AMA RU C recommendation. (Contractors price the code. Contractors establish RVUs and payment amounts for these services.) The AMA RUC believes that a PFS procedure status of “C” was appropriate because they did not have sufficient information for making a specific work RVU recommendation.

Comment : Commenters opposed contractor pricing of CPT code 95943 because the other autonomic nervous system testing codes have na tional work RVUs and payment rates. Commenters suggested we crosswalk CPT code 95943 to CPT code 95924 due to the procedures’ similarity in total

work. Response : We continue to believe that a PFS procedur e status of C (Contractors price the code. Contractors establish RVUs and payment amounts for th ese services.) is appropriate for CPT code 95943.

### CMS-1600-FC 259

We do not believe that the commenters provided suffici ent data to value the service. Therefore, we are finalizing a Contractor Pricing procedure status to CPT code 95943 for CY 2014. (41) Inpatient Neonatal Intensive Care Services a nd Pediatric and Neonatal Critical Care Services:

Pediatric Critical Care Patient Transport (CPT codes 99485 and 99486) For CY 2013, he CPT editorial panel create d CPT codes 99485 and 99486, to describe the nonface-to-face services provided by physician to superv ise interfacility care of critically ill or critically injured pediatric patients.

As detailed in the CY 2013 final rule with co mment period, we reviewed CPT codes 99485 and

99486 and believed the services should be bundled into other services and not be separately payable. We

believed the services were similar to CPT code 99288 , which is also bundled on the PFS. The AMA

RUC recommended a work RVU of 1.50 for CPT code 99485 and a work RVU of 1.30 for CPT code 99486. On an interim final basis for CY 2013, we assigned CPT codes 99485 and 99486 a PFS procedure status indicator of B (Payments for covered services are always bundled into payment for other services, which are not specified. If RVUs are shown, they ar e not used for Medicare payment. If these services are covered, payment for them is subsumed by the payment for the services to which they are bundled).

Comment : Commenters disagreed with our assignment of CPT codes 99485 and 99486 as bundled codes. They stated that that classification puts pediatric physicians at a disadvantage since the majority of non-Medicare payers will commonl y bundle the codes as well. Commenters strongly recommended that we adopt status indicator A (Active) or, at the very least, status indicator N (Noncovered Service) for CPT codes 99485 and 99486. Response : We continue to believe that CPT cod es 99485 and 99486 are similar to CPT code 99288 and, like CPT code 99288, involve work that is already considered in the valuation of other services. Therefore, we do not believe that these services should be separately payable. Therefore, we are finalizing a PFS procedure status of B (Payments for covered services are always bundled into payment for other services, which are not specified. If RVUs are shown, they are not used for Medicare

### CMS-1600-FC 260

payment. If these services are covered, payment for th em is subsumed by the payment for the services to which they are bundled) to CPT codes 99485 and 99486 for CY 2014. (42) Molecular Pathology (HCPCS code G0452)

As detailed in the CY 2013 final rule with comme nt period, one of the molecular pathology CPT codes that was deleted by CPT for CY 2012 was pa yable on the PFS: CPT code 83912-26. To replace this CPT code, we created HCPCS code G0452 to describe medically necessary interpretation and written report of a molecular pathology test, above and beyond the report of laboratory results. We reviewed the work associated with this procedure and we believed it was appropriate to directly crosswalk the work

RVUs and times of CPT code 83912-26 to HCPCS c ode G0452, because we did not believe the coding change reflected a change in the service or in the resources involved in furnishing the service. Accordingly, we assigned a work RVU of 0.37, with 5 minutes of preservice time, 10 minutes of intraservice time, and 5 minutes of postservice time to HCPCS code G0452 on an interim final basis for

CY 2013.

Comment : Commenters disagreed with our valua tion of HCPCS code G0452. Commenters expressed concern about the creation of a single HC PCS G-code to distinguish work related to a considerable number of procedures with changi ng relative values recommended by the AMA RUC. Response : The decision to pay for molecular pa thology codes under the CLFS required the creation of a new code for the interpretation a nd reporting services by pathologists on the PFS. We

continue to believe that the creation of HCPCS code G0452 was appropriate to describe medically necessary interpretation and written report of a molecula r pathology test, above and beyond the report of laboratory results. We also believe that this single HC PCS code is sufficient to capture the work involved in any of the numerous molecular pathology cod es. Additionally, the professional component-only HCPCS G-code is a “clinical laboratory interpretation service,” which is one of the current categories of PFS pathology services under the definition of physicia n pathology services at §415.130(b)(4). Therefore, we are finalizing a work RVU of 0.37 to HCPCS code G0452. (43) Digestive System: Intestines (Except Rectum) (CPT code G0455)

### CMS-1600-FC 261

For CY 2013, we created HCPCS code G0455 to be used for Medicare purposes instead

of CPT code 44705. HCPCS code G0455 will be used to bundle the preparation and instillation of microbiota. CPT code 44705 was assigned a PFS pr ocedure status indicator of I (Not valid for Medicare purposes). After reviewing the preparation and instillation work associated with this procedure, we believed that CPT code 99213 was an appropriate crosswalk for the work and time of HCPCS code G0455. Therefore, on an interim final basi s for CY 2013, we assigned a work RVU of 0.97

to HCPCS code G0455.

Comment : Commenters disagreed with our valuation of HCPCS code G0455. Commenters opposed the interim final work RVU because they believed extensive work was required for the preparation of the microbiota, to determine if a patient was an appropriate

candidate for fecal donation. Commenters believ ed that our work RVU valuation failed to distinguish between varying clinical circumstance s for the use of this code. Commenters also suggested that we should consid er coverage of more than on e donor specimen screening when clinically suitable. Response : After review, we agree with the commenters that the interim final work RVU

of 0.97 undervalues this service. We believe that bundling the work RVU and physician time of CPT code 80500, a lab pathology consultation, with CPT code 99213 more appropriately values this work. Therefore, we are finalizing a work RVU of 1.34 and an intraservice time of 28

minutes for HCPCS code G0455. b. Finalizing CY 2013 Inte rim Direct PE Inputs (i) Background and Methodology

### CMS-1600-FC 262

On an annual basis, the AMA RUC provide s CMS with recommendations regarding direct PE inputs, including clini cal labor, disposable supplies, a nd medical equipment, for new, revised, and potentially misvalued codes. We review the AMA RUC-recommended direct PE inputs on a code-by-code basis. When we determine that the AMA RUC recommendations appropriately estimate the direct PE inputs requ ired for the typical se rvice and reflect our payment policies, we use those direct PE inputs to value a service. If not, we refine the PE inputs to better reflect our estima te of the PE resources required for the service. We also confirm whether CPT codes should have facility and/or nonf acility direct PE inputs and refine the inputs accordingly.

In the CY 2013 PFS final rule with comment period (77 FR 69072), we addressed the general nature of some of our common refine ments to the AMA RUC-recommended direct PE inputs as well as the reasons for refinements to pa rticular inputs. In the following subsections, we respond to the comments we received rega rding common refinements we made based on established principles or policies. Following those discussions, we summarize and respond to comments received regarding other refi nements to particular codes.

We note that the interim final direct PE i nputs for CY 2013 that are being finalized for CY 2014 are displayed in the final CY 2014 dire ct PE input database, available on the CMS

website under the downloads for the CY 2014 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-fo r-Service-Payment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html . The inputs displayed there have also been used in developing the CY 2014 PE RVUs as displayed in Addendum B of this final rule with comment period. (ii) Common Refinements (1) Equipment Time

### CMS-1600-FC 263

Prior to CY 2010, the AMA RUC did not gene rally provide CMS with recommendations regarding equipment time inputs. In CY 2010, in the interest of ensuring the greatest possible degree of accuracy in allocati ng equipment minutes, we request ed that the AMA RUC provide equipment times along with the other direct PE recommendations, and we provided the AMA RUC with general guidelines rega rding appropriate equipment time inputs. We continue to appreciate the AMA RUC’s willingness to provide us with these additional inputs as part of its

direct PE recommendations. In general, the equipment time inputs corres pond to the service period portion of the clinical labor times. We have clarified this prin ciple, indicating that we consider equipment time as the times within the intraservice period when a clinician is using the pi ece of equipment plus any additional time that the piece of equipment is not available for use for another patient due to its use during the designated pr ocedure. For services in whic h we allocate cleaning time to portable equipment items, we do not include that time for the remaining equipment items as they are available for use for other patients during that time. In addition, when a piece of equipment is typically used during any addi tional visits included in a serv ice’s global period, the equipment

time would also reflect that use. We believe that certain highly technical pi eces of equipment and equipment rooms are less likely to be used during all of the preservi ce or postservice tasks performed by clinical labor staff on the day of the procedure (t he clinical labor serv ice period) and are typically available for other patients even when one member of clinical staff may be occupied with a preservice or postservice task related to the procedure. Some commenters have repeatedly objected to our rationale for refinement of equipment minutes on this basis. We acknowledge the comme nts we received that re iterate those objections

### CMS-1600-FC 264

to this rationale and refer readers to our exte nsive discussion regarding those objections in the CY 2012 PFS final rule with comment period (76 FR 73182). In the following paragraphs we address new comments on this policy.

Comment : Several commenters pointed out that technician time is independent of physician time for some procedures so that equipment time should not be altered based on changes in physician intraservice time. Response : The estimated time it takes for a practitioner or clinical staff to furnish a procedure is an important factor used in determining the appropriat e direct PE input values used in developing nonfacility PE RVUs. For many servi ces, the physician intraservice time serves as the basis for allocating the appropriate number of minutes within the service period to account for the time used in furnishing the service to the patient. In the case of many services, the number of physician intraservice minutes, or oc casionally a particular proportion thereof, is

allocated to both the clinical staff that assist th e practitioner in furnishi ng the service and to the equipment used by either the prac titioner or the staff in furnishing the service. This allocation reflects only the time the beneficiary receives treatment and does not include resources used immediately prior to or following the service. Additional minutes are often allocated to both clinical labor and equipment resources to acco unt for the time used for necessary preparatory tasks immediately preceding the procedure or tasks typically performe d immediately following it. For these services, we routinely adjust the mi nutes assigned to the direct PE inputs so that they correspond with the procedure time assumptions displayed in the physician time file that are used in determining work RVUs and allocating indirect PE values. The commenters accurately point out that for a significant number of services, especially diagnostic tests, the procedure time assumpti ons used in determining direct PE inputs are

### CMS-1600-FC 265

distinct from, and therefore not dependent on, physician intraservice time assumptions. For these services, we do not make refinements to the di rect PE inputs based on changes to estimated physician intraservice times.

Comment : Several commenters asked that CMS identify what constitutes a highly technical piece of equipment. Response : During our review of all recommended direct PE inputs, we consider whether or not particular equipment items would typically be used in the most efficient manner possible. In making this determination, we consider such items as the degree of specificity of a piece of equipment, which may influence whether the equipm ent item is likely to be stored in the same room in which the clinical staff greets and gow ns, obtains vitals, or provides education to a patient prior to the procedure itself. We also co nsider the level of portability (including the level of difficulty involved in cleani ng the equipment item) to determine whether an item could be easily transferred between rooms before or after a given procedure. We also examine the prices for the particular equipment items to determine wh ether the equipment is likely to be located in the same room used for all the tasks undertaken by clinical staff prior to and following the procedure. For each service, on a case-by-case basi s, we look at the description provided in the

AMA RUC recommendation and consider the ov erlap of the equipment item’s level of specificity, portability, a nd cost; and, consistent with the revi ew of other recommended direct PE inputs, make the determination of whether the recommended equipment items are highly

technical. (2) Standard Tasks and Minutes for Clinical Labor Tasks In general, the preservice, service peri od, and postservice clin ical labor minutes associated with clinical labor inpu ts in the direct PE input databa se reflect the sum of particular

### CMS-1600-FC 266

tasks described in the information that accompanies the recommended direct PE inputs, “PE worksheets.” For most of these described tasks, there are a standardized number of minutes, depending on the type of procedure, its typical se tting, its global period, an d the other procedures with which it is typically reported. At times , the AMA RUC recommends a number of minutes either greater than or less than the time typica lly allotted for certain tasks. In those cases, CMS

clinical staff reviews the de viations from the standards to determine their clinical appropriateness. Where the AMA RUC-recomme nded exceptions are not accepted, we refine the interim final direct PE inputs to match the sta ndard times for those tasks. In addition, in cases when a service is typically billed with an E/M, we remove the pr eservice clinical labor tasks so that the inputs are not duplicative and reflect the resource costs of furnishing the typical service. In general, clinical labor tasks fall into one of the categories on the PE worksheets. In

cases where tasks cannot be attributed to an existing category, the tasks are labeled “other clinical activity.” In these instances, CMS clinic al staff reviews these tasks to determine whether they are similar to tasks delineated for other se rvices under the PFS. For those tasks that do not meet this criterion, we do not accept those clinical labor tasks as direct inputs.

Comment : Several commenters objected to CMS’ s refinement to recommended clinical

labor minutes to meet these standards in cas es where the recommendation included information suggesting that the service requires specialized clin ical labor tasks, especi ally relating to quality assurance documentation, that are not typically included on the PE worksheets. Response : Although we appreciate the importance of quality assurance and other tasks, we note that the nonfacility direct PE inputs in clude an estimated number of clinical labor minutes for most codes developed based on an extensiv e, standard list of c linical labor tasks such as “prepare equipment,” and “prepare and positio n patient.” We believe that quality assurance

### CMS-1600-FC 267

documentation tasks for services across the PFS ar e already accounted for in the overall estimate

of clinical labor time. We do not believe that it would serve the relativity of the direct PE input

database were additional minutes added for each clin ical task that could be discretely described for every code and thus are no t making any changes based upon this comment. (3) Equipment Minutes for Film Equipment Inputs In general, the equipment time allocated to film equipment, such as “film processor, dry, laser” (ED024), “film processor, wet” (ED025), and “film alternator (motorized film viewbox)” (ER029), corresponds to the clinical labor task “hang and process film.”

Comment : Several commenters argued that the film equipment should be allocated for the entire service period. Response : We believe that the film equipment, when used, is typically only used during the time associated with certain clinical labor tasks, and is otherwise generally available for use in furnishing services to other patients. In reviewing these equipm ent inputs in the direct PE input database, we note that this equipment is generally not allocated for the full number of minutes of the clinical labor service period. Because we do not believe that this equipmen t would be in use during periods other than during particular clinical labor tasks, and to maintain re lativity, we are finalizing the CY 2013 direct PE inputs based on this general principle. (4) Film Inputs as a Proxy for Digital Imaging Inputs

Comment : A few commenters objected to our refinement of certain film inputs including eliminating VHS video system and tapes, and reduc ing the number of films for several procedures. Commenters also stated that the film processor was a necessary input for several procedures from which it

was removed. Response : As stated in the CY 2013 PFS final rule with comment period (77 FR 69029), a variety of imaging services across the PFS include di rect PE inputs that reflect film-based technology instead of digital technology. We believe that for imaging services, digital technology is more typical

### CMS-1600-FC 268

than film technology. However, stakeholders, including the AMA RUC, have recommended that we continue to use film technology inputs as a proxy fo r digital until digital inputs for all imaging services can be considered. In response to these recommenda tions, we have maintained inputs for film-based technology as proxy inputs while this review occu rs. In the case of new, revised, and potentially misvalued codes, we have accepted the recommended pr oxy inputs to the extent that the recommended proxy inputs are those that are usually associated w ith imaging codes. However, we have not accepted recommended inputs that are not usually included in other imaging services. We have reviewed the recommended inclusion of the film processor and, upon additional review, noted th at the item is routinely included in other imaging codes. Therefore, we are including that item in the direct PE input database. We anticipate updating all of the associated inputs in fu ture rulemaking. After consideration of comments received, we are finalizing the direct PE inputs in accordance with this general principle with the additional refinement of inserting the film processor for relevant codes. (iii) Code-Specific Direct PE Inputs We note that we received many comments objec ting to refinements made based on CMS clinical review (including our determination that certain r ecommended items were duplicative of others already included with the service), statutory requirements, or established principles and policies under the PFS. We note that for many of our refinements, the medi cal specialty societies that represent the practitioners who furnish the service objected to most of these refi nements for the general reasons described above or for the reasons we respond to in the “background and methodology” portion of this section. Below, we respond to comments in which commenters address speci fic CPT/HCPCS codes and provide rationale for their objections to our refinements in the form of new information supporting the inclusion of the items and/or times requested. When discussing these refinement s, rather than listing all refinements made for each service, we discuss only the specific refinements th at meet these criteria. We indicate the presence of other refinements by noting “among other refinements” after delineating the specific refinements for a particular service or group of services. For those comments that stated that an item was “necessary for

the service” and no additional rationale or eviden ce was provided, we conducted further review to

### CMS-1600-FC 269

determine whether the inputs as refined were appropr iate and concluded that the inputs as refined were indeed appropriate. Further, in the CY 2013 PFS correction notice ( 78 FR 48996), we addressed several technical and typographical errors that respond to comments received. We do not repeat those comments nor provide our responses for those items here. (1) Cross-Family Comments

Comment : We received comments regarding refinements to equipment times for many procedures, in which commenters indicated that the equipment time for the procedure should include the time that the equipment is unavailable for other patients, including while preparing equipment, positioning the patient, assisting the physician, and cleaning the room. Response : As stated above, we agree with comment ers that the equipment time should include the times within the intraservice period when a clin ician is using the piece of equipment plus any additional time the piece of equipment is not available for use for another patient due to its use during the designated procedure. We believe that some of these commenters are suggesting that we should allocate

the full number of clinical labor minutes included in the service period to the equipment items. However, as we have explained, the clinical labor service peri od includes minutes based on some clinical labor tasks associated with preservice and postservice activities that we do not believe typically preclude equipment items from being used in furnishing services to other patients because these activit ies typically occur in

other rooms. The equipment times allocated to the CPT codes in Table 25 already include the full intraservice time the equipment is typically used in furnishing the servi ce, plus additional minutes to reflect time that the equipment is unavailable for use in furnishing services to other patients. TABLE 25: Equipment Inputs that Include Appropriate Clinical Labor Tasks About Which Comments Were Received

CPT Code Equipment Items 50590 EQ175

### CMS-1600-FC 270

CPT Code Equipment Items 52214 all items 52224 all items 72040 EL012 72050 EL012 72052 EL012 72192 EL007 72193 EL007 72194 EL007 73221 EL008 73721 EL008 74150 EL007 74160 EL007 74170 EL007 74175 EL007 74177 EL007 74178 EL007 77301 ER005 78012 ER063 78013 ER032 78014 EF010, ER063 78070 ER032 78071 ER032 93925 EL016 93926 EL016 93970 EL016

Comment : Some commenters stated that selected items added to various CPT codes during clinical review by CMS were not typical. In Table 26, we list those services and items identified by commenters as atypical for the service. For each of these items, we note whether we maintained our refinement or removed the input based on commenter recommendation. In general, we have accepted the comments to remove the items, except when we belie ved that doing so would deviate from our standard policies. Specifically, as we discuss above, we are main taining standard times for clinical labor tasks; these include 10 minutes for “clean surgical instrume nt package” for CPT codes 11301 – 11313, the time

### CMS-1600-FC 271

for “Assist physician in performing procedure” to conf orm to physician time for CPT code 13150, and the equipment minutes used exclusively for the patient for “lane, screening (oph)” (EL006) for CPT codes 92081, 92082, and 92083.

TABLE 26: Items Identified As Not Typical By Commenters

CPT Code/ Code Range CMS Code CMS Code Description Labor Activity (If Applicable) AMA RUCRecommendation CMS Refinement CommenterRecommendation CMS Decision/ Rationale

11301- 11313 L037D RN/LPN/MTA Clean Surgical Instrument Package 1 10 1 Maintain refinement/

Standard

Time

13150 L037D RN/LPN/MTA Assist physician in performing procedure 20 26 20 Maintain refinement/

Standard

Time SA067 tray, shave prep 0 1 0 Removed SB001 cap, surgical 0 2 0 Removed 32554 SB039 shoe covers, surgical 0 2 0 Removed

SA044 pack, moderate sedation 0 1 0 Removed SA067 tray, shave prep 0 1 0 Removed SB001 cap, surgical 0 2 0 Removed SB039 shoe covers, surgical 0 2 0 Removed

SC010 closed flush system, angiography 0 1 0 Removed

SH065 sodium chloride 0.9% flush syringe 0 1 0 Removed 32556

SH069 sodium chloride 0.9% irrigation (500-1000ml uou) 0 1 0 Removed

SB027 gown, staff, impervious 0 1 0 Removed 32557 SG078 tape, surgical occlusive 1in 0 25 0 Removed

### CMS-1600-FC 272

CPT Code/ Code Range CMS Code CMS Code Description Labor Activity (If Applicable) AMA RUCRecommendation CMS Refinement CommenterRecommendation CMS Decision/ Rationale (Blenderm)

67810 SB011 drape, sterile, fenestrated 16in x 29in 0 1 0 Removed

SK076 slide sleeve (photo slides) 0 1 0 Removed 72192 SK098 film, x-ray, laser print 0 8 4 Removed

SH065 sodium chloride 0.9% flush syringe 0 15 1 Removed 72193 SK076 slide sleeve (photo slides) 0 1 0 Removed

SK076 slide sleeve (photo slides) 0 1 0 Removed 74150 SK098 film, x-ray, laser print 0 8 4 Removed

74160 SH065 sodium chloride 0.9% flush syringe 0 15 1 Removed

74170 SH065 sodium chloride 0.9% flush syringe 0 15 1 Removed

92081 EL006 lane, screening (oph) 12 17 12 Maintain refinement/

Standard

Time

92082 EL006 lane, screening (oph) 22 27 22 Maintain refinement/

Standard

Time

92083 EL006 lane, screening (oph) 32 37 32 Maintain refinement/

Standard

Time

93017 L051A RN Complete diagnostic forms, lab & X-ray 0 4 0 Removed

### CMS-1600-FC 273

CPT Code/ Code Range CMS Code CMS Code Description Labor Activity (If Applicable) AMA RUCRecommendation CMS Refinement CommenterRecommendation CMS Decision/ Rationale requisitions

(2) Integumentary system: Skin, Subcutaneous, and Accessory Structures (CPT codes 11300, 11301, 11302, 11303, 11305, 11306, 11307, 11308, 11310, 11311, 11312, 11313) In establishing interim final direct PE inputs for CY 2013, CMS refined the AMA RUC’s recommendation for CPT codes 11300 (Shaving of epidermal or dermal lesion, single lesion, trunk, arms or legs; lesion diameter 0.5 cm or less), 11301 (Sha ving of epidermal or dermal lesion, single lesion, trunk, arms or legs; lesion diameter 0.6 to 1.0 cm), 11302 (Shaving of epidermal or dermal lesion, single lesion, trunk, arms or legs; lesion diameter 1.1 to 2. 0 cm), 11303 (Shaving of epidermal or dermal lesion, single lesion, trunk, arms or legs; lesion diameter over 2.0 cm), 11305 (Shaving of epidermal or dermal lesion, single lesion, scalp, neck, hands, feet, genita lia; lesion diameter 0.5 cm or less), 11306 (Shaving of epidermal or dermal lesion, single lesion, scalp, neck, hands, feet, genitalia; lesion diameter 0.6 to 1.0 cm), 11307 (Shaving of epidermal or dermal lesion, single lesion, scalp, neck, hands, feet, genitalia; lesion diameter 1.1 to 2.0 cm), 11308 (Shaving of epid ermal or dermal lesion, single lesion, scalp, neck, hands, feet, genitalia; lesion diameter over 2.0 cm), 11310 (Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous memb rane; lesion diameter 0.5 cm or less), 11311 (Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter 0.6 to 1.0 cm), 11312 (Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter 1.1 to 2.0 cm), and 11313 (Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter over 2.0 cm) by removing “electrocautery-hyfrecator, up to 45 watt s” (EQ110), and “cover, probe (cryosurgery)” (SB003), among other refinements.

Comment : Commenters noted that there is an “inherent and persistent risk of bleeding” during these procedures, and that the electrocautery-hyfrecator needs to be readily ava ilable to prevent excessive

### CMS-1600-FC 274

blood loss and is typically included in the surgical field. These commenters explained that the item, “cover, probe (cryosurgery)” is th e generic sterile sheath that covers the electrocautery-hyfrecator penhandle and cable, and therefore required to be used with the electrocautery-hyfrecator. Response : In our clinical review, we reviewed the work vignettes for these procedures, which did not include the use of the electrocautery-hyfrecator as a part of the procedure. Although we acknowledge that the electrocautery-hyfrecator needs to be read ily available during the procedure, we note that “standby” equipment, or items that are not used in the typical case, are considered indirect costs. For further discussion of this issue, we refer readers to our discussion of “standby” equipment in the CY 2001 PFS proposed rule (65 FR 44187). With regard to the “cover, probe (cryosurgery)”, this item is a disposable supply that would only be used with each patient if the electrocautery-hyfrecator is in the sterile field during all procedures. We do not have information to suggest that the electrocauteryhyfrecator is typically in the sterile field, so we are not including the supply item “cover, probe (cryosurgery)” in the direct PE database for this ser vice. After consideration of the comments received, we are finalizing the CY 2013 interim final direct PE inputs for 11300-11313 as established. (3) Integumentary System: Repair (Closure) (CPT Codes 13100, 13101, 13102, 13120, 13121, 13122, 13131, 13132, 13133, 13152, and 13153) In establishing interim final direct PE inputs for CY 2013, CMS refined the AMA RUC’s recommendations for CPT codes 13100 (Repair, complex, trunk; 1.1 cm to 2.5 cm), 13101 (Repair, complex, trunk; 2.6 cm to 7.5 cm), 13102 (Repair, co mplex, trunk; each additional 5 cm or less (list separately in addition to code for primary procedure) ), 13120 (Repair, complex, scalp, arms, and/or legs; 1.1 cm to 2.5 cm), 13121 (Repair, complex, scalp, arms, and/or legs; 2.6 cm to 7.5 cm), 13122 (Repair, complex, scalp, arms, and/or legs; each additional 5 cm or less (list separately in addition to code for primary procedure)), 13131 (Repair, complex, foreh ead, cheeks, chin, mouth, neck, axillae, genitalia, hands and/or feet; 1.1 cm to 2.5 cm), 13132 (Repair, complex, forehead, cheeks, chin, mouth, neck, axillae, genitalia, hands and/or feet; 2.6 cm to 7.5 cm), 13133 (Repair, complex, forehead, cheeks, chin, mouth, neck, axillae, genitalia, hands and/or feet; eac h additional 5 cm or less (list separately in addition

### CMS-1600-FC 275

to code for primary procedure)), 13150 (Repair, comple x, eyelids, nose, ears and/or lips; 1.0 cm or less), 13151 (Repair, complex, eyelids, nose, ears and/or lips; 1.1 cm to 2.5 cm), 13152 (Repair, complex, eyelids, nose, ears and/or lips; 2.6 cm to 7.5 cm), and 13153 (Repair, complex, eyelids, nose, ears and/or lips; each additional 5 cm or less (list separately in addition to code for primar y procedure)) by removing duplicative items, among other refinements.

Comment : A few commenters argued that the majority of procedures reported using CPT codes 13100, 13101, 13120, 13121, 13131, 13132, 13150, 13151, and 13153 are furnished under local anesthesia, delivered by subcutaneous injection, and therefore typically require “needle, 18-27g” (SC029). Commenters also pointed out that the sec ond “gown, staff, impervious” (SB027) and “mask, surgical” (SB033) are not duplicative, but required, because an assistant at su rgery is allowed for these surgeries in some cases, and OSHA requirements mand ate that health care workers be protected from blood exposure. Commenters stated that they did not believe these procedures could be furnished without these inputs. Response : Based on the rationale provided by comment ers, we agree that the needle should be included as a direct PE input for this family of cod es. However, we continue to believe that a second gown and mask are not typical because our claims data s how that an assistant at surgery is rarely, if ever,

used for these services. After consideration of the comments received, we are finalizing the CY 2013 interim final direct PE inputs for 13100 – 13153 with the additional refi nement of incorporating the “needle, 18-27g” (SC029) as recommended by commenters. (4) Integumentary System: Nails (CPT Code 11719) In establishing interim final direct PE inputs for CY 2013, we refined the AMA RUC recommendation for CPT code 11719 by adjusting the tim es allocated for clinical labor tasks as follows: “Provide preservice education/obtain consent” from 2 minutes to 1 minute, “Greet patient, provide gowning, assure appropriate medical records are available” from 3 minutes to 1 minute, “Prepare room,

### CMS-1600-FC 276

equipment, supplies” from 2 minutes to 1 minute, and “Clean room/equipment by physician staff” from 3 minutes to 1 minute, among other refinements.

Comment : A commenter objected to our refinements to this clinical labor task, and argued that one minute of “provide preservice education/obtain consent” is inadequate to review the advanced beneficiary notice (ABN) and answer patient questions . This commenter also objected to our decreasing

the number of minutes associated with the other clinical labor activities to below the AMA-RUC

recommended standard minutes. Response : We believe that the time assigned to “p rovide preservice educa tion/obtain consent” appropriately reflects the resources required in furnis hing the typical procedure and thus are not making the change requested, particularly since five minutes of preservice physician time are also included for the service. We also would not expect an ABN to be provided in the typical case. We agree with

commenters that we should allocate the standard num ber of minutes for the remaining clinical labor activities and have adjusted the direct PE database accordingly.

Comment : One commenter suggested that it was typical to position a patient in a power table/chair in lieu of an exam table when furnishing this service. Response : CMS clinical staff reviewed CPT code 11719 in the context of this comment. We do not believe that it is typical that a power table/chai r would be used for these procedures. After considering the comments received, we are finalizing the CY 2013 interim final direct PE inputs for CPT code 11719 as established, with the exception of increasing the minutes assigned to clinical labor activities to the

standard number of minutes. (5) Arthrocentesis (CPT Codes 20600, 20605, 20610). In establishing direct PE inputs for CY 2013, we refined the AMA RUC’s recommendations for CPT codes 20600 (Arthrocentesis, aspiration and/or inject ion; small joint or bursa (eg, fingers, toes), 20605 (Arthrocentesis, aspiration and/or injection; in termediate joint or bursa (eg, temporomandibular, acromioclavicular, wrist, elbow or ankle, olecranon bu rsa)), and 20610 (Arthrocentesis, aspiration and/or injection; major joint or bursa (eg, shoulder, hip, knee joint, subacromial bursa)) by removing the minutes

### CMS-1600-FC 277

associated with the clinical labor activity “discharge day management” and replacing these minutes with “conduct phone calls/call in prescrip tions” in the facility setting.

Comment : Commenters requested clarif ication as to whether the time allocated for “conduct phone calls/call in prescriptions” is limited to the fac ility setting or is also included in the non-facility setting. Response : The AMA RUC recommendation included “conduct phone calls/call in prescriptions” in the nonfacility setting and we did no t refine this recommendation. Theref ore, this activity is included in the inputs for the nonfacility setting as well.

Comment : One commenter suggested it was typical for a physician to position a patient in a power table/chair in lieu of an exam table when furnishing 20600 and 20605. Response : Our clinical staff reviewed CPT codes 20600 and 20605 in the context of this

comment. We do not believe that it is typical that a power table/chair would be used for these procedures. After considering the comments received, we are fina lizing the CY 2013 interim final direct PE inputs for CPT codes 20600, 20605, and 20610 as established. (6) Respiratory System: Accessory Sinuses (CPT Code 31231) In establishing interim final direct PE inputs for CY 2013, we refined the AMA RUC’s recommendation for CPT code 31231 (Nasal endoscopy, diagnostic, unilateral or bilateral (separate procedure)) by removing the second “endoscope, rigid, sinoscopy” (ES013) from the inputs for the service, refining the equipment time to reflect typical use exclusive to the patient, and removing the time allocated to preservice clinical labor tasks, among other refinements.

Comment : A commenter disagreed with our removal of the second endoscope, arguing that the second scope is medically necessary because the firs t scope (zero degree rigid scope) does not allow visualizing above or behind all the normal structures of the nasal va ult such as superior turbinate and the frontal recess. The second scope (for example, a 30, 45 or 70 degree scope) is used more than 51 percent

of the time.

### CMS-1600-FC 278

Response : We agree with the commenter that the sec ond scope is used in the typical case, and based on this comment; we are adding the second scope to the direct PE inputs for the service.

Comment : A commenter disagreed with our refineme nts to the equipment time for this service, and stated that the entire clinical labor service period time of 63 minutes, and at a minimum, 43 minutes, should be allocated to all equipm ent used in this procedure. Response : In general, for equipment that we do not consider to be highly technical, we allocate the entire service period time, with the exception of the time allocated for cleaning of other, portable pieces of equipment. Therefore, we agree with the commenter that the equipment times should be modified, but do not agree with the commenter that 63 minutes should be allocated. Instead, we are modifying the time allocated for the equipment in this procedure by assigning 53 minutes to the instrument pack to reflect the intraservice time othe r than cleaning of the scopes, 48 minutes to the scopes

to reflect the intraservice time other than the clean ing of the instrument pack, and 38 minutes to the remaining equipment items, which reflects the entire intraservice clinical labor time except for the time allocated for cleaning the portable equipm ent items instrument pack and scope.

Comment : Commenters argued that the preservice clin ical labor tasks included in the RUC recommendation should have been maintained in this procedure. Response : This procedure is typically billed with an E/M service, and the preservice tasks are already included as direct PE inputs for the E/M servi ces. Therefore, we believe that including these items again in CPT 31231 would be duplicative. After consideration of public comments, we ar e finalizing the CY 2013 interim final direct PE inputs for 31231 as established with the additional re finements of adding in the second scope as an equipment item and adjusting the equipment times as discussed above. (7) Respiratory System: Lungs and Pleura (CPT Codes 32554, 32555, and 32557) In establishing interim final direct PE input s for CY 2013, we refined the AMA RUC’s recommendation for CPT codes 32554 (Removal of fluid from chest cavity), 32555 (Removal of fluid from chest cavity with imaging guidance), and 32557 (Removal of fluid from chest cavity with insertion

### CMS-1600-FC 279

of indwelling catheter and imaging guidance), by inser ting supply item “kit, pleural catheter insertion” (SA077) and refining the equipment times to refl ect the typical use exclusive to the patient.

Comment: Commenters indicated that a tunneled cat heter is not used during this procedure, so that the pleural catheter insertion kit is not an accura te supply item to use as the thoracentesis kit (SA113). The commenter also pointed out that the price of the thoracentesis kit that appears in the direct PE input database appeared to be inaccurately priced at $260.5 9. The commenter pointed out that the price listed

in the database reflects an invoice that includes ten units , so that the accurate price for the items is $26.06. Response : Based on the information provided by co mmenters, we agree that supply item “Kit, thoracentesis” (SA113) would be more appropriate than “kit, pleural cat heter insertion” (SA077) and we agree that the correct price for the item is $26.06. We have updated this price in the direct PE input database accordingly.

Comment : Commenters stated that th e time allocated to equipment items “room, ultrasound, general” (EL015) and “room, CT” (EL007), as well as “light, exam” (EQ168) should reflect the time for tasks during which the room is not available to ot her patients; specifically, for CPT code 32555, 33 minutes should be assigned to EL015, and for CPT code 32557, 45 minutes should be assigned to EL007 and EQ168. Response : We agree with commenters that it is consis tent with our stated policy to allocate time for highly technical equipment for preparing th e room, positioning the patient, acquiring images, and cleaning the room. Therefore, for CPT code 32555, we are assigning 33 minutes to “room, ultrasound, general” (EL015), and for CPT c ode 32557, we are assigning 45 minutes to “room, CT” (EL007) and “light, exam” (EQ168). After reviewing the public comments received, we are finalizing the CY 2013 interim final direct PE inputs for CPT codes 32554, 32555, and 32557 as established with the additional refinements of including and updating the price of the “kit, th oracentesis” (SA113) supply item and adjusting the equipment times as commenters recommended.

### CMS-1600-FC 280

(8) Cardiovascular System: Heart and Pericardium (CPT codes 33361, 33362, 33363, 33364, 33365, and 33405) In establishing interim final direct PE inputs for CY 2013, we refined the AMA RUC’s recommendation for CPT codes 33361, 33362, 33363, 33364, and 33365 by refining the time allocated to clinical labor tasks in the preservice and postservice periods to be consistent with the standards for adjusted 000-day global services.

Comment : Commenters stated that these services are furnished in a facility setting, requiring a fully equipped operating room or hybrid suite. The co mmenter detailed the various clinical labor tasks that are needed for these procedures, and noted that the requirements are similar to those of 90-day global procedures. Response : We agree with commenters that it would be appropriate to allocate the standard 90- day global clinical labor inputs for these services. After consideration of public comments, we are finalizing the CY 2013 interim final direct PE inputs for CPT codes 33361-33365 as established, with the additional refinement of replacing the current times for clinical labor tasks with those of the standard 90- day global inputs. We also refined the direct PE inputs for CPT c ode 33405 by removing the clinical labor activity, “Additional coordination between multiple specialties for complex procedures (tests, meds, scheduling, etc.) prior to patient arrival at site of service.”

Comment : A commenter stated that inclusion of the time allocated for this additional coordination activity is consistent with other major surgical procedures, and that removing it would create an anomaly with other cardiac procedures. Response : We do not agree that it is appropriate to include these “additional coordination” tasks as inputs to this procedure. We thank the commenter for bringing to our attention the potential anomaly created by having this activity included in othe r procedures and will consider any relativity issues regarding clinical labor preservice minutes allocated for other procedures in future rulemaking. After

### CMS-1600-FC 281

consideration of the comments received, we are fi nalizing the CY 2013 direct PE inputs for CPT code

33405 as established. (9) Cardiovascular System: Arteries and Veins (CPT codes 36221, 36222, 36223, 36224, 36225, 36226, 36227, 36228, and 37197) In establishing interim final direct PE input s for CY 2013, we refined the AMA RUC’s recommendation for CPT codes 36221 (Insertion of cathete r into chest aorta for diagnosis or treatment), 36222 (Insertion of catheter into neck artery for diag nosis or treatment), 36223 (Insertion of catheter into neck artery for diagnosis or treatment), 36224 (Inserti on of catheter into neck artery for diagnosis or treatment), 36225 (Insertion of catheter into chest arte ry for diagnosis or treatment), 36226 (Insertion of catheter into chest artery for diagnosis or treatment), and 36227 (Insertion of catheter into neck artery for diagnosis or treatment) by substituting equipment item “table, instrument, mobile” (EF027) for equipment item “Stretcher” (EF018), refining equipment time to reflect typical use exclusive to the patient for equipment items “room, angiography” (EL011), “contrast media warmer” (EQ088), and “film alternator (motorized film viewbox)” (ER029), and removing th e recommended minutes based on the clinical labor task described as “image post processing” fro m CPT code 36221, among other refinements.

Comment : Commenters stated that they believed that the removal of the stretcher was an error because a stretcher is necessary for these cerebral angi ography codes and requested that the stretcher be included as an input for these procedures. Response : We do not agree with commenters that it is a ppropriate to include a stretcher for this family of codes. The inclusion of a stretcher is not consistent with the AMA RUC-recommended standardized nonfacility direct PE inputs that account for moderate sedation as typically furnished as a part of such service, which we used as the basis for proposing and finalizing a standard package of direct PE inputs for moderate sedation during CY 2012 rulema king. For further discussion of this issue, we refer readers to the CY 2012 PFS rule (76 FR 73044).

Comment : Commenters stated the CMS refinement for equipment minutes was inappropriate, and that the equipment time for “room, angiography” (EL011), “contrast media warmer” (EQ088), and

### CMS-1600-FC 282

“film alternator (motorized film viewbox)” (ER029) s hould include the clinical labor tasks of “prepare room,” “prepare and position patient,” “sedate patie nt,” “assist physician/acquire images,” and “clean room.” Specifically, commenters requested that we ad just the time for all equipment items as follows: 49 minutes for CPT code 36221, 59 minutes for CPT code 36222, 64 minutes for CPT code 36223, 69 minutes for CPT code 36224, 64 minutes for CPT code 36225, and 69 minutes for CPT code 36226. Response : We agree with commenters that the tim e allocated to the equipment should account for these tasks. We are adjusting the equipment ti mes for “room, angiography” (EL011), “contrast media warmer” (EQ088), and “film alternator (motorized film viewbox)” (ER029) to those identified by the

commenters and described above.

Comment : A commenter noted that “image post processing” often appears as a clinical labor task activity on the PE worksheet and that the task is integr al to patient care for the services described by these codes. Commenters requested that we include th ese clinical labor tasks for these procedures. Response : Upon further review of similar codes, we agree with the commenter that it is consistent with other services in this family to in clude clinical labor minutes based on the “image post processing” task. After consideration of public comme nts, we are finalizing the CY 2013 interim final direct PE inputs for CPT codes 36221 - 36227 as estab lished with the additional refinements of the adjusted equipment and clinical labor times noted above. We also refined the AMA RUC’s recommendation for direct PE inputs for CPT code 36228 (Insertion of catheter into neck artery for diagnosis or treatment) by removing 1 minute of clinical labor time, based on the task called “prepare room, equipm ent, and supplies,” and 1 minute for “assisting with fluoroscopy/image acquisition.” We also refined th e recommendation by not including the supply item “syringe, 5-6 ml” (SC075).

Comment : Commenters stated that the additional mi nute for “prepare room, equipment, and supplies” is necessary for this add-on code. They al so requested that we adjust the time for acquiring images as well. Commenters also stated that the syri nge is necessary to safely inject micro-catheters and

should be included.

### CMS-1600-FC 283

Response : We do not agree with commenters that an additional minute should be added to the

clinical labor time for this add-on code to account for additional time to “prepare the room, equipment, and supplies.” As we stated in the CY 2013 PFS fi nal rule with comment pe riod (77 FR 68933), we believe that preparing the room would not typically be duplicated when furnishing a subsequent procedure to the same patient on the same day, and we believe that the standard number of minutes

allocated on the basis of the clinical labor task accounts for the typical amount time spent preparing the items for the primary procedure, regardless of whether or not a separate code is reported for some cases. However, based on the commenters’ explanation, we agree that an additional minute for image acquisition is typical when the add-on code is reporte d. We also agree that the syringe is necessary for this procedure. After reviewing public comments received, we are finalizing the CY 2013 direct PE inputs for

CPT code 36228 as established with th e additional refinements to the clinical labor and supply items

noted above. In establishing interim final direct PE inputs for CY 2013, we refined the AMA RUC’s recommendation for CPT code 37197 (Retrieval of intravascular foreign body) by removing equipment items “ultrasound unit, portable” (EQ250) and “cont rast media warmer” (EQ088), and supply items “sheath-cover, sterile, 96in x 6in (transducer)” (SB048), “catheter, (Glide)” (SD147), “guidewire, Amplatz wire 260 cm” (SD252), and “sodium chloride 0.9% flush syringe” (SH065).

Comment : Commenters indicated that the portable ultrasound unit is necessary to gain vascular access, the contrast media warmer is necessary for th e procedure, and the supply items we refined from the AMA RUC recommendation are also required for the procedures since the foreign body cannot be

removed without these items. Response : We do not agree that the portable ultrasound unit should be included as a direct PE input for this procedure. The CPT description of this code states that either fluoroscopy or ultrasound is used; the angiography room accounts for the resources as sociated with fluoroscopy. When fluoroscopy is used, these resources are appropriately accounted for. In the event that a portable ultrasound unit is used

### CMS-1600-FC 284

in place of fluoroscopy, the resource costs would be significantly overestimated, since a portable ultrasound unit is far less expensive than the angiography room. Therefore, we continue to believe that the PE inputs adequately account for the resource costs used for imaging in this procedure. We also continue to believe that the supply items we refined from the AMA RUC recommendation are duplicative since the inputs for this service already include supply items that are used for removing the foreign body during the procedure. We agree with commenters that the c ontrast media warmer should be included in the procedure, and are including this equipmen t item as a direct PE input for this service. After consideration of these comments, we ar e finalizing the CY 2013 interim final direct PE inputs for CPT code 37197 as established with the ad ditional refinement of adding the equipment item “contrast media warmer” (EQ088), as noted above. (10) Digestive System: Intestines (Except Rectum) (CPT code 44705 and HCPCS code G0455) In establishing interim final direct PE inputs for CY 2013, CMS crosswalked the inputs from 44705 (Prepare fecal microbiota for instillation, including assessment of donor specimen) to G0455 (Preparation with instillation of fecal microbiot a by any method, including assessment of donor specimen), and incorporated a minimum multi-specialt y visit pack (SA048) and an additional 17 minutes of clinical labor time in the service period based on the amount of time allocated for clinical labor tasks in the direct PE inputs for E/M services. In the CY 2013 final rule with comment period, we noted that Medicare would only pay for the preparation of the do nor specimen if the specimen is ultimately used for the treatment of a beneficiary. Accordingly, we bundled preparation and ins tillation into a HCPCS code, G0455, to be used for Medicare beneficiaries instea d of the new CPT code 44705 (Preparation of fecal microbiota for instillation, including assessment of donor specimen), which we assigned a PFS procedure status indicator of I (Not valid for Medicare purposes). G0455 includes both the work of preparation and

instillation of the microbiota.

Comment : A commenter asserted that CMS listed G0455 as having a PE RVU of 2.48 without explaining how this value was derived.

### CMS-1600-FC 285

Response : In the CY 2013 PFS final rule with comment period (77 FR 69073), we described how we established the direct PE inputs for G0455. Sp ecifically, we stated that we used the AMA RUCrecommended nonfacility PE inputs for CPT code 44705, in addition to 17 minutes of clinical labor time and a “minimum multi-specialty visit pack” (SA048), to account for both the preparation and instillation.

The PE RVU of 2.48 results from the standard me thodology outlined in PFS rules in the section entitled “Resource-Based Practice Expense (PE) Relative Valu e Units (RVUs)” (see, for example, 77 FR 68899). After consideration of the public comment, we are fi nalizing the interim final direct PE inputs for HCPCS

code G0455 as established. (11) Digestive System: Biliary Tract (CPT Codes 47600 and 47605) In establishing interim final direct PE inputs for CY 2013, we refined the AMA RUC’s recommendation for CPT codes 47600 (Removal of gallb ladder) and 47605 (Removal of gallbladder with X-ray study of bile ducts) by replacing the supply item “pack, post-op incision care (suture & staple) ” (SA053) with supply item “pack, post-op incision care (suture)” (SA054).

Comment : Commenters stated that a lthough sutures and staples ar e sometimes both used, at a minimum, staples are used in this procedure. Ther efore, commenters requested that, as a minimum, we include the staple removal pack. Response : We agree with the commenters that th e staple removal pack (SA052) should be included instead of the suture pack. After consider ation of these comments, we are finalizing the CY 2013 interim final direct PE inputs for CPT codes 47600 and 47605 as established, with the additional refinement of substituting the staple removal pack (SA052) for the suture removal pack (SA054). (12) Urinary System: Bladder (CPT Codes 52214, 52224, and 52287)

In establishing the interim final direct practice expense inputs for CY 2013 for CPT code 52214,

we refined the AMA RUC recommendation to remove supply items “drape-towel, sterile, 18in x 26in” (SB019),“lidocaine 1%-2% inj (Xylocaine)” (SH047), and “penis clamp.”

Comment : Commenters indicated that the supply item “drape-towel, sterile, 18in x 26in,” is used on the instrument table and that the supply item “li docaine 1%-2% inj (Xylocaine)” (SH047), is used to

### CMS-1600-FC 286

instill into the bladder as a numbing agent. Commenters also indicated that the item “penis clamp” is required to keep the lidocaine in the penile urethra. Response : We agree with commenters that the drap e towel and lidocaine should be included in this procedure. However, we do not agree that the reusable penis clamp, even when typically used, should be included in the direct PE input database for this procedure. Since the item is reusable, the

resource cost associated with the item is not consider ed to be a direct PE supply input. Given the price associated with the item, the cost per minute over sever al years of useful life becomes negligible relative to the other costs accounted for in the PE methodology . We refer readers to a discussion of equipment items under $500 in the NPRM for CY 2005 (69 FR 47494). We note that including such items as equipment in the direct PE input database would not impact the PE RVU values. In establishing the interim final direct practice expense inputs for CY 2013, we refined the AMA RUC recommendation for CPT code 52224 by adjusting the equipment time for “fiberscope, flexible, cystoscopy” (ES018) to 94 minutes, adjusting the clinical labor activity “prepare biopsy specimen” to 2 minutes, and adjusting the quantity of the supply item “gloves, sterile” (SB024) to 1 pair, and “cup, biopsy-specimen sterile 4oz” (SL036) to 3, among other refinements.

Comment : Commenters stated that th e time for this equipment item should include all standard tasks, in addition to the cleaning of the scope. Commenters also noted that, depending upon the number of biopsies, the preparation of the specimen can take more than 2 minutes, that a minimum of 3 pairs of gloves are required, and that biopsy specim ens are submitted in several containers. Response : We re-examined the time for the fiberscope and agree with commenters that the time

should include all time associated with standard task s and cleaning the scope. We are therefore adjusting the time for this equipment item to 97 minutes. We c ontinue to believe that 2 minutes represents the typical time required to prepare the specimen and are not adjusting the time. We agree with commenters that more than 1 pair of gloves may be required; how ever, since a biopsy is not required in all cases, we believe that 2 pairs of gloves accounts for the resour ces used in furnishing the typical service. Finally,

we continue to believe that 3 cont ainers represent the typical resources used in furnishing this procedure

### CMS-1600-FC 287

given the small size of the lesions. After considering the comments received, we are finalizing the CY 2013 interim final direct PE inputs for CPT code 52 224 as established with the additional refinement of adjusting the equipment time to account for cleaning the scope, and adding one pair of gloves, as noted

above. In establishing interim final direct PE inputs for CY 2013, we refined the AMA RUC’s recommendation for CPT code 52287 by adjusting th e time for the clinical labor activity “assist physician in performing procedure” from 20 minutes to 21 minutes to conform to the physician intraservice time, and refining the equipment time to re flect the typical use exclus ive to the patient.

Comment : The AMA RUC stated that its original submission to CMS contained 21 minutes for this clinical labor activity. Another commenter noted that the times allocated to preservice clinical labor tasks were missing in the nonfacility setting. Another commenter stated that the equipment time should

include the time for all of the standard clinical labor tasks. Response : We note that the AMA RUC and CMS agree on the appropriate number of minutes to assign to the clinical labor service period to account for “assist physician.” Regarding the preservice clinical labor tasks, we note that the AMA RUC di d not recommend preservice clinical labor time for these tasks in the nonfacility setting, and that such in puts are not standard for 000-day global services. With respect to equipment time, we agree with comme nters that the equipment time for all equipment in this procedure should include time for all of the standa rd clinical labor tasks, with the exception of the time allocated for cleaning of the scope. The times fo r the equipment items included in CPT code 52287 already include all of these tasks, with the exception of “fiberscope, flexible, cystoscopy” (ES018). We are adjusting time for the scope from 76 to 78 minutes to align the equipment time with that of the

standard clinical labor tasks. After considering the comments received, we ar e finalizing the CY 2013 interim final direct PE inputs for CPT code 52287 as established with the add itional refinement of adjusting the equipment time

as noted above. (13) Transurethral Destruction of Prostate Tissue (CPT Code 53850)

### CMS-1600-FC 288

In establishing interim final direct PE inputs for CY 2013, we refined the AMA RUC’s recommendation for CPT code 53850 by refining equipmen t time to reflect typical use exclusive to the patient.

Comment : A commenter stated that the equipment time should include the time for all of the

standard clinical labor tasks. Response : We agree with the commenter that the equipment time for all equipment in this procedure should include time for all of the standard clinical labor tasks, and we are allocating the entire service period of 99 minutes for “stretcher, endosco py” (EF020), “table, instrument, mobile” (EF027), “TUMT system control unit” (EQ037), and “ultrasoun d unit, portable” (EQ250), which are used during the service period only. In addition, we are allocating 169 minutes for items used during both the service period and postservice period, which are “table, pow er” (EF031) and “light, exam” (EQ168), to account for the both the service period and postservice period.

We also refined the AMA recommendation for this code by not assigning additional clinical labor

minutes for non-standard clinical labor tasks described as “setup ultrasound probe,” “setup TUMT machine,” and “clean TUMT machine.”

Comment : The same commenter also stated that th e clinical labor tasks were necessary because extra time was required. Response : We do not agree that the time for these clin ical labor tasks is reflective of typical resource costs involved in furnishing the service. For this procedure the assigned clinical labor time already includes the standard number of minutes for set-up and clean-up, and the commenter provided no information justifying a deviation from th ese standard times for this procedure.

Comment : A commenter stated that there is no preservice clinical staff time assigned for the nonfacility, and that the clinical labor time should account for tasks such as “setting up the room,” “greeting patient,” and “position pa tient prior to the procedure.” Response : The clinical labor tasks referred to by the commenter are tasks generally included in service period activities; the preservice clinical staff tim e that is included when the procedure is done in

### CMS-1600-FC 289

the facility includes scheduling and coordination services that are uni que to procedures furnished in facility settings. The service period time for this proc edure includes minutes allocated for clinical labor tasks such as “greet patient,” “provide gowning,” “en sure appropriate medical records are available,” and “prepare and position patient.” Therefore, we are not making a change at this time and are finalizing the CY 2013 interim final direct PE inputs for CPT code 53850, including the clinical labor tasks, as

established. (14) Nervous System: Extracranial Nerves, Peri pheral Nerves, and Autonomic Nervous System (CPT Code 64615) In establishing interim final direct PE input s for CY 2013, we accepted the AMA RUC’s recommendation for CPT code 64615 (Injection of chemic al for destruction of facial and neck nerve muscles).

Comment : A commenter questioned why this service had only 3 minutes of postservice clinical labor time, while other codes in the family have 27 or 30 minutes. Response : The apparent discrepancy between CPT c ode 64615 and the other codes in the family results because CPT 64615 does not have any post-opera tive visits in the global period while the other codes in the family have post-operative visits. Sp ecifically, the 30 minutes of postservice clinical labor time in 64612 are allocated specifically for the post- operative visits. After c onsideration of public comment, we are finalizing the CY 2013 interim final direct PE inputs for CPT code 64615 as

established. (15) Diagnostic Radiology: Abdomen and Pelvis (CPT Codes 72191, 72192, 72193, 72194, 74150, 74160, 74170, 74175, 74176, 74177, 74178) In establishing interim final direct PE inputs for CY 2013, we reviewed the direct PE inputs for all of the abdomen, pelvis, and abdomen/pelvis co mbined CT codes. For each set of codes, we established a common set of disposable supplies and me dical equipment. We established clinical labor minutes that reflect the fundamental assumption that the component codes should include a base number of minutes for particular tasks, and that the number of minutes in the combined codes should reflect

### CMS-1600-FC 290

efficiencies that occur when the regions are examin ed together. Among other refinements, we adjusted the intraservice time for CPT codes 72194, 74160, and 74177 by 2 minutes, 4 minutes, and 6 minutes respectively.

Comment : Commenters stated that more inform ation was required about from where CMS decreased the minutes from the service period for CPT codes 72194, 74160, and 74177. Response : We refined the minutes in the service period such that the aggregate number of

clinical labor minutes reflected in the direct PE input database and used to develop PE RVUs was consistent within this family of c odes. We believe that the aggregate clinical labor time in each clinical service period (preservice period, service period, and postservice period) or aggregate number of minutes for particular equipment items that reflects the tota l typical resource use is more important than the minutes associated with each clinical labor task, whic h are a tool used by the AMA RUC to develop their recommendations. We hope that in reviewing future services, commenters consider the aggregate clinical labor time as well, recognizing that it is the aggregate time that ultimately has implications for payment. Finally, we welcome comments that address the appr opriateness of the number of clinical labor minutes in each service period and the number of equipment minutes for each service. In this refinement process, we also removed supply item “needle, 18–27g” (SC029) and replaced it with “needle, 14–20g, biopsy” (SC025) for CPT codes 72193, 72194, 74160, and 74170.

Comment : Commenters stated that the biopsy needle (SC025) was not appropriate for these services, and that supply item “needle, 18-27g” (S C029) would be more appropriate. In addition,

commenters noted that the “film processor” (ED024) is in use during a portion of the service. Response : We agree with commenters that the “needle, 18-28g” (SC029) is more appropriate for these services, and that the film processor should be in cluded for these codes. We are adjusting the direct PE inputs to include the needle and film pro cessor in CPT codes 72193, 72194, 74160, and 74170. In refining the direct PE inputs, we also substituted a radiologic technologist for a CT technologist for CPT codes 72191 and 74175, and remove d the clinical labor time for “Retrieve prior

### CMS-1600-FC 291

appropriate imaging exams and hang for MD review, verify orders, review the chart to incorporate relevant clinical information” from 72191, 74170, and 74175.

Comment : Commenters stated that a CT technologist was the typical clinical labor type for these CT procedures. Commenters also objected to the re moval of recommended minutes based on the clinical labor activity “Retrieve prior appropriate imaging exam s and hang for MD review, verify orders, review the chart to incorporate relevant clinical informa tion” from CPT codes 72191, 74170, and 74175, and to the reduction of preservice and intraservice clinical labor time in this family of codes. Response : Based on the information provided by commenters, we agree that CPT codes 72191 and 74175 should include a CT technologist rather than a radiologic technologist for CPT codes 72191 and 74175 because the CT technologist is typical. However, we do not agree that the clinical labor time should be changed per the commenters’ request, as we continue to believe that these tasks are already captured in the preservice clinical labor time. We refer readers to the CY 2013 PFS final rule with comment period (77 FR 69073) for a discussion of the de velopment of a standard allocation of inputs for

these families of codes. For CPT code 72191, we refined the time for e quipment item “room, CT” (EL007) to 40 minutes.

Comment : Commenters stated that the CT room time for should be at least 43 minutes to include time for cleaning the room. Response : We agree with commenters that the tim e for the CT room should be 43 minutes to include the standard clinical labor tasks for highly technical equipment, including cleaning the room. After considering the comments received, we ar e finalizing the CY 2013 interim final direct PE inputs for CPT codes 72193, 72194, 73221, 73721, 74150, 74160, 74170, 74175, 74176, and 74177 as established with the additional refinements of the supp ly item, changes to clinical labor staff type, and equipment time noted above. (16) Diagnostic Ultrasound: Transvaginal and Transrectal Ultrasound (CPT Codes 76830 and 76872) In establishing interim final direct PE inputs for CY 2013, we refined the AMA RUC’s recommendation for CPT code 76830 by removing th e equipment item “room, ultrasound, general”

### CMS-1600-FC 292

(EL015) and replacing it with individual items including a portable ultrasound unit. Comment : A commenter noted that a panel of obstetrician/gynecol ogists, a specialty that frequently furnishes this service, indicated that a dedicated ultrasound room was used. Response : Based on the comments we received, we agree that it would be more appropriate to allocate a general ultrasound room for this proce dure rather than a portable ultrasound unit and accompanying items. We are including the ultrasound room as a direct PE input for CPT code 76830. In refining the inputs for CPT code 76830, we al so removed “film alternator (motorized film viewbox)” (ER029), “Surgilube lubricating jelly” (SJ033), and “film processor, dry, laser” (ED024).

Comment : Another commenter stated that the film alte rnator and Surgilube lubricating jelly are required; however, the specialty that most frequently furnishes the service stated that they did not use

either of these items. Response : We continue to believe that neither the film alternator nor the lubricating jelly should be included for this service as, and after considering the comments from the specialty that most frequently furnishes the service, we agree that these are not used in the typical case. After considering the comments received, we ar e finalizing the CY 2013 interim final direct PE inputs for CPT code 76830 as established with the additional refinement of allocating a general ultrasound room and removing individual i nputs related to a portable ultrasound unit. In establishing interim final direct PE inputs for CY 2013, we refined the AMA RUC’s recommendation for CPT code 76872 by adjusting the e quipment time to reflect the typical use exclusive to the patient, and removing clinical labor tasks, “ obtain vital signs,” and “prepare ultrasound probe” from the preservice period; removing “obtain vital signs” from the service period; and removing supply items “drape, sterile, for Mayo stand” (SB012), “iv tubing (extension)” (SC019), “lidocaine 2% jelly, topical (Xylocaine)” (SH048), “alcohol isopropyl 70%” (SJ 001), “lubricating jelly (K-Y) (5gm uou)” (SJ032), “glutaraldehyde 3.4% (Cidex, Maxicide, Wavicide)” (SM018), “glutaraldehyde test strips (Cidex, Metrex)” (SM019), and “sanitizing cloth-wipe (surface, instruments, equipment)” (SM022).

### CMS-1600-FC 293

Comment : Commenters indicated that the equipment tim e allocated for this procedure should be 68 minutes to reflect the time that the equipment is unavailable for other patients. Response : We agree with commenters that the equi pment time for all equipment in this procedure should include time for all of the standard clinical labor tasks in the service period, so we are allocating 42 minutes for those equipment items.

Comment : Commenters noted that it is necessary to obt ain vital signs prior to the service, and that the supplies were necessary for a va riety of purposes outlined in the comment. Response : We do not agree that it is necessary to obtain vital signs in the preservice period in order to determine if the patient becomes hypotensiv e during the service period, but agree that obtaining vital signs in the service period is necessary. We note that we have standard setup times for equipment and do not generally allocate separate time for preparing individual pieces of equipment. After considering the information provided by the commenter s, we are persuaded that the supplies that were removed are necessary for the procedure. Therefore, we are including 3 additional minutes in the service period and reinstating the supplies that we removed fr om the procedure in establishing interim final direct PE inputs. After considering comments received, we are finalizing the CY 2013 interim final direct PE inputs for CPT code 76872 as established with the add itional refinement of adjusting equipment time and incorporating supply items as noted above. (17) Radiation oncology: Medical Radiation Physics, Dosimetry, Treatment Devices, and Special Services (CPT Code 77301) In establishing interim final direct PE input s for CY 2013, we refined the AMA RUC’s recommendation for CPT code 77301 by removing equipment item “computer system, record and verify”from the service, adjusting the equipment time for “treatment planning system, IMRT (Corvus wPeregrine 3D Monte Carlo)” from 376 to 330, among other refinements previously discussed in the context of our discussion of general refinements.

### CMS-1600-FC 294

Comment : Commenters indicated that the minutes used for the computer system are not captured elsewhere and should be included in the service, and th at there is physician time independent of clinical staff time for the treatment planning system. Response : The computer system was not previously an input for this service, and the commenter did not provide sufficient information or evidence for us to conclude that there should be a change. We also note that this service has both a technical and professional component; the professional component has no inputs, and the equipment time associated with the physician time is not appropriately placed in the technical component. Thus, the equipment time is allocated for the technical component only. After considering public comments, we are fi nalizing the CY 2013 interim final direct PE inputs

for CPT code 77301 as established. (18) Nuclear Medicine: Diagnostic (CPT Code 78072) In establishing interim final direct PE inputs for CY 2013, we were unable to price the new equipment item “gamma camera system, single-dual head SPECT/CT” for CPT code 78072 (Parathyroid planar imaging (including subtraction, when perform ed); with tomographic (SPECT), and concurrently acquired computed tomography (CT) for anatomical localization)) since we did not receive any paid

invoices. Because the cost of the item that we were una ble to price is disproportionately large relative to the costs reflected by remainder of the recommended di rect PE inputs, we contractor priced the technical component of the code for CY 2013, on an interi m basis, until the newly recommended equipment item could be appropriately priced.

Comment : A commenter indicated that it would provi de necessary documentation so that CMS can establish a price for the new SPECT/CT equipment item associated with CPT code 78072. We received 4 paid invoices for the SPECT/CT equipment. Response : Out of the four invoices we received, we were only able to use one of them to price the equipment because the other three included training and other costs as part of the overall equipment price. Since training and these other costs are not cons idered part of the price of the equipment in the current PE methodology, we are unable to use invoices when these items are not separately priced on the

### CMS-1600-FC 295

invoice. Based on the invoice that met our criteria, this equipment is priced at $600,272. We are assigning 92 minutes based on our standard allocation for highly technical e quipment, to include “prepare room, prepare and position patient, administer radi opharmaceutical, acquire images, complete diagnostic forms, and clean room.” After reviewing the comments received, we are establishing interim final direct PE inputs for CPT code 78082 and, rather than contractor price the code as we did in 2013, we are pricing

this code under the PFS on an interim final basis for CY 2014. (19) Pathology and Laboratory: Chemistry (CPT Code 86153) In establishing interim final direct PE inputs for CY 2013, we refined the AMA RUC’s recommendation for CPT code 86153 (Cell enumerati on using immunologic selection and identification in fluid specimen (eg, circulating tumor cells in blood)) by valuing the service without direct practice expense inputs.

Comment : Commenters requested that we include direct PE inputs for CPT code 86153, explaining that in the majority of cases, CPT c ode 86152 is submitted wit hout an accompanying 86153

code. Commenters noted that there are clinical labor tasks furnished by a laboratory technician for this

service. Response : CPT code 86153 is a professional component-only CPT code that is a “clinical laboratory interpretation service,” which is one of the current categories of PFS physician pathology services. For this category of services, only services billed with a “26” modifier may be paid under the PFS; the technical component of these services is paid under the Clinical Lab Fee Schedule (CLFS). Generally, under the PFS, RVUs for services billed with a “26” modifier do not include direct PE inputs, since the development of the RVUs for such codes incorporate all associated direct PE inputs in the RVUs for the technical component of the service. When the corresponding laboratory service is billed under the CLFS, the payment accounts for the resource costs involved in furnishing the laboratory service, including the kinds of costs described by the items in the direct PE input database. In addition, we do not believe that it would serve appropriate re lativity to include direct PE inputs for professional component services only when the corresponding technical component payment is made through a

### CMS-1600-FC 296

different Medicare payment system. After consider ation of public comment, we are finalizing our CY

2013 interim final valuation of this service as established. (20) Pathology and Laboratory: Surgical Pat hology (CPT Codes 88300, 88302, 88304, 88305, 88307, 88309) In establishing interim final direct PE input s for CY 2013, we refined the AMA RUC’s recommendation for CPT codes 88300, 88302, 88304, 88305, 88307, and 88309 (Surgical Pathology, Levels I through VI), by not including new supply items “specimen, solvent, and fo rmalin disposal cost,” and “courier transportation costs” and new equipm ent items called “equipment maintenance cost,” “Copath System with maintenance contract,” and “Copat h software.” We stated in the CY 2013 final rule with comment period that we would consider add itional information from commenters regarding whether the Copath computer system and associated software should be considered a direct cost as medical equipment associated with furnishing the technical component of these surgical pathology services. We stated that we were especially interested in unde rstanding the clinical functionality of the equipment in relation to the services being furnished. We al so sought additional public comment regarding the appropriate assumptions regarding the direct PE inputs for these services, as well as independent evidence regarding the appropriate number of blocks to assume as typical for each of these services. We requested public comment regarding the appropriate number of blocks and urged the AMA RUC and interested medical specialty societies to provide corroborating, independent evidence that the number of blocks assumed in the current direct PE input recommendations is typical prior to finalizing the direct PE inputs

for these services.

Comment : Commenters generally rejected the notion th at the items CMS did not accept for this family of codes are indirect costs and asked for a basis for CMS’s statement that disposal costs are

accounted for in the indirect PE allocation. A commenter asserted that it is extremely rare for CMS to not accept direct PE inputs recommended by the AMA RUC. Response : As we noted above and in the CY 2014 PFS proposed rule (78 FR 43292), within the PE methodology all costs other than clinical labor, disposable supplies, and medical equipment are

### CMS-1600-FC 297

considered indirect costs. We note that we freque ntly refine direct PE recommendations from the AMA RUC and address these refinements through rulemaking. Below, we respond to the specific statements by commenters regarding particular items not accepted as direct inputs.

Comment : Commenters stated that specim en, solvent, and formalin disposal costs are variable costs that can be allocated to individual specimens, and noted that these costs ar e not captured in surveys

of indirect costs used for the PFS. Commenters asserted that these costs are proportional to the number of specimens processed each day, and are directly attr ibutable to each case by specimen size and the number of tissue blocks associated with that specimen. Co mmenters pointed to several items in the direct PE database that they believed were anomalous to the spec imen, solvent, and formalin disposal costs that we did not accept. Response : In the CY 2014 PFS proposed rule (78 FR 43293), we addressed the items in the direct PE database brought to our attention by the comment ers. There, we clarified that we believe that a disposable supply is one that is attributable, in its en tirety, to an individual patient for a particular service. We clarified that we believe that supply costs rela ted to specimen disposal attributable to individual services may be appropriately categorized as disposable supplies, but that specimen disposal costs related to an allocated portion of service contracts that cannot be attributed to individual services should not be incorporated into the direct PE input database as dis posable supplies. As we address in section II.B. of this final rule, all costs other than clinical labor, disposable supplies, and medical equipment should be

considered indirect costs in order to maintain relativ ity within the PE methodology. We believe that there are a wide range of costs allocable to individual services that are appropriately considered part of indirect cost categories for purposes of the PE methodology.

Comment : Commenters argued that courier transportation costs are directly allocable to individual beneficiary specimens, and represent a significant practice expense. One commenter stated, “Although more than one specimen may be included in a courier run, still there is a cost per specimen”

and asserted that the indirect PE costs allocated to CPT code 88305 do not adequately account for the sizeable expense of couriers.

### CMS-1600-FC 298

Response : Again, we maintain that all costs other th an clinical labor, disposable supplies, and medical equipment should be considered indirect cost s to maintain relativity within the PE methodology. In addition to not meeting that crite rion to be considered direct PE, the commenter pointed out that more than one specimen may be included in a courier run, so that the cost of courier services does not meet the additional criterion of being “attributable, in its entiret y, to an individual patient for a particular service.” We acknowledge the commenters’ concern that the indi rect costs allocated to CPT code 88305 may not equate to the indirect costs associat ed for every instance a service describ ed by that code is furnished. However, we note that the practice expense methodol ogy is applied consistently throughout the fee schedule, and that the nature of indirect costs is su ch that the costs allocated to an individual procedure

are an estimate of the relative costs associated with th e typical procedure reported with a particular code,

and are not intended to account for those costs on a lin e item basis for each instan ce the code is reported.

Comment : Commenters argued that the maintenance cost s are in fact variable costs in that the costs are proportional to specimen volume. Comme nters acknowledged the 5% equipment maintenance factor that is figured into the costs of equipment inputs to the PE methodology, but argued that pathology laboratories have several equipment items that require more frequent maintenance (in the range of 10% - 12%). Commenters requested that we establis h specialty-specific maintenance factors. Response : We believe that the nature of many equi pment items across the fee schedule is such that the required maintenance would relate, at least in part, to the volume of procedures furnished using the equipment. We note that the established PE methodology does not generally account for either additional costs incurred or efficiencies gained wh en services are furnished in atypical volumes. The equipment maintenance factor is intended to repr esent the typical cost per minute associated with a particular piece of equipment. At this time , our PE methodology does not accommodate equipment maintenance factors that vary by specialty.

Comment : Commenters provided descriptions of the CoPath system, indicating that the system provides procedure support that assists labs with speci men management and tracking, report generation, record storage, workflow automation, management reporting and quality assuran ce functions and support.

### CMS-1600-FC 299

Commenters stated that the CoPath system is a stand- alone system that must be interfaced with the main electronic health care record system, and is unique to pathology and only used by pathology. The CoPath system is required for labs to assign each specimen its unique identifier and associate it with other specimens from the same patient, as well as track the course of the entire process. Commenters also explained that the CoPath sy stem is an advanced pathology information management system for storing and reporting pathology information and accommodates clinical disciplines including surgical pathology, cytology, histology, and autopsy. CoPath manages the integrity of specimen accession and processing, and provides patient history review, patholog y text entry, support for diagnostic coding using the CAP SNOMED database, report generation, case review and sign out, and retrieval for subsequent purposes. It also assists in inputting blocks and interfaces with cassette and slide labelers, querying database for cases, patient histori es, and reducing workload. Commenters compared the Picture Archiving and Communication System (PACS) system for radiologists to the CoPath or equivalent system for pathology. One commenter argued that the clerical and administrative functionality support by a laboratory information system is immaterial to the direct co sts associated with its more prominent utility as the

clinical information infrastructure fo r anatomic pathology laboratories. Response : We asked for comments to help with our u nderstanding of the clinical functionality of the equipment in relation to the services being furn ished. We appreciate the explanations provided, as well as the comparison to the PACS system for ra diologists. Based on our review of the comments received, we understand that this in formation management system is used for a variety of administrative and clerical functions, as well as clinical support func tions. Tools that facilitate the similar functionality for other services, such as the cognitive work involv ed in the professional component, are considered indirect costs under the PFS. For instance, across serv ices furnished by a range of physician specialties, many items that support clinical decision-making are cons idered indirect costs, irrespective of their utility and are not included in the PE methodology as direct costs. Instead, they are part of the indirect category

### CMS-1600-FC 300

of resource costs. As a general principle, for this reason, we do not believe that information management systems are appropriately characterized as direct costs. Furthermore, we believe that the relativity w ithin the PE methodology would be undermined by including these kinds of items as medical equipment onl y for particular kinds of services. We believe that, were we to reconsider the categorization of clinical in formation systems for this particular kind of service, it would be necessary to reconsider the categorizati on of resource costs of other clinical information systems used across PFS servi ces. Therefore, we continue to believe that the CoPath system is best

characterized as an indirect cost that is ca ptured in the indirect cost allocation.

Comment : One commenter suggested that the labor cost of the histotechnologist is closer to 50 cents per minute, rather than the 37 cents pe r minute used in the PE direct inputs database. Response : We did not change the labor cost for histot echnologists in the CY 2013 final rule with comment period. We note, however, that the prices ass ociated with the labor c odes derive from data from the Bureau of Labor Statistics, and we will consider the appropriate time to update all labor category costs in the PE direct inputs database for future rulemaking.

Comment : Commenters disputed the assertion that there is a “typical” case for CPT code 88305, given that there are wide variations in the types of tissues being biopsied. Response : Under the PFS, services are priced based on th e typical case. We continue to seek the best information regarding the inputs in volved in furnishing the typical case.

Comment : Commenters expressed concern that CMS ask ed the AMA RUC to review CPT code 88305 based on the assertion of a single stakeholder th at the clinical vignette used to identify the PE inputs was not typical. Response : As indicated in section II.C.2 of this final rule with comment period, we note that we generally do not identify a code as potentially misval ued solely on the basis of individual assertions. On the contrary, when stakeholders bring information to our attention, it is subject to internal review to

determine whether the code would appropriately be proposed as a pot entially misvalued code, and we offer the public the opportunity to comment prior to finalizing a code as potentially misvalued. We

### CMS-1600-FC 301

followed our standard process in evaluating CPT c ode 88305 as potentially misvalued and reached the conclusion that it was appropriate the refer the service to the AMA RUC. Therefore, we do not agree with

commenters that we asked the AMA RUC to review th is service based solely on information provided by a single stakeholder.

Comment : Some commenters provided information rega rding the number of blocks that is typical for 88305. An association representing pathol ogists argued that there is no typical case for 88305, and provided several vignettes to illustrate the varia tion based on the type of tissue being biopsied. The association also presented findings from one data coll ection effort involving several specialty societies that suggested that the typical number of blocks may be as high as four. However, the association supported the AMA RUC’s recommendation of two blocks as most likely to represent the typical case.

Other commenters indicated that a review of hundred s of cases from multiple ins titutions indicated that the typical, or average, case of 88305 requires one block, not two, and that 92% of cases including pathology, skin pathology, surgi cal pathology, urologic pathology, cell blocks, and bone marrow cases required one block. Another medical specialty indica ted that more than two slide-blocks are routinely required, and requested the use of a modifier for 88305 for those services that routinely require more than two slide-blocks. Another commenter requested that we stratify payment based on the number of blocks. Another commenter suggested that the AMA RUC’s recommended number of clinical labor minutes for

88305 underestimates the amount of clinical labor tim e associated with the typical service described by

the code. Response : Based on the wide range of views expressed in comments, it is difficult to determine the appropriate number of blocks to use in establishi ng direct PE inputs for CPT code 88305. At this time, because we do not have strong evidence to concl ude that a change should be made, are maintaining these values. However, we will continue to seek better information to permit consideration of the appropriate number of blocks, and the appropriate direct PE inputs for this code. We are not establishing

a modifier to differentiate the number of blocks si nce there is not a current billing mechanism to make adjustments based on the number of blocks used when a code is reported.

### CMS-1600-FC 302

Comment : One commenter argued that the practice expense RVU for CPT code 88305 is

insufficient for a tissue exam with two blocks and certa inly insufficient for those exams that require more

than the two blocks and slides than are accounted for in the AMA RUC’s vignette. The commenter argued that even though many tissue biopsies may use an average of two blocks, the valuation of this service does not account for the many kinds of biopsies that use more than two blocks. Another commenter argued that the payment will no longer allow “profits” for 1-2 block specimens to offset the “losses” from specimens that require a larger number of blocks. Response : We acknowledge the commenter’s concern that the valuation of this service is based on two blocks when some services require a greater numb er of blocks. However, this circumstance is not inconsistent with the established PE methodology, which accounts for the relative resources involved in furnishing a typical case for a particular HCPCS c ode. We acknowledge that there are cases that use higher than typical resources, and that there are also cases that use lower than typical resources. As a general principle, we do not believe that the direct inputs associated with a particular PFS service should be established or maintained to result in payment ra tes that might offset outlier cases for that service or support practice expenses for practitioners who furnish lower-paid services. Furthermore, we note that we continue to recei ve feedback regarding th e appropriate coding and code descriptors for surgical pathology for the prosta te needle biopsy services. We believe that revising the code descriptors to ensure that all prostate needle biopsy services with 10 or more specimens are described by the G-codes may facilitate broader consensu s regarding the typical resource costs for 88305. Therefore, for clarity, we are revising the CY 2014 descriptors for these HCPC S codes to include the phrase “any method” following “sampling.” The revised HCPCS code descriptors for microscopi c examination for prostate biopsy are as follows: G0416 (Surgical pathology, gross and microscopic exam ination for prostate needle biopsies, any method; 10-20 specimens), G0417 (Surgical pathology, gross and microscopic examination for prostate needle biopsies, any method; 21-40 specimens), G0418 (Surgi cal pathology, gross and microscopic examination

### CMS-1600-FC 303

for prostate needle biopsies, any method; 41-60 sp ecimens) and G0419 (Surgical pathology, gross and microscopic examination for prostate needle biops ies, any method; greater than 60 specimens). After consideration of public comments receive d, we are finalizing the CY 2013 interim final direct PE inputs for CPT codes 88300- 88309 as established. (21) Pathology and Laboratory: Cytopa thology (CPT Codes 88120 and 88121) In the PFS final rule with comment period, we addressed comments from stakeholders who suggested that CMS increase the price of the supply “UroVysion test kit” (SA105) by building in an “efficiency factor” to account for the kits that are pur chased by practitioners and used in tests that fail. The stakeholders provided documentation suggesting th at a certain failure rate is inherent in the procedure. We indicated that the prices associated with suppl y inputs in the direct PE input database reflect the price per unit of each supply. Since the current PE methodology relies on the inputs for each service reflecting the typical direct practice expense costs fo r each service, and the supply costs for the failed tests are not used in furnishing PFS services, we do not believe that the methodology accommodates a failure rate in allocating the cost of disposable medical suppli es. Therefore, we did not adjust the price input for “UroVysion test kit” (SA105) in the direct PE input database.

Comment : Commenters disagreed with our decision, stating that these are valid expenses and that the inherent failure rate is commonly due to f actors beyond the control of the laboratory or quality of equipment. Further, commenters pointed out that these costs are not reflected in overhead costs, and should therefore be included in direct practice expense inputs. Response : Because the current PE methodology relies on the inputs used in furnishing each service, reflecting the typical direct practice expense costs for each service, we continue to believe that the price of the supply kit should not reflect any failure rate. After consideration of public comment, we are finalizing the CY 2013 interim final direct PE in puts for CPT codes 88120 and 88121 as established. (22) Immunotherapy Injecti ons (CPT codes 95115 and 95117)

### CMS-1600-FC 304

In establishing interim final direct PE inputs for CPT codes 95115 and 95117, we refined theAMA RUC’s recommendation by removing equipment item “refrigerator, vaccine, commercial grade, walarm lock.”

Comment : Commenters indicated that injectable material s need to be refrigerated, and thus the refrigerator should be included for this service. Response : As previously noted, equipment that is used for multiple procedures at once is considered an indirect cost. In future rulemaking, we anticipate reviewing our files for consistency across practice expense inputs in this regard. After consider ation of comments received, we are finalizing the CY 2013 interim final direct practice expense inputs for CPT codes 95115 and 95117 as established. (23) Neurology and Neuromuscular Procedures: Intraoperative Neurophysiology (CPT Codes 95940, 95941 and HCPCS Code G0453) In establishing payment for intraoperative neurophysiology (95940 and G0453) for CY 2013, we did not accept the AMA RUC direct PE input recommendations, since we do not believe that these services are furnished to patients outside of facility settings.

Comment : A commenter noted that hospitals previously owned all of the equipment and supplies and employed the technicians for intraoperative m onitoring. The commenter asserted that, currently, hospitals often use “mobile services” to furnish th ese monitoring procedures, and thus there should be technical component RVUs for these services. Response : The structure of monitoring businesses and the arrangements made with hospitals are not a factor in determining the inputs typical to a pa rticular service. Since this service is furnished in a facility, we have not included direct PE inputs for this service. We continue to believe that this service should be priced without direct PE inputs because when a service is furnished in the facility setting, the equipment, supplies, and labor costs of the service are considered in the calculation of Medicare payments made to the facility through other Medicare payment systems. After consideration of comments received, we are finalizing the CY 2013 interim final di rect PE inputs for 95940 and G0453 as established. (24) Neurology and Neuromuscular Procedures: Sleep Medicine Testing (CPT Codes 95782, 95783)

### CMS-1600-FC 305

In establishing interim final direct PE inputs for CY 2013, we refined the AMA RUC’s recommendation for CPT codes 95782 (Polysomnography, younger than 6 years, 4 or more) and 95783 (Polysomnography, younger than 6 years, w/cpap) by reducing time associated with “Measure and mark head and face. Apply and secure electrodes to head and face. Check impedances. Reapply electrodes as needed” and “apply recording devices” and removing equipment item “crib” for use in these services. We stated that we did not believe a crib would typica lly be used in this service, and we incorporated the bedroom furniture including a hospital bed and a reclining chair as typical equipment for this service.

Comment : Commenters disagreed, stating that it takes a dditional time to perform these clinical labor tasks for a child, and that we should assign 30 minutes to the “measure and mark head and face” task and 25 minutes to the “apply recording devices” task . Commenters also indicated that the crib is used in the typical case, while the parent uses the hospital bed to remain close to the child. We also received a paid invoice for the equipment item “crib.” Response : After additional clinical review, we agre e with commenters’ explanation that the additional clinical labor minutes are required when furnishing these services to children. Therefore, we are allocating an additional 5 minutes for each of these tasks, so that 25 minutes are allocated based on the

clinical labor task called “Measure and mark head and face. Apply and secure electrodes to head and face. Check impedances. Reapply electrodes as need ed” and 20 minutes are allocated for the task “apply recording devices.” Based on the information provided by commenters, we agree that the equipment item

“crib” should be included for CPT codes 95782 and 9 5783. We are pricing the equipment item “crib” at $3,900 based on the invoice received. After considera tion of the comments received, we are finalizing the CY 2013 interim final direct PE inputs for 95782 and 95783 as established with the additional refinement of adjusting the clinical labor time and incorporating the “crib” discussed above. (25) Neurology and Neuromuscular Procedures: Electromyography and Nerve Conduction Tests (CPT codes 95907, 95908, 95909, 95910, 95911, 95912, 95913, and 95861)

### CMS-1600-FC 306

In establishing interim final direct PE inputs for CY 2013, we refined the AMA RUC’s recommendation for CPT code 95861 by adjusting the tim e for the clinical labor activity “assist physician in performing procedure” from 19 minutes to 29 minutes to conform to physician time.

Comment : Commenters brought to our attention that this refinement was inaccurate, in that the

AMA RUC recommendation included 29 minutes for this labor activity. Response : We agree with commenters that this refi nement was inaccurate and acknowledge the administrative discrepancy in the refinement table. We note that this had no impact on payment rates, since there was no corresponding di screpancy in the direct PE input database. After considering comments received, we are finalizing the CY 2013 in terim final direct PE inputs for CPT code 95861 as

established. We also refined the AMA RUC’s recommendation for CPT codes 95907, 95908, 95909, 95910, 95911, 95912, and 95913 by substituting non-sterile gauze for steril e gauze, and removing surgical tape and electrode gel.

Comment : Commenters indicated that sterile gauze is required because the skin is cleansed before the procedure with vigorous scrubbing that of ten can produce minor bleeding, and that tape is required because the electrodes may not stick well when testing patients who have used lotions or creams prior to testing. Finally, the electrode gel is requi red to maximize conductivity, especially in patients who have used lotions or creams prior to testing. Response : We agree with commenters that the sterile gauze and tape should be included for this service. However, since the disposable electrode pack includes pre-gelled electrodes, we do not believe it is typical that electrode gel is also used in this pr ocedure. After consideration of public comments, we are finalizing the CY 2013 interim final direct practice expense inputs for CPT codes 95907 – 95913 as established, with the additional refinement of including the sterile gauze and tape. (26) Neurology and Neuromuscular Procedures: Autonomic Function Testing (CPT Codes 95921, 95922, 95923, and 95924)

### CMS-1600-FC 307

In establishing interim final direct PE inputs for CY 2013, we refined the AMA RUC’s recommendation for CPT codes 95921 and 95922 by re moving the preservice clinical labor tasks, and adjusting the monitoring time following the procedure from 5 to 2 minutes for 95921, 95922, 95923, and

95924.

Comment : Commenters stated that the patient requires assistance following the tests; therefore, additional time for monitoring the patient is necessary a nd should be added to the number of clinical labor minutes in the service period. Response : CMS clinical staff reviewed the information presented by commenters and found no evidence that 2 minutes did not represent the typical resources involved in furnishing the service for CPT codes 95921, 95922, 95923, and 95924. In refining CPT codes 95921, 95922, 95923, and 9 5924, we refined the equipment time to reflect the typical use exclusive to the patient.

Comment : Commenters stated that extra time was requi red for the equipment so that the patient can lie still after the procedure to en sure that there are not negative side effects due to fluctuations in blood pressure. Response : We agree with commenters’ justification for allocating additional equipment minutes to account for the time that the patient is laying still after the procedure. In refining CPT code 95923, we refined the c linical labor activity “assist physician” to 45

minutes.

Comment : Commenters stated that an additional 10 minutes of “assist physician” time was needed to assist the patient out of the machine and into the shower, since patients are extremely sweaty after the procedure. Response : Assisting patients following the procedure is not part of the “assist physician” labor activity. Since this clinical labor activity was not specified in the AMA RUC recommendation, we do not believe this activity typically takes additional time over that already allotted to the procedure. After

### CMS-1600-FC 308

considering public comments received, we are finalizi ng the CY 2013 interim final direct practice expense inputs for CPT codes 95921 – 95924 as established.

(27) Special Dermatological Procedures (CPT Codes 96920, 96921, 96922) In establishing interim final direct PE inputs for CY 2013, we refined the AMA RUC’s recommendation for CPT codes 96920, 96921, and 96922 by decreasing the time allocated to clinical labor activity “monitor patient following service/check tubes, monitors, drains” from 3 minutes to 1 minutes, and clinical labor activity “clean room/equi pment by physician staff” from 3 minutes to 2

minutes.

Comment : Commenters objected to CMS’s refinement of clinical labor tasks below the standard

number of minutes allocated for these tasks. Response : We agree with commenters that the standard number of AMA RUC-recommended

minutes should be allocated for these tasks. After considering public comments received, we are finalizing the CY 2013 interim final direct practice expense inputs for CPT codes 96920, 96921, and 96922 with the additional refinement of adjusting the times allocated for the clinical labor activities noted

above. (28) Psychiatry (CPT codes 90791, 90832, 90834, and 90837)

As we addressed in the CY 2013 PFS final rule (77 FR 69075), the AMA RUC submitted direct PE input recommendations in the revised set of c odes that describe psychotherapy services. These recommendations included significant reductions to th e direct PE inputs associated with the predecessor codes. For most of the new codes, we accepted these recommended reductions in direct practice expense. This was consistent with our gene ral approach of maintaining the existing values for these services given that many practitioners who furnished these services pr ior to CY 2013 would repo rt concurrent medical evaluation and management services (which have practi ce expense values that will offset the differences in total PE values between the new and old psychothera py codes). However, for practitioners who do not furnish medical E/M services, there were no corres ponding PE value increases to offset the recommended reductions. Therefore, instead of accepting the recomme nded direct PE inputs for the new CPT codes that

### CMS-1600-FC 309

describe services primarily furnished by practitioners who do not also report medical E/M services, for CY 2013, we crosswalked the 2012 PE RVUs from the predecessor codes. This crosswalk used the CY 2012 year fully-implemented PE RVUs establishe d for CPT codes 90791 (Psychiatric diagnostic evaluation), 90832 (Psychotherapy, 30 minutes with patient and/or family member), 90834 (Psychotherapy, 45 minutes with patient and/or fa mily member), and 90837 (Psychotherapy, 60 minutes with patient and/or family member).

Comment : Several commenters pointed out that by crosswalking the PE RVUs from predecessor codes, CMS created a rank order anomaly for CPT c odes 90791 (Psychiatric diagnostic evaluation) and 90792 (Psychiatric diagnostic eval uation with medical services). These commenters urged CMS to issue a technical correction for CY 2013 and accept th e AMA-RUC recommended inputs in developing PE

RVUs for these services for CY 2014. Response : We appreciate the commenters’ concerns regarding rank order anomalies for these services. However, as we explained in establishing th e interim final values for CY 2013, we believed that it was important to maintain approximate overall va lue for the family of services for the specialties involved, pending valuation of the whole set of codes for CY 2014. Now that we have considered the full family of codes for CY 2014 including the additiona l work RVUs, we agree with the commenters and

believe that the AMA RUC- recommended direct PE inputs for the whole family of codes can be implemented. Given the significant change in PE RV Us and in the context of the whole family of services, the direct PE inputs for these services will be interim final and subject to comment for CY 2014.

Comment : In a comment to the CY 2014 proposed PFS rule, one commenter argued that the

crosswalked PE RVUs for these services should be main tained due to the negative impact of the PE methodology on certain specialties, especi ally clinical psychologists. This commenter also suggested that

the reductions in PE RVUs that would result fro m implementing the AMA RUC recommended direct PE inputs for CY 2014 would fully offset an y increases in work RVUs for these services. Response : We do not agree that the reductions in PE RVUs that result from the AMA RUCrecommended inputs fully offset the increases in overall payment for these services that results from

### CMS-1600-FC 310

CMS’ adoption of the AMA RUC-recommended work R VUs for most of the codes in this family. However, we will consider the commenter’s concer ns regarding the effect of the PE methodology for specialties like clinical psychologists for future rulemaking. (29) Transitional Care Manageme nt Services (CPT Codes 99495, 99496) In establishing interim final direct PE inputs for CY 2013, we refined the AMA RUC recommendation by incorporating the clinical labor inputs for dedicated non-face-to-face care management tasks as facility inputs in addition to increasing clinical labor minutes for 99496.

Comment : The AMA RUC disagreed with CMS’s refine ment to include clinical labor minutes in the facility setting based on the assertion that the no n-face-to-face care management tasks are critical to the codes and cannot be separated from the care coordination delivered by the clinical staff in the non-facility setting. The AMA RUC also suggested that several medical specialty societies also disagreed with the re finement to include clinical labor minutes in the facility setting, while one specialty society agreed with our refinement. Response : After considering the rationale of the AMA RUC, we agree that only non-facility direct PE inputs should be included for these services. Therefore, we are finalizing the CY 2013 interim final direct PE inputs for 99495 and 99496 as establishe d with the additional refinement of removing the facility direct PE inputs. c. Finalizing CY 2013 Interim and Proposed Malpractice Crosswalks for CY 2014 In accordance with our malpractice methodology, we adjusted the malpract ice RVUs for the CY

2013 new/revised codes for the difference in work RVUs (or, if greater, the clinical labor portion of the PE RVUs) between the source codes and the new/revised codes to reflect the specific risk-of-service for the new/revised codes. The interim final malpractic e crosswalks were listed in Table 75 of the CY 2013 PFS final rule with comment period.

We received no comments on the CY 2013 interim fi nal malpractice crosswalks and are finalizing them without modification for CY 2014. The malp ractices RVUs for these services are reflected in

Addendum B of this CY 2014 PFS fina l rule with comment period.

### CMS-1600-FC 311

Consistent with past practice when the MEI has been rebased or revised we proposed to make adjustments to ensure that estimates of the aggregate CY 2014 PFS payments for work, PE and malpractice are in proportion to the weights for these categories in the revised MEI. As discussed in the II.A., the MEI is being revised for CY 2014, the PE a nd malpractice RVUs, and the CF are being adjusted accordingly. For more information on this, see secti on II.B. We received no comments specifically on the adjustment to malpractice RVUs. d. Other New, Revised or Potentially Misval ued Codes with CY 2013 Interim Final RVUs Not Specifically Discussed in the CY 2014 Final Rule with Comment Period For all other new, revised, or potentially misvalue d codes with CY 2013 interim final RVUs that are not specifically discussed in this CY 2014 PFS fina l rule with comment period, we are finalizing for CY 2014, without modification, the CY 2013 interim final or CY 2014 proposed work RVUs, malpractice crosswalks, and direct PE inputs. Unless otherwi se indicated, we agreed with the time values recommended by the AMA RUC or HCPAC for all cod es addressed in this section. The time values for

all codes are listed in a file called “CY 2014 PFS Ph ysician Time,” available on the CMS website under

downloads for the CY 2014 PFS fina l rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Ser vice-Payment/PhysicianFeeSched/PFS-FederalRegulation-Notices.html

.

### CMS-1600-FC 312

3. Establishing CY 2014 Interim Final RVUs a. Establishing CY 2014 Interim Final Work RVUs

Table 27 contains the CY 2014 interim final work RVUs for all codes for which we received

AMA RUC recommendations for CY 2014 and new G- codes created for CY 2014. These values are subject to public comment in this final rule with comment period. Codes for which work RVUs are not applicable have the appropriate PFS procedure status indicator in the relevant column. A description of all PFS procedure status indicators can be found in Addendum A. The column labeled “CMS Time

Refinement” indicates for each code whether we re fined the time values recommended by the AMA RUC

or HCPAC. The RVUs and other payment information for all CY 2014 payable codes are available in

Addendum B. The RVUs and other payment information regarding all codes subject to public comment in this final rule with comment period are availabl e in Addendum C. All addenda are available on the CMS website under downloads for the CY 2014 PFS final rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Ser vice-Payment/PhysicianFeeSched/PFS-FederalRegulation-Notices.html . The time values for all CY 2014 codes are listed in a file called “CY 2014 PFS Physician Time,” available on the CMS website unde r downloads for the CY 2014 PFS final rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html

. TABLE 27: Interim Final Work RVUs for New/Revised/Potentially Misvalued Codes

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement

10030 Image-guided fluid collection drainage by catheter (eg, abscess, hematoma, seroma, lymphocele, cyst), soft tissue (eg, extremity, abdominal wall, neck), percutaneous New 3.00 3.00 No

17000 Destruction (eg, laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), 0.65 0.61 0.61 No

### CMS-1600-FC 313

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement premalignant lesions (eg, actinic keratoses); first lesion

17003 Destruction (eg, laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), premalignant lesions (eg, actinic keratoses); second through 14 lesions, each (list separately in addition to code for first lesion) 0.07 0.04 0.04 No

17004 Destruction (eg, laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), premalignant lesions (eg, actinic keratoses), 15 or more lesions 1.85 1.37 1.37 No

17311 Mohs micrographic technique, including removal of all gross tumor, surgical excision of tissue specimens, mapping, color coding of specimens, microscopic examination of specimens by the surgeon, and histopathologic preparation including routine stain(s) (eg, hematoxylin and eosin, toluidine blue), head, neck, hands, feet, genitalia, or any location with surgery directly involving muscle, cartilage, bone, tendon, major nerves, or vessels; first stage, up to 5 tissue blocks 6.20 6.20 6.20 No

17312 Mohs micrographic technique, including removal of all gross tumor, surgical excision of tissue specimens, mapping, color coding of specimens, microscopic examination of specimens by the surgeon, and histopathologic preparation including routine stain(s) (eg, hematoxylin and eosin, toluidine blue), head, neck, hands, feet, genitalia, or any location with surgery directly involving muscle, cartilage, bone, tendon, major nerves, or vessels; each additional stage after the first stage, up to 5 tissue blocks (list separately in addition to code for primary procedure) 3.30 3.30 3.30 No

17313 Mohs micrographic technique, including removal of all gross tumor, surgical 5.56 5.56 5.56 No

### CMS-1600-FC 314

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement excision of tissue specimens, mapping, color coding of specimens, microscopic examination of specimens by the surgeon, and histopathologic preparation including routine stain(s) (eg, hematoxylin and eosin, toluidine blue), of the trunk, arms, or legs; first stage, up to 5 tissue blocks

17314 Mohs micrographic technique, including removal of all gross tumor, surgical excision of tissue specimens, mapping, color coding of specimens, microscopic examination of specimens by the surgeon, and histopathologic preparation including routine stain(s) (eg, hematoxylin and eosin, toluidine blue), of the trunk, arms, or legs; each additional stage after the first stage, up to 5 tissue blocks (list separately in addition to code for primary procedure) 3.06 3.06 3.06 No

17315 Mohs micrographic technique, including removal of all gross tumor, surgical excision of tissue specimens, mapping, color coding of specimens, microscopic examination of specimens by the surgeon, and histopathologic preparation including routine stain(s) (eg, hematoxylin and eosin, toluidine blue), each additional block after the first 5 tissue blocks, any stage (list separately in addition to code for primary procedure) 0.87 0.87 0.87 No

19081 Biopsy, breast, with placement of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; first lesion, including stereotactic guidance New 3.29 3.29 No

19082 Biopsy, breast, with placement of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; each additional lesion, including stereotactic guidance (list separately in addition to code for primary New 1.65 1.65 No

### CMS-1600-FC 315

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement procedure)

19083 Biopsy, breast, with placement of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; first lesion, including ultrasound guidance New 3.10 3.10 No

19084 Biopsy, breast, with placement of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; each additional lesion, including ultrasound guidance (list separately in addition to code for primary procedure) New 1.55 1.55 No

19085 Biopsy, breast, with placement of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; first lesion, including magnetic resonance guidance New 3.64 3.64 No

19086 Biopsy, breast, with placement of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; each additional lesion, including magnetic resonance guidance (list separately in addition to code for primary procedure) New 1.82 1.82 No

19281 Placement of breast localization device(s) (eg, clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; first lesion, including mammographic guidance New 2.00 2.00 No

19282 Placement of breast localization device(s) (eg, clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; each additional lesion, including mammographic guidance (list separately in addition to code for primary procedure) New 1.00 1.00 No

19283 Placement of breast localization device(s) (eg, clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; first New 2.00 2.00 No

### CMS-1600-FC 316

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement lesion, including stereotactic guidance

19284 Placement of breast localization device(s) (eg, clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; each additional lesion, including stereotactic guidance (list separately in addition to code for primary procedure) New 1.00 1.00 No

19285 Placement of breast localization device(s) (eg, clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; first lesion, including ultrasound guidance New 1.70 1.70 No

19286 Placement of breast localization device(s) (eg, clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; each additional lesion, including ultrasound guidance (list separately in addition to code for primary procedure) New 0.85 0.85 Yes

19287 Placement of breast localization device(s) (eg clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; first lesion, including magnetic resonance guidance New 3.02 2.55 No

19288 Placement of breast localization device(s) (eg clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; each additional lesion, including magnetic resonance guidance (list separately in addition to code for primary procedure) New 1.51 1.28 No

23333 Removal of foreign body, shoulder; deep (subfascial or intramuscular) New 6.00 6.00 No

23334 Removal of prosthesis, includes debridement and synovectomy when performed; humeral or glenoid component New 18.89 15.50 No

23335 Removal of prosthesis, includes debridement and synovectomy when performed; humeral and glenoid components (eg, total shoulder) New 22.13 19.00 No

24164 Removal of prosthesis, includes debridement and synovectomy when performed; radial head 6.43 10.00 10.00 No

### CMS-1600-FC 317

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement

27130 Arthroplasty, aceta bular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft 21.79 19.60 20.72 Yes

27236 Open treatment of femoral fracture, proximal end, neck, internal fixation or prosthetic replacement 17.61 17.61 17.61 Yes

27446 Arthroplasty, knee, condyle and plateau; medial or lateral compartment 16.38 17.48 17.48 No

27447 Arthroplasty, knee, condyle and plateau; medial and lateral compartments with or without patella resurfacing (total knee arthroplasty) 23.25 19.60 20.72 Yes

31237 Nasal/sinus endoscopy, surgical; with biopsy, polypectomy or debridement (separate procedure) 2.98 2.60 2.60 No

31238 Nasal/sinus endoscopy, surgical; with control of nasal hemorrhage 3.26 2.74 2.74 No

31239 Nasal/sinus endoscopy, surgical; with dacryocystorhinostomy 9.33 9.04 9.04 No

31240 Nasal/sinus endoscopy, surgical; with concha bullosa resection 2.61 2.61 2.61 No

33282 Implantation of patient-activated cardiac event recorder 4.80 3.50 3.50 No

33284 Removal of an implantable, patientactivated cardiac event recorder 3.14 3.00 3.00 No

33366 Transcatheter aortic valve replacement (tavr/tavi) with prosthetic valve; transapical exposure (eg, left thoracotomy) New 40.00 35.88 No

34841 Endovascular repair of visceral aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) by deployment of a fenestrated visceral aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including one visceral artery endoprosthesis (superior mesenteric, New C C N/A

### CMS-1600-FC 318

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement celiac or renal artery)

34842 Endovascular repair of visceral aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) by deployment of a fenestrated visceral aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including two visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s]) New C C N/A

34843 Endovascular repair of visceral aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) by deployment of a fenestrated visceral aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including three visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s]) New C C N/A

34844 Endovascular repair of visceral aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) by deployment of a fenestrated visceral aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including four or more visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s]) New C C N/A

### CMS-1600-FC 319

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement

34845 Endovascular repair of visceral aorta and infrarenal abdominal aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) with a fenestrated visceral aortic endograft and concomitant unibody or modular infrarenal aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including one visceral artery endoprosthesis (superior mesenteric, celiac or renal artery) New C C N/A

34846 Endovascular repair of visceral aorta and infrarenal abdominal aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) with a fenestrated visceral aortic endograft and concomitant unibody or modular infrarenal aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including two visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s]) New C C N/A

34847 Endovascular repair of visceral aorta and infrarenal abdominal aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) with a fenestrated visceral aortic endograft and concomitant unibody or modular infrarenal aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including three visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s]) New C C N/A

34848 Endovascular repair of visceral aorta and infrarenal abdominal aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) with a fenestrated visceral New C C N/A

### CMS-1600-FC 320

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement aortic endograft and concomitant unibody or modular infrarenal aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including four or more visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s])

35301 Thromboendarterectomy, including patch graft, if performed; carotid, vertebral, subclavian, by neck incision 19.61 21.16 21.16 No

36245 Selective catheter placement, arterial system; each first order abdominal, pelvic, or lower extremity artery branch, within a vascular family 4.67 4.90 4.90 No

37217 Transcatheter placement of an intravascular sten t(s), intrathoracic common carotid artery or innominate artery by retrograde treatment, via open ipsilateral cervical carotid artery exposure, including angioplasty, when performed, and radiological supervision and interpretation New 22.00 20.38 No

37236 Transcatheter placement of an intravascular stent(s) (except lower extremity, cervical carotid, ex tracranial vertebral or intrathoracic carotid, intracranial, or coronary), open or percutaneous, including radiological supervision and interpretation and including all angioplasty within the same vessel, when performed; initial artery New 9.00 9.00 No

37237 Transcatheter placement of an intravascular stent(s) (except lower extremity, cervical carotid, ex tracranial vertebral or intrathoracic carotid, intracranial, or coronary), open or percutaneous, including radiological supervision and interpretation and including all angioplasty within the same vessel, when performed; each additional artery (list separately in addition to code for primary procedure) New 4.25 4.25 No

### CMS-1600-FC 321

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement

37238 Transcatheter placement of an intravascular stent(s), open or percutaneous, including radiological supervision and interpretation and including angioplasty within the same vessel, when performed; initial vein New 6.29 6.29 No

37239 Transcatheter placement of an intravascular stent(s), open or percutaneous, including radiological supervision and interpretation and including angioplasty within the same vessel, when performed; each additional vein (list separately in addition to code for primary procedure) New 3.34 2.97 No

37241 Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; venous, other than hemorrhage (eg, congenital or acquired venous malformations, venous and capillary hemangiomas, varices, varicoceles) New 9.00 9.00 No

37242 Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; arterial, other than hemorrhage or tumor (eg, congenital or acquired arterial malformations, arteriovenous malformations, arteriovenous fistulas, aneurysms, pseudoaneurysms) New 11.98 10.05 No

37243 Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for tumors, organ ischemia, or infarction New 14.00 11.99 No

37244 Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; New 14.00 14.00 No

### CMS-1600-FC 322

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement for arterial or venous hemorrhage or lymphatic extravasation

43191 Esophagoscopy, rigid, transoral; diagnostic, including collection of specimen(s) by brushing or washing when performed (separate procedure) New 2.78 2.00 No

43192 Esophagoscopy, rigid, transoral; with directed submucosal injection(s), any substance New 3.21 2.45 No

43193 Esophagoscopy, rigid, transoral; with biopsy, single or multiple New 3.36 3.00 No

43194 Esophagoscopy, rigid, transoral; with removal of foreign body New 3.99 3.00 No

43195 Esophagoscopy, rigid, transoral; with balloon dilation (less than 30 mm diameter) New 3.21 3.00 No

43196 Esophagoscopy, rigid, transoral; with insertion of guide wire followed by dilation over guide wire New 3.36 3.30 No

43197 Esophagoscopy, flexible, transnasal; diagnostic, includes collection of specimen(s) by brushing or washing when performed (separate procedure) New 1.59 1.48 Yes

43198 Esophagoscopy, flexible, transnasal; with biopsy, single or multiple New 1.89 1.78 Yes

43200 Esophagoscopy, flexible, transoral; diagnostic, including collection of specimen(s) by brushing or washing, when performed (separate procedure) 1.59 1.59 1.50 No

43201 Esophagoscopy, flexible, transoral; with directed submucosal injection(s), any substance 2.09 1.90 1.80 No

43202 Esophagoscopy, flexible, transoral; with biopsy, single or multiple 1.89 1.89 1.80 No

43204 Esophagoscopy, flexible, transoral; with injection sclerosis of esophageal varices 3.76 2.89 2.40 No

43205 Esophagoscopy, flexible, transoral; with band ligation of esophageal varices 3.78 3.00 2.51 No

43211 Esophagoscopy, flexible, transoral; with endoscopic mucosal resection New 4.58 4.21 No

43212 Esophagoscopy, flexible, transoral; with placement of endoscopic stent (includes pre- and post-dilation and guide wire New 3.73 3.38 No

### CMS-1600-FC 323

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement passage, when performed)

43213 Esophagoscopy, flexible, transoral; with dilation of esophagus, by balloon or dilator, retrograde (includes fluoroscopic guidance, when performed) New 5.00 4.73 No

43214 Esophagoscopy, flexible, transoral; with dilation of esophagus with balloon (30 mm diameter or larger) (includes fluoroscopic guidance, when performed) New 3.78 3.38 No

43215 Esophagoscopy, flexible, transoral; with removal of foreign body 2.60 2.60 2.51 No

43216 Esophagoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by hot biopsy forceps or bipolar cautery 2.40 2.40 2.40 No

43217 Esophagoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique 2.90 2.90 2.90 No

43220 Esophagoscopy, flexible, transoral; with transendoscopic balloon dilation (less than 30 mm diameter) 2.10 2.10 2.10 No

43226 Esophagoscopy, flexible, transoral; with insertion of guide wire followed by passage of dilator(s) over guide wire 2.34 2.34 2.34 No

43227 Esophagoscopy, flexible, transoral; with control of bleeding, any method 3.59 3.26 2.99 No

43229 Esophagoscopy, flexible, transoral; with ablation of tumor(s), polyp(s), or other lesion(s) (includes pre- and post-dilation and guide wire passage, when performed) New 3.72 3.54 No

43231 Esophagoscopy, flexible, transoral; with endoscopic ultrasound examination 3.19 3.19 2.90 No

43232 Esophagoscopy, flexible, transoral; with transendoscopic ultrasound-guided intramural or transmural fine needle aspiration/biopsy(s) 4.47 3.83 3.54 No

43233 Esophagogastroduodenoscopy, flexible, transoral; with dilation of esophagus with balloon (30 mm diameter or larger) (includes fluoroscopic guidance, when performed) New 4.45 4.05 No

43235 Esophagogastroduodenoscopy, flexible, 2.39 2.26 2.17 No

### CMS-1600-FC 324

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement transoral; diagnostic, including collection of specimen(s) by brushing or washing, when performed (separate procedure)

43236 Esophagogastroduodenoscopy, flexible, transoral; with directed submucosal injection(s), any substance 2.92 2.57 2.47 No

43237 Esophagogastroduodenoscopy, flexible, transoral; with endoscopic ultrasound examination limited to the esophagus, stomach or duodenum, and adjacent structures 3.98 3.85 3.57 No

43238 Esophagogastroduodenoscopy, flexible, transoral; with transendoscopic ultrasound-guided intramural or transmural fine needle aspiration/biopsy(s), esophagus (includes endoscopic ultrasound examination limited to the esophagus, stomach or duodenum, and adjacent structures) 5.02 4.50 4.11 No

43239 Esophagogastroduodenoscopy, flexible, transoral; with biopsy, single or multiple 2.87 2.56 2.47 No

43240 Esophagogastroduodenoscopy, flexible, transoral; with transmural drainage of pseudocyst (includes placement of transmural drainage catheter[s]/stent[s], when performed, and endoscopic ultrasound, when performed) 6.85 7.25 7.25 No

43241 Esophagogastroduodenoscopy, flexible, transoral; with insertion of intraluminal tube or catheter 2.59 2.59 2.59 No

43242 Esophagogastroduodenoscopy, flexible, transoral; with transendoscopic ultrasound-guided intramural or transmural fine needle aspiration/biopsy(s) (includes endoscopic ultrasound examination of the esophagus, stomach, and either the duodenum or a surgically altered stomach where the jejunum is examined distal to the anastomosis) 7.30 5.39 4.68 No

43243 Esophagogastroduodenoscopy, flexible, transoral; with injection sclerosis of esophageal/gastric varices 4.56 4.37 4.37 No 43244 Esophagogastroduodenoscopy, flexible, 5.04 4.50 4.50 No

### CMS-1600-FC 325

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement transoral; with band ligation of esophageal/gastric varices

43245 Esophagogastroduodenoscopy, flexible, transoral; with dilation of gastric/duodenal stricture(s) (eg, balloon, bougie) 3.18 3.18 3.18 No

43246 Esophagogastroduodenoscopy, flexible, transoral; with directed placement of percutaneous gastrostomy tube 4.32 4.32 3.66 No

43247 Esophagogastroduodenoscopy, flexible, transoral; with removal of foreign body 3.38 3.27 3.18 No

43248 Esophagogastroduodenoscopy, flexible, transoral; with insertion of guide wire followed by passage of dilator(s) through esophagus over guide wire 3.15 3.01 3.01 No

43249 Esophagogastroduodenoscopy, flexible, transoral; with transendoscopic balloon dilation of esophagus (less than 30 mm diameter) 2.90 2.77 2.77 No

43250 Esophagogastroduodenoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by hot biopsy forceps or bipolar cautery 3.20 3.07 3.07 No

43251 Esophagogastroduodenoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique 3.69 3.57 3.57 No

43253 Esophagogastroduodenoscopy, flexible, transoral; with transendoscopic ultrasound-guided transmural injection of diagnostic or therapeutic substance(s) (eg, anesthetic, neurolytic agent) or fiducial marker(s) (includes endoscopic ultrasound examination of the esophagus, stomach, and either the duodenum or a surgically altered stomach where the jejunum is examined distal to the anastomosis) New 5.39 4.68 No

43254 Esophagogastroduodenoscopy, flexible, transoral; with endoscopic mucosal resection New 5.25 4.88 No

43255 Esophagogastroduodenoscopy, flexible, transoral; with control of bleeding, any method 4.81 4.20 3.66 No

### CMS-1600-FC 326

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement

43257 Esophagogastroduodenoscopy, flexible, transoral; with delivery of thermal energy to the muscle of lower esophageal sphincter and/or gastric cardia, for treatment of gastroesophageal reflux disease 5.50 4.25 4.11 No

43259 Esophagogastroduodenoscopy, flexible, transoral; with endoscopic ultrasound examination, including the esophagus, stomach, and either the duodenum or a surgically altered stomach where the jejunum is examined distal to the anastomosis 5.19 4.74 4.14 No

43260 Endoscopic retrograde cholangiopancreatography (ercp); diagnostic, including collection of specimen(s) by brushing or washing, when performed (separate procedure) 5.95 5.95 5.95 No

43261 Endoscopic retrograde cholangiopancreatography (ercp); with biopsy, single or multiple 6.26 6.25 6.25 No

43262 Endoscopic retrograde cholangiopancreatography (ercp); with sphincterotomy/papillotomy 7.38 6.60 6.60 No

43263 Endoscopic retrograde cholangiopancreatography (ercp); with pressure measurement of sphincter of oddi 7.28 7.28 6.60 No

43264 Endoscopic retrograde cholangiopancreatography (ercp); with removal of calculi/debris from biliary/pancreatic duct(s) 8.89 6.73 6.73 No

43265 Endoscopic retrograde cholangiopancreatography (ercp); with destruction of calculi, any method (eg, mechanical, electrohy draulic, lithotripsy) 10.00 8.03 8.03 No

43266 Esophagogastroduodenoscopy, flexible, transoral; with placem ent of endoscopic stent (includes pre- and post-dilation and guide wire passage, when performed) New 4.40 4.05 No

### CMS-1600-FC 327

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement

43270 Esophagogastroduodenoscopy, flexible, transoral; with ablation of tumor(s),polyp(s), or other lesion(s) (includes preand post-dilation and guide wire passage, when performed) New 4.39 4.21 No

43273 Endoscopic cannulation of papilla with direct visualization of pancreatic/common bile duct(s) (list separately in addition to code(s) for primary procedure) 2.24 2.24 2.24 No

43274 Endoscopic retrograde cholangiopancreatography (ercp); with placement of endoscopic stent into biliary or pancreatic duct, including pre- and post-dilation and guide wire passage, when performed, including sphincterotomy, when performed, each stent New 8.74 8.48 No

43275 Endoscopic retrograde cholangiopancreatography (ercp); with removal of foreign body(s) or stent(s) from biliary/pancreatic duct(s) New 6.96 6.96 No

43276 Endoscopic retrograde cholangiopancreatography (ercp); with removal and exchange of stent(s), biliary or pancreatic duct, including pre- and post-dilation and guide wire passage, when performed, including sphincterotomy, when performed, each stent exchanged New 9.10 8.84 No

43277 Endoscopic retrograde cholangiopancreatography (ercp); with trans-endoscopic balloon dilation of biliary/pancreatic duct(s) or of ampulla (sphincteroplasty), including sphincterotomy, when performed, each duct New 7.11 7.00 No

43278 Endoscopic retrograde cholangiopancreatography (ercp); with ablation of tumor(s), polyp(s), or other lesion(s), including pre- and post-dilation and guide wire passage, when performed New 8.08 7.99 No

43450 Dilation of esophagus, by unguided sound or bougie, single or multiple 1.38 1.38 1.38 No

### CMS-1600-FC 328

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement

passes 43453 Dilation of esophagus, over guide wire 1.51 1.51 1.51 No

49405 Image-guided fluid collection drainage by catheter (eg, abscess, hematoma, seroma, lymphocele, cy st); visceral (eg, kidney, liver, spleen, lung/mediastinum), percutaneous New 4.25 4.25 No

49406 Image-guided fluid collection drainage by catheter (eg, abscess, hematoma, seroma, lymphocele, cy st); peritoneal or retroperitoneal, percutaneous New 4.25 4.25 No

49407 Image-guided fluid collection drainage by catheter (eg, abscess, hematoma, seroma, lymphocele, cy st); peritoneal or retroperitoneal, transvag inal or transrectal New 4.50 4.50 No

50360 Renal allotransplantation, implantation of graft; without recipient nephrectomy 40.90 40.90 39.88 No

52332 Cystourethroscopy, with insertion of indwelling ureteral stent (eg, gibbons or double-j type) 2.82 2.82 2.82 No

52356 Cystourethroscopy, with ureteroscopy and/or pyeloscopy; with lithotripsy including insertion of indwelling ureteral stent (eg, gibbons or double-j type) New 8.00 8.00 No

62310 Injection(s), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; cervical or thoracic 1.91 1.68 1.18 No

62311 Injection(s), of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, includes contrast for localization when performed, epidural or subarachnoid; lumbar or sacral (caudal) 1.54 1.54 1.17 No

62318 Injection(s), including indwelling catheter placement, co ntinuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (including 2.04 2.04 1.54 No

### CMS-1600-FC 329

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, includes contrast for localization when performed, epidural or subarachnoid; cervical or thoracic

62319 Injection(s), including indwelling catheter placement, co ntinuous infusion or intermittent bolus, of diagnostic or therapeutic substance(s) (including anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, includes contrast for localization when performed, epidural or subarachnoid; lumbar or sacral (caudal) 1.87 1.87 1.50 No

63047 Laminectomy, facetectomy and foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [eg, spinal or lateral recess stenosis]), single vertebral segment; lumbar 15.37 15.37 15.37 No

63048 Laminectomy, facetectomy and foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [eg, spinal or lateral recess stenosis]), single vertebral segment; each additional segment, cervical, thoracic, or lumbar (list separately in addition to code for primary procedure) 3.47 3.47 3.47 No

64616 Chemodenervation of muscle(s); neck muscle(s), excluding muscles of the larynx, unilateral (eg, for cervical dystonia, spasmodic torticollis) New 1.79 1.53 No

64617 Chemodenervation of muscle(s); larynx, unilateral, percutaneous (eg, for spasmodic dysphonia), includes guidance by needle electromyography, when performed New 2.06 1.90 No

64642 Chemodenervation of one extremity; 1-4 muscle(s) New 1.65 1.65 No

64643 Chemodenervation of one extremity; each additional extremity, 1-4 muscle(s) (list separately in addition to code for primary procedure) New 1.32 1.22 No

### CMS-1600-FC 330

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement

64644 Chemodenervation of one extremity; 5 or more muscle(s) New 1.82 1.82 No

64645 Chemodenervation of one extremity; each additional extremity, 5 or more muscle(s) (list separately in addition to code for primary procedure) New 1.52 1.39 No

64646 Chemodenervation of trunk muscle(s); 1- 5 muscle(s) New 1.80 1.80 No

64647 Chemodenervation of trunk muscle(s); 6 or more muscle(s) New 2.11 2.11 No

66183 Insertion of anterior segment aqueous drainage device, without extraocular reservoir, external approach New 13.20 13.20 No 67914 Repair of ectropion; suture 3.75 3.75 3.75 No 67915 Repair of ectropion; thermocauterization 3.26 2.03 2.03 No 67916 Repair of ectropion; excision tarsal wedge 5.48 5.48 5.48 No

67917 Repair of ectropion; extensive (eg, tarsal strip operations) 6.19 5.93 5.93 No 67921 Repair of entropion; suture 3.47 3.47 3.47 No 67922 Repair of entropion; thermocauterization 3.14 2.03 2.03 No 67923 Repair of entropion; excision tarsal wedge 6.05 5.48 5.48 No

67924 Repair of entropion; extensive (eg, tarsal strip or capsulopalpebral fascia repairs operation) 5.93 5.93 5.93 No

69210 Removal impacted cerumen requiring instrumentation, unilateral 0.61 0.58 0.61 No

70450 Computed tomography, head or brain; without contrast material 0.85 0.85 0.85 No

70460 Computed tomography, head or brain; with contrast material(s) 1.13 1.13 1.13 No

70551 Magnetic resonance (eg, proton) imaging, brain (including brain stem); without contrast material 1.48 1.48 1.48 No

70552 Magnetic resonance (eg, proton) imaging, brain (including brain stem); with contrast material(s) 1.78 1.78 1.78 No

70553 Magnetic resonance (eg, proton) imaging, brain (including brain stem); without contrast material, followed by contrast material(s) and further sequences 2.36 2.36 2.29 No

72141 Magnetic resonance (eg, proton) imaging, spinal canal and contents, cervical; 1.60 1.48 1.48 No

### CMS-1600-FC 331

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement

without contrast material

72142 Magnetic resonance (eg, proton) imaging, spinal canal and contents, cervical; with contrast material(s) 1.92 1.78 1.78 No

72146 Magnetic resonance (eg, proton) imaging, spinal canal and contents, thoracic; without contrast material 1.60 1.48 1.48 No

72147 Magnetic resonance (eg, proton) imaging, spinal canal and contents, thoracic; with contrast material(s) 1.92 1.78 1.78 No

72148 Magnetic resonance (eg, proton) imaging, spinal canal and contents, lumbar; without contrast material 1.48 1.48 1.48 No

72149 Magnetic resonance (eg, proton) imaging, spinal canal and contents, lumbar; with contrast material(s) 1.78 1.78 1.78 No

72156 Magnetic resonance (eg, proton) imaging, spinal canal and contents, without contrast material, followed by contrast material(s) and further sequences; cervical 2.57 2.29 2.29 No

72157 Magnetic resonance (eg, proton) imaging, spinal canal and contents, without contrast material, followed by contrast material(s) and further sequences; thoracic 2.57 2.29 2.29 No

72158 Magnetic resonance (eg, proton) imaging, spinal canal and contents, without contrast material, followed by contrast material(s) and further sequences; lumbar 2.36 2.29 2.29 No

77280 Therapeutic radiology simulation-aided field setting; simple 0.70 0.70 0.70 No

77285 Therapeutic radiology simulation-aided field setting; intermediate 1.05 1.05 1.05 No

77290 Therapeutic radiology simulation-aided field setting; complex 1.56 1.56 1.56 No

77293 Respiratory motion management simulation (list separately in addition to code for primary procedure) New 2.00 2.00 No

77295 3-dimensional radiotherapy plan, including dose-volume histograms 4.56 4.29 4.29 No

81161 Dmd (dystrophin) (eg, duchenne/becker muscular dystrophy) deletion analysis, and duplication analysis, if performed New 1.85 X N/A

### CMS-1600-FC 332

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement

88112 Cytopathology, selective cellular enhancement technique with interpretation (eg, liquid based slide preparation method), except cervical or vaginal 1.18 0.56 0.56 No

88342 Immunohistochemistry or immunocytochemistry, each separately identifiable antibody per block, cytologic preparation, or hematologic smear; first separately identifiable antibody per slide 0.85 0.60 I N/A

88343 Immunohistochemistry or immunocytochemistry, each separately identifiable antibody per block, cytologic preparation, or hematologic smear; each additional separately identifiable antibody per slide (list separately in addition to code for primary procedure) New 0.24 I N/A

92521 Evaluation of speech fluency (eg, stuttering, cluttering) New 1.75 1.75 No

92522 Evaluation of speech sound production (eg, articulation, phonological process, apraxia, dysarthria); New 1.50 1.50 No

92523 Evaluation of speech sound production (eg, articulation, phonological process, apraxia, dysarthria); with evaluation of language comprehension and expression (eg, receptive and expressive language) New 3.36 3.00 No

92524 Behavioral and qualitative analysis of voice and resonance New 1.75 1.50 No

93000 Electrocardiogram, routine ecg with at least 12 leads; with interpretation and report 0.17 0.17 0.17 No

93010 Electrocardiogram, routine ecg with at least 12 leads; interpretation and report only 0.17 0.17 0.17 No

93582 Percutaneous transcatheter closure of patent ductus arteriosus New 14.00 12.56 No

93583 Percutaneous transcatheter septal reduction therapy (eg, alcohol septal ablation) including temporary pacemaker insertion when performed New 14.00 14.00 No

93880 Duplex scan of extracranial arteries; complete bilateral study 0.60 0.80 0.60 No

### CMS-1600-FC 333

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement

93882 Duplex scan of extracranial arteries; unilateral or limited study 0.40 0.50 0.40 No

95816 Electroencephalogram (eeg); including recording awake and drowsy 1.08 1.08 1.08 No

95819 Electroencephalogram (eeg); including recording awake and asleep 1.08 1.08 1.08 No

95822 Electroencephalogram ( eeg); recording in coma or sleep only 1.08 1.08 1.08 No

96365 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour 0.21 0.21 0.21 No

96366 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); each additional hour (list separately in addition to code for primary procedure) 0.18 0.18 0.18 No

96367 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); additional sequential infusion of a new drug/substance, up to 1 hour (list separately in addition to code for primary procedure) 0.19 0.19 0.19 No

96368 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); concurrent infusion (list separately in addition to code for primary procedure) 0.17 0.17 0.17 No

96413 Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug 0.28 0.28 0.28 No

96415 Chemotherapy administration, intravenous infusion technique; each additional hour (list separately in addition to code for prim ary procedure) 0.19 0.19 0.19 No

96417 Chemotherapy administration, intravenous infusion technique; each additional sequential infusion (different substance/drug), up to 1 hour (list separately in addition to code for primary procedure) 0.21 0.21 0.21 No

97610 Low frequency, non-contact, non-thermal ultrasound, including topical application(s), when performed, wound assessment, and instruction(s) for New C C N/A

### CMS-1600-FC 334

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement ongoing care, per day

98940 Chiropractic manipulative treatment (cmt); spinal, 1-2 regions 0.45 0.46 0.46 No

98941 Chiropractic manipulative treatment (cmt); spinal, 3-4 regions 0.65 0.71 0.71 No

98942 Chiropractic manipulative treatment (cmt); spinal, 5 regions 0.87 0.96 0.96 No

99446 Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional; 5-10 minutes of medical consultative discussion and review New 0.35 B No

99447 Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional; 11-20 minutes of medical consultative discussion and review New 0.70 B No

99448 Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional; 21-30 minutes of medical consultative discussion and review New 1.05 B No

99449 Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional; 31 minutes or more of medical consultative discussion and review New 1.40 B No

99481 Total body systemic hypothermia in a critically ill neonate per day (list separately in addition to code for primary New C C N/A

### CMS-1600-FC 335

HCPCS

Code Long Descriptor CY 2013 Work RVU AMA RUC/ HCPAC Recommended

Work RVU CY 2014 Work RVU CMS Time Refinement procedure)

99482 Selective head hypothermia in a critically ill neonate per day (list separately in addition to code for primary procedure) New C C N/A

G0461 Immunohistochemistry or immunocytochemistry, per specimen; first separately identifiable antibody New N/A 0.60 No

G0462 Immunohistochemistry or immunocytochemistry, per specimen; each additional separately identifiable antibody (List separately in addition to code for primary procedure). New N/A 0.24 No

As previously discussed in section III.E.2 of this final rule with comment period, each year, the AMA RUC and HCPAC, along with other public co mmenters, provide us with recommendations regarding physician work values for new, revised, and potentially misvalued CPT codes. This section

discusses codes for which the interim final work RVU or time values assigned for CY 2014 vary from those recommended by the AMA RUC. It also di scusses work RVU and time values for new and revised

HCPCS G-codes. i. Code Specific Issues (1) Breast Biopsy (CPT Codes 19081, 19082, 19083, 19084, 19085, 19086, 19281, 19282, 19283, 19284, 19285, 19286, 19287, and 19288)

The AMA RUC identified several breast interv ention codes as potentially misvalued using the codes reported together 75 percent or more scree n as potentially misvalued. For CY 2014, the CPT Editorial Panel created 14 new codes, CPT codes 19081through 19288, to d escribe breast biopsy and placement of breast localization devices. We are establishing the AMA RUC-recommended values as CY 2014 interim final values for all of the breast biopsy codes with the exception of C PT code 19287 and its add-on CPT code, 19288. We believe that the work RVU recommended by the AMA RUC for CPT code 19287 would create a rank

### CMS-1600-FC 336

order anomaly with other codes in the family. To avoid this anomaly, we are assigning a CY 2014 interim final work RVU of 2.55, which is between the 25th percentile and the median work RVU in the survey. In determining how to value this service, we examined the work RVU relationship among the breast biopsy codes as established by the AMA RUC and believed those to be correct. We used those relationships to establish the value for CPT code 19287. We believe that using this work value creates the appropriate relativity with other codes in the family. To value CPT code 19288, we followed the same procedure used by the AMA RUC in making its recommendation for the add-on codes, which was to valu e add-on services at 50 percent of the applicable base code value, resulting in a work RVU of 1.28 for CPT code 19288. We received public input suggesting that when one of these procedures is performed without mammography guidance, mammography is commonly pe rformed afterwards to confirm appropriate placement. We seek public input as to whether or not post-procedure mammography is commonly furnished with breast biopsy and marker placement, and if so, whether the services should be bundled together. Finally, we note that the physician intraservice ti me for CPT code 19286, which is an add-on code, is 19 minutes, which is higher than the 15 minutes of intraservice time for its base code, CPT code 19285. Therefore we are reducing the intraservice ti me for CPT code 19286 to the survey 25 th percentile value of

14 minutes. (2) Shoulder Prosthesis Removal (CPT Codes 23333, 23334, and 23335) Three new codes, CPT codes 23333, 23334 and 2333 5, were created to replace CPT codes 23331 (removal of foreign body, shoulder; deep (eg, Neer hemiarthroplasty removal)) and 23332 (removal of foreign body, shoulder; complicated (eg, total shoulder)). We are establishing a CY 2014 interim final work RVU of 6.00 for CPT code 23333, as recommended by the AMA RUC.

The AMA RUC recommended a work RVU of 18.89 for CPT code 23334 based on a crosswalk to the work value of CPT code 27269 (Open treatment of femoral fracture, proximal end, head, includes

### CMS-1600-FC 337

internal fixation, when performed). The code curre ntly reported for this service, CPT code 23331, has a work RVU of 7.63. Recognizing that more physic ian time is involved with CPT code 23334 than CPT code 23331 and that the technique for removal of prosth esis may have changed since its last valuation, we

still do not believe that the work has more than doubled for this service. Therefore, instead of assigning a work RVU of 18.89, we are assigning CPT 23334 a CY 2014 interim final work RVU of 15.50, based upon the 25 th percentile of the survey. We believe this mo re appropriately reflects the work required to

furnish this service. Similarly, we believe that the 25 th percentile of the survey also provides the appropriate work

RVU for CPT code 23335. The AMA RUC recommended a work RVU of 22.13 based on a crosswalk to

the CY 2013 interim final value of CPT code 23472 (Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (eg, total shoulder))). CPT code 23332 is currently billed for the work of new CPT code 23335 and has a work RVU of 12.37. Although the physician time for CPT code 23335 has increased from that of the predeces sor code, CPT code 22332, and the technique for removal of prosthesis may have changed, we do not believe that the work has almost doubled for this service. Therefore, we are assigning a work RVU of 19.00 based upon the 25th percentile work RVU in the survey. We believe this appropriately reflect s the work required to perform this service. (3) Hip and Knee Replacement (CPT Codes 27130, 27236, 27446 and 27447) CPT codes CY 27130, 27446 and 27447 were iden tified as potentially misvalued codes under the CMS high expenditure procedural code screen in the CY 2012 final rule with comment period. The AMA RUC reviewed the family of codes for hip and knee replacement (CPT codes 27130, 27236, 27446 and 27447) and provided us with recommendations for wo rk RVUs and physician time for these services for CY 2014. We are establishing the AMA RUC-recommended values of 17.61 and 17.48 a CY 2014 interim final work RVUs for CPT codes 27236 and 27446, respectively. For CPT codes 27130 and 27447, we are establishing work RVUs that vary from those recommended by the AMA RUC. In addition to the recommendation we received from the AMA RUC,

we received alternative recommenda tions and input regarding appropriate values for codes within this

### CMS-1600-FC 338

family from the relevant specialty societies. These so cieties raised several objections to the AMA RUC’s recommended values, including the in consistent data sources used for determining the time for this

recommendation relative to its last recommendation in 2005, concerns regarding the thoroughness of the AMA RUC’s review of the services, and questions regard ing the appropriate number of visits estimated to be furnished within the global period for the codes. We have examined the information presented by the specialty societies and the AMA RUC regarding these services and we share concerns raised by stakeholders regarding the appropriate valuation of these services, especially related to using the most accurate data source available for determining the intraservice time involved in furnishing PFS services. Specifically, there appears to be significant variation between the time values estimated through a survey versus those collected through specialty databases. However, we also note that the AMA RUC, in making its recommendation, acknowledged that there has been a change in the source for time estimates since these services were previously valued. We note that one source of disagreement regard ing the appropriate valuation of these services result from differing views as to the postoperative visits that typically occur in the global period for both of these procedures. The AMA RUC recommended includi ng three inpatient postoperative visits (2 CPT code 99231 and one CPT code 99232), one discharge da y management visit (99238), and three outpatient postoperative office visits (1 CPT code 99212 and 2 CPT code 99213) in the global periods for both CPT codes 27130 and 27447. The specialty societies agr eed with the number of visits included in the AMA RUC recommendation, but contended that the visits were not assigned to the appropriate level. Specifically, the specialty societies believe that the three inpatient postoperativ e visits should be 1 CPT code 99231 and 2 CPT code 99232. Similarly, the specialty societies indicated that the three outpatient postoperative visits should all be CPT code 99213. The visits recommended by the specialty societies would result in greater resources in the global period and thus higher work values. The divergent recommendations from the specialty societies and the AMA RUC regarding the accuracy of the estimates of time for these services, including both the source of time estimates for the

### CMS-1600-FC 339

procedure itself as well as the inpatient and outpatient vis its included in the global periods for these codes, lead us to take a cautious appro ach in valuing these services. We agree with the AMA RUC’s recommendation to value CPT codes 27130 and 27447 equally so we are establishing the same CY 2014 interim fi nal work RVUs for these two procedures. However, based upon the information that we have at this time, we believe it is also appropriate to modify the AMA

RUC-recommended RVU to reflect the visits in th e global period as recommended by the specialty societies. This change results in a 1.12 work RVU increase for the visits in the global period. We added

the additional work to the AM A RUC-recommended work RVU of 19.60 for CPT codes 27130 and 27447, resulting in an interim final work RVU of 20.72 for both services. To finalize values for these services for CY 2015, we seek public comment regarding not only the appropriate work RVUs for these services, but also th e most appropriate reconc iliation for the conflicting information regarding time values for these services as presented to us by the physician community. We are also interested in public comment on the use of specialty databases as compared to surveys for determining time values. We are especially interest ed in potential sources of objective data regarding procedure times and levels of visits furnished during the global periods for the services described by these

codes. (4) Transcatheter Aortic Valve Re placement (TAVR) (CPT Code 33366) For the CY 2013 final rule with comment period, we reviewed and valued several codes within the transcatheter aortic valve replacement (TAVR) family including CPT Codes 33361 (transcatheter aortic valve replacement (tavr/tavi) with prosthetic valve; percutaneous femora l artery approach), 33362 (transcatheter aortic valve replacement (tavr/tavi) with prosthetic valve; open femoral artery approach), 33363 (transcatheter aortic valve replacement (tavr/ta vi) with prosthetic valve; open axillary artery approach), 33364 (transcatheter aortic valve replaceme nt (tavr/tavi) with prosthetic valve; open iliac artery approach) and 33365 (transcat heter aortic valve replacement (tavr/tavi) with prosthetic valve; transaortic approach (eg, median sternotomy, medi astinotomy)). For these codes, we finalized the CY

### CMS-1600-FC 340

2013 interim final values for CY 2014 (see section II.E. 2.a.ii.) For CY 2014, CPT created a new code in the TAVR family, CPT code 33366, (Trcath replace aortic value). The AMA RUC has recommended the median survey value RVU of 40.00 for CPT Code 33366. After review, we believe that a work RVU of 35.88, which is between the survey’s 25 th percentile of 30.00 and the median of 40.00, accurately reflects th e work associated with th is service. The median intraservice time from the survey for CPT code 33365 is 180 minutes and for CPT code 33366 is 195. Using a ratio between the times for these procedures we determined the current work RVU of 33.12 for

CPT code 33365 results in the work RVU of 35.88 fo r CPT code 33366. We believe that an RVU of 35.88 more appropriately reflects the work re quired to perform CPT code 33366 and maintains appropriate relativity among these five codes. We are establishing a CY 2014 interim final work RVU of

35.88 for CPT code 33366. (5) Retrograde Treatment Open Carotid Stent (CPT Code 37217) The CPT Editorial Panel created CPT Code 37217, effective January 1, 2014. The AMA RUC recommended a work RVU of 22.00, the median fro m the survey, and an intraservice time of 120

minutes. The AMA RUC identified CPT Code 37215 (Tran scatheter placement of intravascular stent(s), cervical carotid artery, percutaneous; with distal embolic protection), which has an RVU of 19.68, as the key reference code for CPT code 37217. For its recommendations, the AMA RUC also compared CPT code 37217 to CPT Code 35301 (thr omboendarterectomy, including patch graft, if performed; carotid, vertebral, subclavian, by neck incision), which h as a work RVU of 19.61, and CPT code 35606 (Bypass graft, with other than vein; carotid-subcla vian), which has a work RVU of 22.46. In our review, we used the same comparison codes for CPT code 37217 as the AMA RUC used in valuing CPT code 37217. To assess the work RVUs for CPT code 37217 rela tive to CPT code 35606, we compared the AMA RUC-recommended work RVUs af ter removing the inpatient and outpatient visits in each code’s 90-day global period, resulting in work RVUs of 15.39 and 15.85, respectively. Although these RVUs are similar, the intraservice times are not. CPT code 35606 has an intraservice time of 145

### CMS-1600-FC 341

minutes compared with 120 minutes for CPT code 37217. To address the variation in intraservice times,

we calculated a work RVU for CPT code 37217 that r esults in its work RVU having the same relationship

to its time as does CPT code 35606. This results in a work RVU of 13.12 for the intraservice time. Adding back the RVUs for the visits results in a to tal work RVU of 19.73. This value, along with the RVUs of the other comparison codes used by th e AMA RUC (CPT codes 37215 and 35301), supports our decision to establish a CY 2014 interim final work RVU of 20.38, the 25 th percentile of the survey. We believe that this work RVU of 20.38 more accurately reflects the work involved and maintains relatively among the other codes involving similar work. (6) Transcatheter Placement Intravascular Sten t (CPT Code 37236, 37237, 37238, and 37239) For CY 2014, the CPT Editorial Panel deleted four intravascular stent placement codes and created four new bundled codes, CPT codes 37236, 37237, 37238, and 37239. We agreed with the AMA RUC recommendations fo r all of the codes in the family except CPT code 37239. The AMA RUC recommended a work RVU of 3.34 for CPT code 37239, which they crosswalked to the work value of 35686 (Creation of distal arteriovenous fistula during lower extremity bypass surgery (non-hemodialysis) (List separately in addition to code for primary procedure)). CPT

code 37239 is the add-on code to 3 7238 for placement of an intravascu lar stent in each additional vein. The AMA RUC valued placement of a stent in the in itial artery (CPT code 37236) at 9.0 work RVUs and its corresponding add-on code (37237) fo r placement of a stent in an additional artery at 4.25 work RVUs. After review, we believe that the ratio of the work of placement of the initial stent and additional stents would be the same regardless of whether the stent is pl aced in an artery or a vein, and that the appropriate

ratio is found in the AMA RUC-recommended work RVUs of CPT codes 37236 and 37237. To determine the work RVU for CPT code 37239, we applied that ratio to the AMA RUC-recommended work RVU of 6.29 for CPT code 37238. Therefore, we are assigning an interim final work RVU of 2.97

to CPT code 37239 for CY 2014. (7) Embolization and Occlusion Procedures (CPT Codes 37241, 37242, 37243, and 37244)

### CMS-1600-FC 342

For CY 2014, the CPT Editorial Panel delete d CPT code 37204 (transcatheter occlusion or embolization (eg, for tumor destruction, to achieve hemostasis, to occlude a vascular malformation), percutaneous, any method, non-central nervous system , non-head or neck)) and created four new bundled codes to describe embolization and occlusion pro cedures, CPT codes 37241, 3 7242, 37423, and 37244. We agreed with the AMA RUC recommendations for CPT codes 37241 and 37244. However, we disagree with the AMA RUC-recommended work RVU of 11.98 for CPT code 37242. The AMA

RUC recommended a direct crosswalk to CPT code 34833 (Open iliac artery exposure with creation of conduit for delivery of aortic or iliac endovascular pros thesis, by abdominal or retroperitoneal incision, unilateral) because of the similarity in intraservice time. The service described by CPT code 37242 was previously reported using CPT codes 37204 (Transcat heter occlusion or embolization (eg, for tumor destruction, to achieve hemostasis, to occlude a vascular malformation), percutaneous, any method, noncentral nervous system, non-head or neck, 75894 (T ranscatheter therapy, embolization, any method, radiological supervision and inte rpretation), and 75898 (Angiography through existing catheter for follow-up study for transcatheter therapy, embolization or infusion, other than for thrombolysis). The

intraservice time for CPT code 37204 is 240 minutes and the work RVU is 18.11. The AMA RUCrecommended intraservice time for CPT code 37242 is 100 minutes. We believe that the AMA RUCrecommended work RVU does not adequately consider the substantial decrease in intraservice time for CPT code 37242 as compared to CPT code 37204. Therefore, we believe that the survey’s 25 th percentile

work RVU of 10.05 is consistent with the decrea ses in intraservice time and more appropriately reflects the work of this procedure. We also disagree with the AMA RUC-recommende d work RVU of 14.00 for CPT code 37243, which the AMA RUC crosswalked from CPT code 37244, which has a work RVU of 14.00. The AMA

RUC stated that work RVU of CPT codes 37243 and 37244 should be the same despite a 30-minute

intraservice time difference between the codes b ecause the work of CPT code 37244 (recommended intraservice time of 90 minutes) was more intense than CPT code 37243 (recommended intraservice time of 120 minutes). This service was previously re ported using CPT codes 37204, 75894 and 75898; or

### CMS-1600-FC 343

37210 (Uterine fibroid embolization (U FE, embolization of the uterine arteries to treat uterine fibroids, leiomyoma), percutaneous approach inclusive of v ascular access, vessel selection, embolization, and all radiological supervision and interpretation, in traprocedural roadmapping, and imaging guidance necessary to complete the procedure). The curre nt intraservice time for CPT code 37204 is 240 minutes

and the work RVU is 18.11. The current intraser vice time for CPT code 37210 is 90 minutes and the

work RVU is 10.60. The AMA RUC-recommended in traservice time for 37243 is 120 minutes. We do

not believe that the AMA RUC-recommended work RVU adequately considers the substantial decrease in intraservice time for CPT code 37243 as compared to CPT code 37204. We also note that the AMA recognized that CPT code 37243 is less intense than CPT code 37244. Therefore, we believe that the survey’s 25 th percentile work RVU of 11.99 more appropriate ly reflects the work required to perform this

service. (8a) Gastrointestinal (GI) Endoscopy (CPT Codes 43191-43453) In CY 2011, numerous esophagosc opy codes were identified as pot entially misvalued because they were on the CMS multi-specialty point s of comparison list. For CY 2014, the CPT Editorial Panel revised

the code sets for these services. The AMA RUC su bmitted recommendations for 65 codes that describe esophagoscopy, esophagogastroduodenoscopy (EGD), and endoscopic retrograde cholangiopancreatography (ERCP) of the esophagus, stomach, duodenum, and panc reas/gall bladder. In valuing this revised set of codes, we note that the AMA RUC recommendations included information demonstrating significant overall reducti on in time resources associated with furnishing these services. In the absence of information supporting an in crease in intensity, we would expect that the work

RVUs would decrease if there are reductions in time. However, the AMA RUC-recommended work

RVUs do not reflect overall reductions in work RVUs proportionate to the reductions in time. Therefore, we questioned the recommended work RVUs unl ess the recommendations included information indicating that the intensity of the work had increased. We note that in assigning values that maintain th e appropriate relativity throughout the PFS, it is extremely important to review a family of services together and we aim to address recommendations

### CMS-1600-FC 344

regarding potentially misvalued codes in the first possible rulemaking cycle. Therefore, we are establishing interim final values for these codes fo r CY 2014 although we do not have the AMA RUC recommendations for the remaining lower GI tract cod es. We expect to receive these recommendations in time to include them in the CY 2015 final rule with comment period. At that time, we may revise the

interim final values established in this final rule with comment period to address any family relativity issues that may arise once we have more complete information for the entire family. The AMA RUC used a number of methodologies in valuing these codes. These include accepting survey medians or 25th percentiles, crosswalking to other codes, and calculating work RVUs using the building block methodology. These are reviewed in section II.E.1. above. The AMA RUC also made extensive use of a methodology that uses the increm ental difference in codes to determine values for many of these services. This methodology, which we call the incremental difference methodology, uses a base code or other comparable code and considers wh at the difference should be between that code and another code by comparing the differentials to tho se for other similar codes. Many of the procedures described within the esophagoscopy subfam ily have identical counterparts in the esophagogastroduodenoscopy (EGD) subfamily. For instance, the base esophagoscopy CPT code 43200 is described as “Esophagoscopy, flexible, transora l; diagnostic, including collection of specimen(s) by brushing or washing when performed.” The base EGD CPT code 43235 is described as “Esophagogastroduodenoscopy, flexible, transoral; diagnostic , with collection of specimen(s) by brushing or washing, when performed.” In valuing other co des within both subfamilies, the AMA RUC frequently

used the difference between these two base codes as an increment for measuring the difference in work involved in doing a similar procedure utilizing esopha goscopy versus utilizing EGD. For example, the EGD CPT code 43239 includes a biopsy in addition to the base diagnostic EGD CPT code 43235. The AMA RUC valued this by adding the incremental difference in the base esophagoscopy code over the

base EGD CPT code to the value it recommended for the esophagoscopy biopsy, CPT code 43202. With some variations, the AMA RUC extensively used th is incremental difference methodology in valuing

subfamilies of codes. We have made use of si milar methodologies, in addition to the methodologies

### CMS-1600-FC 345

listed above, in establishing work RVUs for codes in this family. We have also made use of an additional methodology not typically utilized by the AMA RUC. As noted above in this secti on, we believe that the significant decreases in intraservice and total times for these services should result in corresponding changes to the work RVUs for the ser vices. In keeping with this princi ple, we chose, in some cases, to decrement the work RVUs for particular codes in direct proportion to the decrement in time. For example, for a CPT code with a current work RVU of 4.00 and an intraservice time of 20 minutes that decreases to 15 minutes following the survey, we mi ght have reconciled the 25 percent reduction in overall time by reducing the work RVU to 3.00, a reduction of 25 percent. (8b) Esophagoscopy The rigid and flexible esophagoscopy services are currently combined into one code, but under the new coding structure the services ar e separated into rigid transoral, flexible transnasal and flexible transoral procedure CPT codes. (8c) Rigid Transoral Esophagoscopy

To determine the interim final values for the rigid transoral esophagoscopy codes, CPT codes 43191, 43192, 43193, 43194, 43195, and 43196, we considered the AMA RUC-recommended intraservice times and found that the surveys showed th at half of the rigid transoral esophagoscopy codes had 30 minutes of intraservice time and a work RVU survey low of 3.00, a ratio of 1 RVU per 10 minutes (1 work RVU/10 minutes). This ratio was further supported by the relationship between the CY 2013 work value of 1.59 RVUs for CPT code 43200 (Esoph agoscopy, rigid or flexible; diagnostic, with or without collection of specimen(s) by brushing or w ashing (separate procedure)) and its intraservice time of 15 minutes. Based upon the 1 work RVU/10 minut es ratio, we are establishing CY 2014 interim final work RVU of 2.00 for CPT code 43191, 3.00 for CPT code 43193, 3.00 for CPT code 43194, 3.00 for CPT code 43195, and 3.30 for CPT code 43196. For CPT code 43192, the 1 work RVU/10 minute ratio resulted in a value that was less than the survey low, and thus did not appear to work appr opriately for this procedure. Therefore, we are establishing a CY 2014 interim final work RVU for CPT code 43192 of 2.45 based upon the survey low.

### CMS-1600-FC 346

(8d) Flexible Transnasal Esophagoscopy In recommending work RVUs for the two CPT c odes 43197 and 43198, which describe flexible transnasal services, the AMA RUC recommended th e same work RVUs as it recommended for the corresponding flexible transoral CPT codes (4320 0 and 43202). We believe these recommendations

overstate the work involved in the transnasal codes sin ce, unlike the transoral cod es, they are not typically furnished with moderate sedation. Therefore, to value CPT code 43197 and 43198, we removed 2 minutes of the pre-scrub, dress and wait preservice time from the calculation of the work RVUs that we are establishing for CY 2014 for CPT codes 43200 and 4320 2. We are establishing CY 2014 interim final

values of 1.48 for CPT code 43197 and 1.78 for CPT code 43198. (8e) Flexible Transoral Esophagoscopy

We established values for CPT codes 43216 through 43226 based on the AMA RUC

recommendations.

We used CPT code 43200 as the base code for ev aluating all the flexible esophagoscopy services. The CY 2013 code descriptor for 43200 includes bot h flexible and rigid esophagoscopy, while for CY 2014, the descriptor has been revised to include only fl exible esophagoscopy. Despite this change in the code descriptor for CY 2014, the AMA RUC-recomme nded maintaining a work RVU of 1.59 for this code. However, we believe that the rigid esophago scopy, described by the new CPT code 43191, is a more difficult procedure and by removing the rigid service from CPT code 43200 the intensity of services described by the revised CPT code 43200 are lowe r than the intensity of services described by the existing code. To establish an appropriate interim final value for the new code, we followed the 1 work RVU per 10 minutes of intraservice time methodology d escribed above resulting in an interim final work RVU of 1.50 for the service. This interim final work RVU valuation is further supported by the AMA

RUC’s recommendation that would decrease total time from 55 minutes to 52 minutes.

We believe that the work value difference be tween CPT code 43200 and 43202 as recommended by the AMA RUC is correct. Therefore, we adde d the difference in the AMA RUC recommended values for CPT codes 43200 and 43202, 0.30 RVUs, to CPT c ode 43200, resulting in a work RVU of 1.80 for

### CMS-1600-FC 347

CPT codes 43201.. We note that the resulting differe nce between 43200 a nd 43201 of 0.30 RVUs is also

similar to the 0.31 difference between the valu es the AMA RUC recommended for these two codes.

We also believe that the work involved in CPT c ode 43201 is similar to the work involved in CPT code 43202. Accordingly we are establishing a CY 2014 interim final work RVU of 1.80. For CPT code 43204, the AMA RUC recommended a work RVU of 2.89. We believe that this

code is similar to CPT code 43201 in that both codes involve injections in the esophagus. However, CPT code 43204 has 20 minutes of intraservice time compared to 15 minutes for CPT code 43201. Applying

this increase in intraservice time to the work RVU that we are establishing for CP T code 43201 results in

a work RVU of 2.40 for this code. The AMA RUC recommended a work RVU of 3.00 for CPT code 43205, an increment of 0.11 RVUs over its recomme nded value for CPT code 43204. Both of these codes involve treatment of esophageal varices. We agree with that increment and are adding that to our

CY 2014 interim final work RVU for CPT code 43204 of 2.40 to arrive at a CY 2014 interim final work

RVU of 2.51 for CPT code 43205. In establishing interim final work RVUs for C PT code 43211, we followed the methodology used by the AMA RUC to develop its recommendation. The AMA RUC decreased the work RVU of the corresponding esophagogastroduodenoscopy (EGD for mu cosal resection), CPT code 43254, by the difference between the base esophagoscopy code 43200 and the base EGD code 43235, which is 0.67 RVU. Reducing our CY 2014 interim final work R VU of 4.88 for CPT code 43254 by this difference

results in a CY 2014 interim final work RVU of 4.21 for CPT code 43211.

Since CPT code 43212 has almost identical times and intensities as CPT code 43214, we

crosswalked the work RVU from our CY 2014 interim final work RVU of 3.38. In valuing CPT code 432 13, we believe it is comparable to CPT code 43200, but has intraservice time of 45 minutes, while CPT code 43200 has only 20 minutes. We are establishing a CY 2014 interim final work RVU of 4.73, which is based upon the diff erence in intraservice time between the two codes CPT code 43214 is esophageal d ilatation using fluoroscopic guidance. We believe that the service described by CPT code 43214 is similar in intensity and intraservice time to CPT code 31622

### CMS-1600-FC 348

(Bronchoscopy, rigid or flexible, including fluorosco pic guidance, when performed; diagnostic, with cell washing, when performed (separate procedure)), a nother endoscopic code using fluoroscopic guidance. However, CPT code 43214 includes an endoscopic dilation in addition to the fluoroscopic guided endoscopy. Therefore, we added the incremental increase between the work RVU of the esophagoscopy base code for dilation without fluoroscopic guidance, CPT code 43220, and the base code to the work RVU for CPT code 31622 and are establishing a CY 2014 interim final work RVU of 3.38 for CPT code

43214.

We believe that the time and work for CPT 43215 are identical to those for CPT code 43205. Therefore, we crosswalked the work RVU for CPT code 43215 to CPT code 43205, and are establishing a

CY 2014 interim final work RVU of 2.51. For current CPT code 43227, the survey reflected a decrease in intraservice time from the current, 36 minutes to 30 minutes. The AMA RUC recommended a small decrease in RVUs, but not one that was proportionate to the difference in intraservice time. Therefore, we decreased the current work RVU proportionate to the decrease in intraservice time, resulti ng in a CY 2014 interim final work RVU of 2.99. CPT code 43231 is a basic esophagoscopy pro cedure done with endoscopic ultrasound. We disagree with the AMA RUC recommendation to mainta in the current work RVU of 3.19, despite a decrease in intraservice time. Instead, we used the work RVU of another endoscopic code using endoscopic ultrasound to value the incremental di fference in work between this service and the esophagoscopy base code. CPT c ode 31620 (Endobronchial ultras ound (EBUS) during bronchoscopic diagnostic or therapeutic intervention(s) (List separatel y in addition to code for primary procedure[s])) is an add-on code for EBUS to other bronchoscopy cod es, with a current work RVU of 1.40. We added

this EBUS work RUV to the work RVU of base esophagoscopy code 43200 and are establishing a CY

2014 interim final work RVU of 2.90. For CPT code 43232, we believe that the work value difference between CPT code 43231 and 43232 as recommended by the AMA RUC is correct. We added that difference of 0.64 work RVUs to

### CMS-1600-FC 349

our CY 2014 interim final work RVU for CPT code 43231 to arrive at our CY 2014 interim final work

RVU of 3.54 for CPT code 43232. CPT code 43229 has similar times and intensity to CPT code 43232 and therefore, we directly

crosswalked the work value of CPT code 43229 to CPT code 43232, resulting in a CY 2014 interim final

work RVU of 3.54. (8f) Esophagogastroduodenoscopy (EGD) Various EGD codes were identified as potentiall y misvalued through the multi-specialty point of comparison, high expenditures, and fastest growing screens. The AMA RUC recommended values for all EGD codes. We agreed with the AMA RUC recomme nded values and are esta blishing CY 2014 interim final work RVUs for CPT codes 43240, 43241, 43243, 43244, 43245, 43248, 43249, 43250, and 43251

based on its recommendations. In reviewing the base EGD code, CPT code 43235, we determined that we agreed with the AMA RUC’s recommended work RVU difference between this EGD base code and the esophagoscopy base code, CPT 43200. We applied this difference to our CY 2014 interim final work RVU of 1.50 for CPT code 43200 and are establishing a CY 2014 interim final RVU of 2.17 for CPT code 43235. CPT code 43233 is an identical procedure to CP T code 43214 except that it uses EGD rather than esophagoscopy. We added the additional work RVU of furnishing an EGD as compared to an esophagoscopy to our CY 2014 interim final work RV U of 3.38 for CPT code 43214, resulting in a CY

2014 interim final work RVU of 4.05 for CPT 43233. CPT code 43236 is the EGD equivalent of the esophagoscopy CPT code 43201. In valuing CPT code 43236, the AMA RUC used the incremental di fference methodology using CPT codes 43200 and

43201 and added that difference to its recommended wo rk value for CPT code 43235 to arrive at its

recommended RVU of 2.57 for CPT code 43236. We us ed the same methodology but instead of using the

AMA RUC recommended work RVU fo r CPT code 43235, we used our CY 2014 interim final value of

2.17 for CPT code 43235. We are es tablishing a CY 2014 interim final work RVU of 2.47 for CPT code

43236.

### CMS-1600-FC 350

CPT code 43237 is the EGD equivalent to the esophagoscopy CPT code 43231. We do not believe that the AMA RUC-recommended work RVU adequately accounts for the 20 percent decrease from current

time to the AMA RUC-recommended intraservice time. Therefore, we applied an incremental difference methodology as discussed above for CPT code 43233. We used the comparable esophagoscopy code 43231

and added its CY 2014 interim final work RVUs to the incremental value of a base EGD over the base esophagoscopy, resulting in a CY 2014 interim final work RVU of 3.57 for CPT code 43237. CPT code 43238 is the EGD equivalent to the esophagoscopy CPT code 43232. We valued this code similarly to CPT code 43237 usi ng the incremental difference approa ch. We do not believe that the

AMA RUC recommended RVU ad equately accounts for the 36 percent de crease in intraservice time. We

used the CY 2014 interim final work RVU for the comparable esophagoscopy CPT code 43232 and added

that to that the incremental work RVU of an EGD over esophagoscopy, resulting in a CY 2014 interim final

work RVU of 4.11 for CPT code 43238. CPT code 43239 is the EGD equivalent to th e esophagoscopy CPT code 43202 and we used the

incremental difference met hodology described above. We do not believe that the AMA RUC recommended RVU adequately accounts for the 56 pe rcent decrease in intraservice ti me. We used the CY 2014 interim final work RVU for the comparable esophagoscopy code 43202 and added that to the incremental work RVU value of an EGD over esophagoscopy, resulting in a work RVU of 2.47, whic h we are esta blishing as

the CY 2014 interim final work RVU for CPT code 43239. CPT code 43242 is an equivalent service to CPT code 43238 except that CPT code 43242 includes diagnostic services in a surgica lly altered GI tract. The AMA RU C recommendation used a methodology

that took the increment between CPT code 43238 and C PT code 43237, which is an ultrasound examination of a gastrointestinal (GI) tract that has not been su rgically altered. The AMA RUC then applied that

difference in its recommended work RVUs for thes e two codes to CPT code 43259, which is an ultrasound of a GI tract that has been surgically altered. We agree with that methodology but instead applied our CY

2014 interim final work RVUs for thos e codes. Accordingly, we are es tablishing a CY 2014 interim final

RVU of 4.68 for CPT code 43242.

### CMS-1600-FC 351

In valuing CPT code 43246, we note that the work and time are very similar to CPT code 43255. Therefore, we directly crosswalke d the service to the CY 2014 interi m final work RVU of CPT code 43255 and are establishing a CY 2014 interim final value of 3.66. CPT code 43247 is the EGD equivalent to the esophagoscopy CPT code 43215. In valuing this code, the AMA RUC applied the in crement between CPT code 43200 and 43215 to the EGD base CPT

code 43235 to arrive at its recommended RVU of 3.27. We agree with this methodology but applied the values we have established for these codes, resu lting in a work RVU of 3.18 for CPT code 43247. In valuing CPT code 43253, the AMA RUC applied th e same methodology as it used in valuing CPT code 43242, resulting in a reco mmended RVU of 5.39. We agree with that methodology, but instead of using the AMA RUC-recommended values, we are usi ng our CY 2014 interim fina l work RVUs. We are establishing a CY 2014 interim final work RVU of 4.68 for CPT code 43253. CPT code 43254 is the EGD equivalent to th e esophagoscopy CPT code 43211. The AMA RUCrecommended a work RVU of the survey’s 25 th percentile of 5.25. We believe that this overstates the work

involved in this code and that the incremental methodo logy used by the AMA RUC for many of these codes is more appropriate. Thus, we applied the increm ental difference methodology between the base EGD and esophagoscopy codes to the equiva lent esophagoscopy CPT code 43211 and are establishing a CY 2014

interim final RVU of 4.88. CPT code 43255 is the EGD equivalent to the esophagoscopy CPT code 43227. We do not believe that the AMA RUC-recommended 13 percent work RV U decrease adequately accounts for the 44 percent

decrease in intraservice time. Ther efore, we applied the incremental difference methodology, using our CY 2014 interim final values and the comparable esophagosc opy code, CPT code 43227. We are establishing a

CY 2014 interim final work RVU of 3.66 for CPT code 43255. CPT code 43257 is a CY 2013 code for which the AMA RUC recommended the survey’s 25 th percentile. We note that the service has an identical intraservice time and similar intensity to CPT code 43238. Thus, we directly crosswalked the work RVU from CPT code 43238 to CPT code 43257. We are

### CMS-1600-FC 352

establishing a CY 2014 interim final work RVU of 4.11 for CPT code 43257, which is consistent with the 25 percent reduction from curren t intraservice time. In valuing CPT code 43259, the AMA RUC recommended the survey’s 25 th percentile RVU of 4.74. We disagree with that value and note that the intraservice time has decreased 35 percent and the total time has decreased 20 percent. Applying the intras ervice time decrease to the CY 2013 work RVU would

result in an RVU of 3.38. We believe that value does not maintain the appropriate rank order with the other EGD codes. Adjusting the current RVU to account for th e reduction in total time results in a work RVU of 4.14. We believe that this work RVU more accurately values the work involved in this service. Thus, we are establishing a CY 2014 interim final RVU of 4.14 for this code. CPT code 43266 is the EGD equivalent to the esophagoscopy CPT code 43212. In valuing CPT code 43266, the AMA RUC reco mmended the survey’s 25 th percentile RVU of 4.40, higher than the current value of 4.34 even though the intraservi ce time decreased from 45 minutes to 40 minutes. We disagree with this recommended work RVU . Therefore, we used the incremental difference methodology and added the

difference in work RVUs between th e base esophagoscopy code and the base EGD code to the equivalent esophagoscopy CPT code 43212 for an RVU of 4.05. Thus, we are establishing a CY 2014 interim final

work RVU of 4.05 for CPT code 43266. CPT code 43270 is the EGD equivalent to th e esophagoscopy CPT code 43229. The AMA RUC recommended the survey’s 25 th percentile work RVU of 4.39. We di sagree with this value and believe that utilizing the incremental diffe rence methodology more accurately determ ines the appropriate work for this service. For CPT code 43270, we added the difference in work RVUs between the base EGD code over the base esophagoscopy code to our CY 2014 interim final work RVU fo r CPT 43229, resulting in a work RVU of 4.21. Thus, we are establishing a CY 2014 in terim final value of 4.21 for CPT code 43270. (8g) Endoscopic Retrograde Cholangiopancreatography In CY 2011, several endoscopic retrograde c holangiopancreatography (ERCP) codes were identified by CMS through the multi-specialty poin ts of comparison screen. The AMA RUC provided

recommendations for seven current codes and five new codes. CPT codes 43260 -43265 and 43273 -

### CMS-1600-FC 353

43278 were reviewed. We agreed with the AM A RUC-recommended values for CPT codes 43260, 43261, 43262, 43264, 43265, 43273, 43275, and 43277 as shown on Table 27.

The AMA RUC recommended that the work RVU for CPT code 43263 be maintained at its current RVU of 7.28 in spite of a 25 percent decreas e to its recommended intraservice time for this code.

This code has identical times to CPT code 43262 for which the AMA RUC recommended a decrease in the work RVU from its current value of 7.38 to 6.60, consistent with the decrease in time. We believe that this reduction more accurately reflects the work involved in this code, so we crosswalked the work

RVU for CPT code 43263 to CPT code 43262. We ar e establishing a CY 2014 interim final work RVU of

6.60 for CPT code 43263. CPT code 43274 is a new code involving sten t placement and sphincterotomy. The AMA RUC valued this code by adding the increment of a sphi ncterotomy and stent placeme nt to the work RVU of the base ERCP, CPT code 43260, resulting in an AMA RUC-recommended work RVU of 8.74. We agree with this methodology, except we have used our CY 2014 interim final work RVUs. We are establishing an interim final RVU of 8.48 for CPT code 43274.

CPT code 43276 is a new code w ithout previous physician times to compare that involves the removal and replacement of a stent. The AMA RUC developed its recommendation using the incremental difference methodology. It determined the incremental work RVU associated with removing a foreign body by comparing CPT code 43215 to the base esophagoscopy code, CPT code 43200. It also determined the incremental value of placing a sten t with esophagoscopy, CPT code 43212, over the base esophagoscopy, CPT code 43200. By adding these two increments to the work RVU of the ERCP base code, CPT code 43260, the AMA recommended a work RVU for CPT code 43276 of 9.10. The median survey value was 9.88 and the survey’s 25 th percentile was 6.95. The combination of 60 minutes of intraservice time with an RVU of 9.10 is not comparab le with other ERCP codes. For CPT code 43274, for example, the AMA RUC recommended 68 minutes intraservice time and a work RVU of 8.74. We accepted the AMA RUC recommendations for CPT code 43265 of 78 minutes intraservice time and a

work RVU of 8.03. Both CPT codes 43262 and 432 63 have intraservice times of 60 minutes and a CY

### CMS-1600-FC 354

2014 interim final work RVU of 6.60. Based on these comparisons, we believe that the AMA RUC

recommendation for this code of 9.10 is inconsiste nt with the RVUs assigned to codes that describe

similar services with similar intraservice times. Th erefore, we are using the incremental difference methodology to arrive at the appropriate work RVU. CPT code 43275 describes the removal of a stent using ERCP. We used CPT code 43275 with a CY 2014 interim final work RVU of 6.96 and added the incremental difference of placing a stent utilizi ng esophagoscopy, CPT code 43212, over the base esophagoscopy code CPT code 43200. We believe that this valuation approach results in values that are

more consistent with other codes in this fa mily than the AMA RUC recommendation. We are establishing a CY 2014interim final RVU of 8.84 for CPT code 43276.

CPT code 43277 is a new code for CY 2014, which describes ERCP with dilation and if furnished, sphincterotomy. The AMA RUC recomme nded a work RVU of 7.11 RVU. The AMA RUC determined this value using an incremental appro ach. Specifically, the wo rk RVU for dilation was calculated as the difference between the esophago scopy dilation code (CPT code 43220) and the esophagoscopy base code, CPT code 43200, and the s phincterotomy work RVU was calculated as the difference between the base ERCP code, CPT 43260, and the ERCP sphincterotomy code, CPT code 43262. By adding these two values to the work R VU of CPT code 43260, the AMA RUC calculated its

recommended work RVU of 7.11. The su rvey’s 25th percentile is 7.00. Currently, ERCP sphincterotomy is billed using a single code, CPT code 43262, and duct dilation using ERCP is currently billed using CPT code 43271 . Adding together the current work RVUs for these

two codes results in a RVU of 8.81. The total co mbined intraservice time for these two codes is 90

minutes. Since the new CPT code 43277 has an in traservice time of only 70 minutes, we applied the percentage decrease in time to the current combined work RVU for CPT 43262 and 43271 of 8.81, resulting in a work RVU of 6.85. Although this value reflects a proportional reduction in intraservice time between the current codes and the time presu med for the AMA RUC recommendation, we believe that a work RVU of 6.85 does not adequately reflect the intensity of this service and are therefore establishing an interim final RVU for CPT code of 432 77 of 7.00, which is the survey’s 25th percentile.

### CMS-1600-FC 355

CPT code 43278 is a new code involving lesion ablation. The AMA RUC valued this code by adding the incremental work RVU difference between the base esophagoscopy code and the esophagoscopy ablation code, CPT code 43229, to the b ase ERCP code, resulting in a RVU of 8.08. We agree with this methodology. However, using our CY 2014 interim final values we are establishing a CY

2014 interim final work RVU of 7.99. (8h) Dilation of Esophagus We agree with the AMA RUC recommended values for the dilation of the esophagus, CPT codes 43450 and 43453, as shown on Table 27. (9) Transplantation of Kidney (CPT Code 50360)

We received an AMA RUC work RVU recomme ndation of 40.90 for CPT code 50360 which

included an increase in the service’s intraservice ti me, from 183 minutes to 210 minutes. We also note that there is a significant decrease in the number of AMA RUC-recommended visits in the global period for this procedure. In CY 2006, the work RVU for CPT 50360 was 31.48. In CY 2007 and CY 2010, the work RVUs for all services with global periods, including C PT code 50360, were increased to take into account

increases in the work RVUs for E/M services. These changes resulted in the current work RVU for CPT code 50360 of 40.90. We note that this increase was based on an assumption of 32 visits in the global period. Based upon information that we now have, it appears that an assumption of 10 visits may have been more appropriate. If we had used an assumpti on of 10 visits when adding E/M services in 2007 and 2010, the current work RVU would be 34.68. In determining a CY 2014 interim final work RVU, we began with the 34.68 work RVU value. The AMA RUC recommended a 14.75 percent increase in intraservice time, from 183 min to 210 min. Applying this ratio to the refined base work RVU of 34.68 results in a new base work RVU of 39.80. Adding the changes in work RVU resulting from th e changes in the preservice and postservice times recommended by the AMA RUC results in an interi m final work RVU of 39.88 for CPT code 50360. (10) Spinal Injections (CPT Codes 62310, 62311, 62318, and 62319)

### CMS-1600-FC 356

For CY 2014, we received AMA RUC recomme ndations for CPT codes 62310, 62311, 62318, and 62319. Although the AMA RUC recommendations show a significant reduction in intraservice and total times for the family, the recommended wo rk RVUs do not reflect a similar decrease. For CPT code 62310, we disagree with the work RVU of 1.68 recommended by the AMA RUC

because the reduction from the current work is not co mparable to the 63 percent reduction in time being recommended by the AMA RUC. We, however, agree that the methodology used by the AMA RUC to develop a recommendation was appropriate. Using this methodology, we calculated the difference in the

AMA RUC recommendations for CPT 62310 and 62318 an d subtracted this from our CY 2014 interim work RVU for CPT 62318, which results in a work RVU of 1.18, which we are establishing as the CY

2014 interim final work RVU for CPT code 62310. The AMA RUC recommended maintaining the current work RVU for CPT code 62311 of 1.54 even though its recommended intraservice time decr eased 50 percent. We disagreed with this approach.To determine the CY 2014 interim final work RVU we subtracted the difference between the

AMA RUC-recommended work RVUs of 62311 and 6 2319 from our CY 2014 interim final work RVU

for CPT code 62319. We believe that the resultant work RVU of 1.17 is a better approximation of the

work involved in CPT code 62311. CPT code 62318 currently has an intraservice time of 20 minutes and a work RVU of 2.04. The intraservice time reduced by 25 percent but the AMA RUC recommended no change in the work RVU. The low value of the survey is 1.54, which is c onsistent with the reduction in intraservice time. Therefore, we are establishing an interi m final RVU for CPT code 62318 of 1.54. The AMA RUC recommended a 50 percent decrease in intraservice time for CPT 62319 but no change in the work RVU. Similar to the CPT c ode 62318, we believe the low value of 1.50 more accurately represents the work involved in the code and the significant reduction in intraservice time. (11) Laminectomy (CPT Codes 63047 and 63048) We identified CPT code 63047 through the high expenditure procedure code screen. For CY 2014, we received AMA RUC recommendations on CPT codes 63047 and 63048.

### CMS-1600-FC 357

In reviewing the AMA RUC recommendations for these codes, we determined that to appropriately value these codes, we need to consider the other two codes in this family: CPT codes 63045 (Laminectomy, facetectomy and foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [eg, spinal or lateral recess stenosis]), single vertebral segment;

cervical ) and 63046 (Laminectomy, facetectomy and fora minotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerv e root[s], [eg, spinal or lateral recess stenosis]), single vertebral segment; thoracic). Since the AMA RUC did not submit recommendations for these codes, we are valuing CPT codes 63047 and 63048 on an interim final basis for CY 2014 at work RVUs of 15.37 and 3.47, respectively, based upon the AMA RUC recommendations. We note that expect to

review these values in concert with the AMA RU C recommendations for CPT codes 63045 and 63046. (12) Chemodenervation of Neck Muscles (CPT Codes 64616 and 64617) For CY 2014, we received AMA RUC recommenda tions for two new chemodenervation codes, CPT codes 64616 and 64617, which replace CPT code 64613 (chemodenervation of muscle(s); neck muscle(s) (eg, for spasmodic to rticollis, spasmodic dysphonia)). We disagree with the AMA RUCrecommended work RVUs of 1.79 for CPT code 64616 and 2.06 for CPT code 64617. We do not think

that these recommended values account for the absence of the outpatient visit that was included in the predecessor code, CPT 64613. To adjust for this, we subtracted the 0.48 work RVUs associated with the outpatient visit from the 2.01 work RVU of the pred ecessor code, CPT code 64613; resulting in a work RVU of 1.53, which we are assigning as an interim final value for CPT 64616. CPT code 64617 is chemodenervation of the larynx and includes EMG guidance when furnished. The EMG guidance CPT code 95874 (Needle electrom yography for guidance in conjunction with chemodenervation (List separately in addition to code for primary procedure)) has a work RVU of 0.37.

To calculate the work RVU for CPT 64617 we adde d the work RVU for CPT 95874, EMG guidance, to the 1.53 work RVU for CPT 64616, which results in a work RVU of 1.90. Therefore, on an interim final basis for CY 2014, we are assigning a work RVU of 1.53 to CPT

code 64616 and 1.90 to CPT code 64617.

### CMS-1600-FC 358

(13) Chemodenervation of Extremity or Trunk Muscles (CPT Codes 64642, 64643, 64644, 64645, and 64647) For CY 2014, the CPT Editorial Panel created six new codes to more precisely describe chemodenervation of extremity and trunk muscles. We assigned CY 2014 interim final work RVUs for four of these CPT codes (64642, 64644, 64646 and 64 647), based upon the AMA RUC recommendations.

CPT Codes 64643 and 64645 are add-on codes to CPT codes 64642 and 64644, respectively. We disagree with the AMA RUC-recommended work RVUs of 1.32 for CPT code 64643 and 1.52 for CPT code 64645. We agree with the AMA RUC that the intraservice times for each base code and its add-on code should be the same. However, the AMA RU C-recommendations for the add-on codes contain 19

minutes less time than the base codes because of d ecreased preservice and post- times in the add-on codes. Therefore, we are adjusting the add-on cod es by subtracting the RVUs equal to 19 minutes of preservice and postservice from the AMA RUC recomme nded work RVU for each base code to account for the decrease in time for performing the add-on service. Using the methodology outlined above, we are assigning a CY 2014 interim final work RVU for CPT code 64643 of 1.22 and a work RVU for CPT

code 64645 of 1.39. We are basing the global period for these codes on their predecessor code, CPT code 64614 (chemodenervation of muscle(s); extremity and/or tr unk muscle(s) (eg, for dystonia, cerebral palsy, multiple sclerosis)), which is being deleted for CY 2014. Therefore, we are assigning these codes a 010- day global period. (14) Cerumen Removal (CPT Code 69210) This code was reviewed as a potentially misval ued code pursuant to the CMS high expenditure screen. The CPT Editorial Panel changed the code d escriptor for removal of impacted cerumen from “1 or both ears” to “unilateral,” effective January 1, 2014. The AMA RUC recommended a work RVU for

this code of 0.58. In its recommendation to the AMA RUC, the specialty society stated that there was no

information to determine how often the service was performed unilaterally but asserted, and the AMA RUC agreed, that the service was performed bilatera lly 10 percent of the time. In determining its

### CMS-1600-FC 359

recommendation, the AMA RUC applied work neutrality to the current work RVU of 0.61 to arrive at the recommended work RVU of 0.58 based upon the assertion th at the code that was previously only reported once if furnished bilaterally, would now be repor ted for two units, due the descriptor change. We disagree with the assumption by the AMA RUC th at the procedure will be furnished in both ears only 10 percent of the time as the physiologic pr ocesses that create cerumen impaction likely would affect both ears. Given this, we will continue to allow only one unit of CPT 69210 to be billed when furnished bilaterally. We do not believe the AMA RUC’s recommended value reflects this and therefore,

we will maintain the CY 2013 work value of 0.61 for CPT code 69210 wh en the service is furnished. (15) MRI Brain (CPT Code 70551, 70552, 70553, 72141, 72142, 72146, 72147, 72148, 72149, 72156, 72157, and 72158) For CY 2014, the AMA RUC reviewed the family of magnetic resonance imaging (MRI) for the brain (CPT codes 70551, 70552, and 70553) and the family for MRI for the spine (CPT codes 72141,72142, 72146, 72147, 72148, 72149, 72156, 72157, and 72158). We are assigning the AMA RUCrecommended work RVUs as CY 2014 interim final va lues for all of these codes except for CPT code

70553.

The AMA RUC found that the codes in these two fa milies required a similar amount of work and

valued the codes with similar wo rk identically, except for CPT code 70553, which is the MRI code for brain imaging. CPT code 70553 is brain imaging without contrast followed by brain imaging with

contrast. The AMA RUC recommended that the work R VU for this code remain at its current value of 2.36, while recommending that the work RVUs of CPT codes 72156, 72157 a nd 72158 be decreased to

2.29. These three codes are similar to CPT code 70553 in that they identify MRI services without contrast followed by contrast for the three sections of the spine—cervical, thoracic and lumbar. We agree

with the AMA RUC that the work is similar for the two families of codes and that the codes should be valued accordingly. The AMA RUC-recommended value for CPT code 70553 is not consistent with the determination that these codes require a similar amount of work. Therefore, we are assigning a CY 2014

interim final work RVU of 2.29 to CPT code 70553.

### CMS-1600-FC 360

(16) Molecular Pathology (CPT Code 81161)

The AMA RUC submitted a recommended value for CPT code 81161, a newly created molecular pathology code, for CY 2014. Consistent with our policy established in the CY 2013 final rule with comment period that molecular pathology codes are paid under the CLFS as lab tests, rather than under the PFS as physician services, we are assigning CPT c ode 81161, a PFS procedure status indicator of X (Statutory exclusion (not within definition of ‘physician service’ for physician fee schedule payment purposes. Physician Fee Schedule does not allow pa yment, but perhaps another Medicare Fee Schedule does)). (77 FR 68994-69002). As explained in the CY 2013 final rule with comment period, HCPCS code G0452 can be used under the PFS by a physicia n to bill for medically necessary interpretation and written report of a molecular pathology test, above and beyond the report of laboratory results. (17) Immunohistochemistry (CPT Codes 88342 and 88343) The CPT Editorial Panel revised the existing immunohistochemistry c ode, CPT code 88342 and

created a new add-on code 88343 for CY 2014. Curre nt coding requirements only allow CPT code 88342 to be billed once per specimen for each antibody, but the revised CPT codes and descriptors would allow the reporting of multiple units for each slide and each block per antibody (88342 fo r the first antibody and 88343 for subsequent antibodies). We believe that this coding wo uld encourage overutilization by allowing multiple blocks and slides to be billed. To avoid this incentive, we are creating G0461 (Immunohistochemistry or immunocytochemistry, per specimen; first single or multiplex antibod y stain) and G0462 (Immunohistochemistry or immunocytochemistry, per specimen; each additional single or multiplex antibody stain (List separately in addition to code for primary procedure)) to en sure that the services are only reported once for each antibody per specimen. We believe this will resu lt in appropriate values for these services without creating incentives for overutilization.

We examined the AMA RUC recommendations for work RVUs CPT codes 88342 and 88343 in order to determine whether it would be appropria te to use these recommendations as the basis for establishing work RVUs for the new G-codes. To determine whether the AMA RUC-recommended work

### CMS-1600-FC 361

RVUs were appropriate for use in valuing the ne w G-codes, we examined whether the change in descriptors between the CPT and G-codes would change the underlying assumptions regarding the physician work and resource costs of the typical ser vices described by the codes. We note that the existing CPT code 88342 is to be re ported per specimen, per antibody. To crosswalk the utilization for the service described by the current CPT code 88342 to the new CPT coding structure, the AMA RUC recommended that 90 percent of the utilization prev iously reported with CPT code 88342 would continue to be reported with as a single unit of 88342 and that 10 percent of the utilization previously reported with CPT code 88342 would be reported with the new add-on c ode, CPT code 88343. It seems clear, then, that in recommending values for the new services, the AMA RUC did not anticipate that any additional services would be reported despite the new descriptors that would allow for units to be reported for each block and each slide for each antibody. Therefore, we assume that the AMA RUC’s recommended work RVUs and direct PE inputs for the new CPT codes were also developed with the assumption that the typical case would continue to be one unit reported per specimen, per antibody. Since the descriptors for the G-codes we are adopting in lieu of the new and revised CPT codes make explicit what appears to be the premise underlying the AMA RUC-recommended values for these services, we believe it is appropriate to use the AMA RUC recommendations for CPT codes 88342 and 88343 as the basis for establishing interim final work RVUs and direct PE inputs for the new G-codes for CY 2014. Therefore, we are assigning an interim final wo rk RVU of 0.60 for code G0461, which is the AMA RUC recommendation for CPT code 88342; and we are assigning an interim final work RVU of 0.24 for code G0462, which is the AMA RU C recommendation for CPT code 88343. (18) Psychiatry (CPT Code 90863) For CY 2013, the CPT Editorial Panel restructured the psychiatry/psychotherapy CPT codes allowing for separate reporting of E/M codes, eliminat ing the site-of-service differential, creation of CPT codes for crisis, and a series of add-on CPT codes to psychotherapy to describe interactive complexity and medication management. In CY 2013, the AM A RUC provided us with recommendations for the majority, but not all, of the updated psychiatry/psychotherapy CPT codes. Due to the absence of AMA

### CMS-1600-FC 362

RUC recommendations for the entire family, we establis hed interim final values for the codes based on a general approach of maintaining the previous values for the services, or as close to the previous values as possible, pending our receipt of recommended values fo r all codes in the new structure in CY 2014. See section II.E.2.a.ii.(25) of this final rule with comment period for a discussion of the finalization of the CY

2013 interim final RVUs. For CY 2014, we received the outstanding AMA RUC recommendations for the psychiatry/psychotherapy CPT code family. We are establishing interim final work RVUs for CPT codes 90785, 90839, and 90840 b ased upon the AMA RUC’s recommended work RVUs. We are assigning CPT code 90863 a PFS procedure status indicator of I (Not valid for Medicare purposes. Medicare uses another code for the reporti ng of and the payment for these services.).The CPT

Editorial Panel created CPT add-on code 90863 to describe medication management by a nonphysician when furnished with psychotherapy. As detailed in the CY 2013 final rule with comment period, clinical psychologists are precluded from billing Medicare for pharmacologic management services under CPT code 90863 because pharmacologic management servi ces require some knowledge and ability to perform evaluation and management services, as some stakeholders acknowledged. (19) Speech Evaluation (CPT Codes 92521, 92522, 92523, and 92524) For CY 2014, the CPT Editorial Panel replaced CPT code 92506 (evalua tion of speech, language, voice, communication, and/ or auditory processing) with four new speech evaluation codes, CPT codes 92521, 92522, 92523, and 92524, to more accurately describe speech-language pathology evaluation

services. We are assigning CY 2014 interim final work RVUs of 1.75 and 1.50 for CPT codes 92521 and 92522, respectively, as the HCPAC recommended. For CPT code 92523, we disagree with the HC PAC-recommended work RVU of 3.36. In arguing that this service should have a higher work R VU than the survey median of 1.86, the affected specialty society stated that its survey results were faulty for th is CPT code because surveyees did not consider all the work necessary to perform the service . We believe that the appropriate value for 60

### CMS-1600-FC 363

minutes of work for the speech evaluation codes is reflected in CPT code 92522, for which the HCPAC

recommended 1.50 RVUs. Because the intraservice time for CPT code 92523 is twice that for CPT code 92522, we are assigning a work RVU of 3.0 to CPT code 92523. Similarly, since CPT codes 92524 and 92522 have identical intraservice time recommendations and similar descriptions of work we believe that the work RVU for CPT code 92524 should be the same as the work RVU for CPT code 95922. Therefore, we are assigning a work RVU of 1.50 to CPT code

92524. Additionally, it is important to note that th ese codes are defined as “always therapy” services, regardless of the type of practitioner who performs them. As a result, CPT code s 92521, 92522, 92523 and 92524 always require a therapy modifier (GP, GO, or GN). Also, as noted in Addendum H, these codes will be subject to the therapy MPPR. In accordance with longstanding Medicare policy, we also note that in general, we would expect that only one evaluation code would be billed for a therapy episode of care. (20) Cardiovascular: Cardiac Catheterization (93582) For CY 2014, we reviewed new CPT code 93582. Although the AMA RUC compared this code to CPT code 92941 (percutaneous transluminal revasc ularization of acute total/subtotal occlusion during acute myocardial infarction, coronary artery or coronary), which has a work RVU of 12.56 and 70 minutes of intraservice time, it recommended a work RVU of 14.00, the survey’s 25th percentile. We agree with the AMA RUC that CPT code 92941 is an a ppropriate comparison code and believe that due to the similarity in intensity and time that the codes shoul d be valued with the same work RVU. Therefore, we are assigning an interim final work RVU of 12.56 to CPT code 93582 for CY 2014. (21) Duplex Scans (CPT Codes 93880, 93882, 93925, 93926, 93930, 93931, 93970, 93971, 93975, 93976, 93978 and 93979) CPT Code 93880 was identified as a high expenditu re procedure code and referred to the AMA RUC for review. As part of its recommendations , the AMA RUC included recommendations for CPT

### CMS-1600-FC 364

code 93882. The AMA RUC recommended an incre ase in the work RVUs for 92880 and 92882 from 0.60 and 0.40 to 0.80 and 0.50, respectively. In the 2013 PFS final rule with comment peri od, we reviewed 93925 (Duplex scan of lower extremity arteries or arterial bypass grafts; comple te bilateral study) and 93926 (Duplex scan of lower extremity arteries or arterial bypass grafts; unilateral or limited study), which were identified by the AMA RUC as potentially misvalued because the time and PE i nputs for these services were Harvard valued and these services have utilization of 500,000 service per y ear. We disagreed with the respective AMA RUCrecommended work RVUs of 0.90 and 0.70 and established interim final values of 0.80 and 0.50 instead.

We believe the AMA RUC-recommended values for these two sets of codes do not maintain the appropriate relative values within the family of duplex scans. In addition to these four codes, there are several other duplex scan codes that may fit within this family, including CPT codes: 93880 (Duplex scan of extracranial arteries; complete bilateral study), 93 882 (Duplex scan of extracranial arteries; unilateral or limited study), 93925 (Duplex scan of lower extrem ity arteries or arterial bypass grafts; complete bilateral study), 93926 (Duplex scan of lower extremit y arteries or arterial bypass grafts; unilateral or limited study), 93930 (Duplex scan of upper extremity ar teries or arterial bypass grafts; complete bilateral study), 93931 (Duplex scan of upper extremity arteri es or arterial bypass grafts; unilateral or limited study), 93970 (Duplex scan of extremity veins incl uding responses to compress ion and other maneuvers; complete bilateral study), 93971 (Duplex scan of extremity veins including responses to compression and other maneuvers; unilateral or limite d study), 93975 (Duplex scan of arte rial inflow and venous outflow of abdominal, pelvic, scrotal contents and/or retrope ritoneal organs; complete study), 93976 (Duplex scan

of arterial inflow and venous outfl ow of abdominal, pelvic, scrotal cont ents and/or retroperitoneal organs; limited study), 93978 (Duplex scan of aorta, inferi or vena cava, iliac vasculature, or bypass grafts; complete study) and 93979 (Duplex scan of aorta, infe rior vena cava, iliac vasculature, or bypass grafts; unilateral or limited study). We are concerned that the AMA RUC-recommended values for 93880 and 93882, as well as our interim final values for 93925 and 93926, do not maintain the appropriate relativity within this family and

### CMS-1600-FC 365

we are referring the entire family to the AMA RU C to assess relativity among the codes and then recommend appropriate work RVUs. We also requ est that the AMA RUC consider CPT codes 93886 (Transcranial Doppler study of the intracranial arteri es; complete study) and 93888 (Transcranial Doppler study of the intracranial arteries; limited study) in conjunction with the duplex scan codes in order to assess the relativity between and among these codes. Therefore, we will maintain the CY 2013 RVUs for CPT codes 93880 and 93882 on an interim

final basis until we receive furthe r recommendations from the AMA RUC (22) Ultrasonic Wound Assessment (CPT Code 97610) For CY 2014, the AMA RUC reviewed new CPT c ode 97610. We are contractor pricing this code for CY 2014 as recommended by the AMA RUC. A lthough the code will be contractor priced, we are designating this service as a “sometimes therapy” service. Like other “sometimes therapy” codes, when a therapist furnishes this service all outpatient therapy policies apply. (23) Interprofessional Telephone Consultative Serv ices (CPT Code 99446, 9 9447, 99448, and 99449) For CY 2014, the CPT Editorial Panel creat ed CPT codes 99446 - 99449 to describe telephone/internet consultative services. The AMA RUC-recommended work RVUs for these codes. Medicare pays for telephone consultations about a beneficiary services as a part of other services furnished to the beneficiary. Therefore, for CY 2014 we are assigning CPT c odes 99446, 99447, 99448, and 99449 a PFS procedure status indicator of B (B undled code. Payments for covered services are always bundled into payment for other services, which are not specified. If RVUs are shown, they are not used for Medicare payment. If these services are covere d, payment for them is subsumed by the payment for the services to which they are bundled (for exam ple, a telephone call from a hospital nurse regarding care of a patient).) b. Establishing Interim Final Direct PE RVUs for CY 2014 i. Background and Methodology The AMA RUC provides CMS with recommendations regarding direct PE inputs, including clinical labor, supplies, and equipment, for new, revi sed, and potentially misvalued codes. We review the

### CMS-1600-FC 366

AMA RUC-recommended direct PE inputs on a code-by- code basis, including the recommended facility PE inputs and/or nonfacility PE inputs. This review is informed by both our clinical assessment of the typical resource requirements for furnishing the service and our intention to maintain the principles of accuracy and relativity in the database. We de termine whether we agree with the AMA RUC's recommended direct PE inputs for a service or, if we disagree, we refine the PE inputs to represent inputs that better reflect our estimate of the PE resources requ ired to furnish the service in the facility and/or nonfacility settings. We also confirm that CPT cod es should have facility and/or nonfacility direct PE inputs and make changes based on our clinical judg ment and any PFS payment policies that would apply

to the code. We have accepted for CY 2014, as interim fina l and without refinement, the direct PE inputs based on the recommendations submitted by the AMA RU C for the codes listed in Table 28. For the remainder of the AMA RUC's direct PE recommendations, we have accepted the PE recommendations submitted by the AMA RUC as interim final, but with refinements. These codes and the refinements to their direct PE inputs are listed in Table 29. We note that the final CY 2014 PFS direct PE input database reflects the refined direct PE inputs that we are adopting on an interim final basis for CY 2014. That database is available under downloads for the CY 2014 PFS final rule with comment period on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Ser vice-Payment/PhysicianFeeSched/PFS-FederalRegulation-Notices.html . We also note that the PE RVUs displayed in Addenda B and C reflect the interim final values and policies described in this sec tion. All PE RVUs adopted on an interim final basis for CY 2014 are included in Addendum C and are open for comment in this final rule with comment period.

ii. Common Refinements

Table 29 details our refinements of the AMA RU C's direct PE recommendations at the code-specific level. In this section, we discuss th e general nature of some common refinements and the reasons for particular refinements.

### CMS-1600-FC 367

(a) Changes in Physician Time Some direct PE inputs are directly affected by revisions in physician time described in section II.E.3.a. of this final rule with comment period. We note that for many codes, changes in the intraservice portions of the physician time and changes in the numbe r or level of postoperative visits included in the global periods result in corresponding changes to direct PE inputs. We also note that, for a significant number of services, especially diagnostic tests, th e procedure time assumptions used in determining direct PE inputs are distinct from, and theref ore not dependent on, physician intraservice time assumptions. For these services, we do not make refineme nts to the direct PE inputs based on changes to estimated physician intraservice times. Changes in Intraservice Physician Time in the Nonfacility Setting. For most codes valued in the nonfacility setting, a portion of the clinical labor time allocated to the intraservice period reflects minutes assigned for assisting the physician with the procedure. To the extent that we are refining the times associated with the intraservice portion of such pr ocedures, we have adjusted the corresponding intraservice clinical labor minutes in the nonfacility setting. For equipment associated with the intraservice period in the nonfacility setting, we generally allocate time based on the typical number of minutes a piece of equipment is being used, and therefore, not available for use with another pa tient during that period. In gene ral, we allocate these minutes based on the description of typical clinical labor activities. To the extent that we are making changes in the

clinical labor times associated with the intraservi ce portion of procedures, we have adjusted the corresponding equipment minutes associated with the codes. Changes in the Number or Level of Post operative Office Visits in the Global Period

. For codes valued with postservice physician office visits durin g a global period, most of the clinical labor time allocated to the postservice period reflects a standard number of minutes allocated for each of those visits. To the extent that we are refining the number or level of postoperative visits , we have modified the clinical staff time in the postservice period to refl ect the change. For codes valued with postservice physician office visits during a global period, we allocate standard equipment for each of those visits. To

### CMS-1600-FC 368

the extent that we are making a change in the numbe r or level of postoperative visits associated with a code, we have adjusted the corresponding equipm ent minutes. For codes valued with postservice physician office visits during a global period, a certa in number of supply items are allocated for each of

those office visits. To the extent that we are maki ng a change in the number of postoperative visits, we have adjusted the corresponding supply item quantities associated with the codes. We note that many supply items associated with postservice physician of fice visits are allocated for each office visit (for example, a minimum multi-specialty visit pack (SA0 48) in the CY 2014 direct PE input database). For these supply items, the quantities in the direct PE inpu t database should reflect the number of office visits associated with the code's global period. However, some supply items are associated with postservice physician office visits but are only allocated once during the global peri od because they are typically used during only one of the postservice office visits (for example, pack, post-op incision care (suture) (SA054) in the direct PE input database). For these supply items, the quantities in the direct PE input database reflect that single quantity.

These refinements are reflected in the final CY 2014 PFS direct PE input database and detailed in

Table 29. (b) Equipment Minutes In general, the equipment time inputs reflect the sum of the times within the intraservice period when a clinician is using the piece of equipment, pl us any additional time the piece of equipment is not available for use for another patient due to its use dur ing the designated procedure. While some services include equipment that is typically unavailable durin g the entire clinical labor service period, certain highly technical pieces of equipment and equipment room s are less likely to be used by a clinician for all tasks associated with a service, and therefore, ar e typically available for other patients during the preservice and postservice components of the service period. We adjust those equipment times accordingly. We refer interested stakeholders to our extensive discussion of these policies in the CY 2012 PFS final rule with comment period (76 FR 73182-73 183) and in section II.E.2.b. of this final rule with comment period. We are refining the CY 2014 AMA RUC direct PE recommendations to conform

### CMS-1600-FC 369

to these equipment time policies. These refinement s are reflected in the final CY 2013 PFS direct PE input database and detailed in Table 29. (c) Moderate Sedation Inputs In the CY 2012 PFS final rule ( 76 FR 73043-73049), we finalized a standard package of direct PE inputs for services where moderate sedation is considered inherent in the procedure. We are refining the

CY 2014 AMA RUC direct PE recommendations to conf orm to these policies. These refinements are

reflected in the final CY 2013 PFS direct PE input database and detailed in Table 29. (d) Standard Minutes for Clinical Labor Tasks In general, the preservice, service period, and po stservice clinical labor minutes associated with clinical labor inputs in the direct PE input database re flect the sum of particular tasks described in the information that accompanies the recommended direct PE inputs on “PE worksheet s.” For most of these described tasks, there are a standardized number of minutes, depending on the type of procedure, its typical setting, its global period, and the other proced ures with which it is typically reported. At times,

the AMA RUC recommends a number of minutes either greater than or less than the time typically allotted for certain tasks. In those cases, CMS clinical staff reviews the deviations from the standards to assess whether they are clinically appropriate. Where the AMA RUC-recommended exceptions are not accepted, we refine the interim final direct PE inputs to match the standard times for those tasks. In addition, in cases when a service is typically billed w ith an E/M, we remove the preservice clinical labor tasks so that the inputs are not duplicative and reflect the resource costs of furnishing the typical service.

In some cases the AMA RUC recommendations include additional minutes described by a category called “other clinical activity,” or through th e addition of clinical labor tasks that are different from those previously included as standard. In th ese instances, CMS clinical staff reviews the tasks as

described in the recommendation to determine whethe r they are already incor porated into the total

number of minutes based on the standard tasks. Additi onally, CMS reviews these tasks in the context of

the kinds of tasks delineated for other services under th e PFS. For those tasks that are duplicative or not separately incorporated for other services, we do not ac cept those additional clinical labor tasks as direct

### CMS-1600-FC 370

inputs. These refinements are reflected in the fina l CY 2013 PFS direct PE input database and detailed in

Table 29. (e) New Supply and Equipment Items The AMA RUC generally recommends the use of su pply and equipment items that already exist in the direct PE input database for new, revi sed, and potentially misvalued codes. Some recommendations include supply or equipment items that are not currently in the direct PE input database. In these cases, the AMA RUC has hi storically recommended a new item be created and has facilitated CMS's pricing of that item by working with the sp ecialty societies to provide sales invoices to us. We received invoices for several new supply a nd equipment items for CY 2014. We have accepted the majority of these items and added them to the direct PE input database. However, in many cases we cannot adequately price a newly recommended item due to inadequate information. In some cases, no supporting information regarding the price of the item has been included in the recommendation to create a new item. In other cases, the supporting information does not demonstrate that the item has been purchased at the listed price (for example, price quotes instead of paid invoices). In cases where the information provided allowed us to identify clinica lly appropriate proxy items, we have used currently existing items as proxies for the newly recommended items . In other cases, we have included the item in the direct PE input database without an associated pri ce. While including the item without an associated price means that the item does not contribute to the calculation of the PE RVU for particular services, it facilitates our ability to incorporate a price once we are able to do so. (f) Recommended Items that are not Direct PE Inputs In some cases, the recommended direct PE inputs included items that are not clinical labor, disposable supplies, or medical equipment resources. We have addressed these kinds of recommendations in previous rulemaki ng and in sections II.E.2.b. and II.B.4.a. of this final rule with comment period. Refinements to adjust for these recommended inputs are reflected in the final CY 2013 PFS direct PE input database and detailed in Table 29. iii. Code-Specific Refinements

### CMS-1600-FC 371

(a) Breast Biopsy (CPT codes 19085, 19086, 19287, and 19288)

The AMA RUC submitted recommended direct PE inputs for CPT codes 19085, 19086, 19287, 19288, including suggestions to create new PE inputs for items called “20MM handpiece – MR," “vacuum line assembly,” "introducer localization set (t rocar)," and “tissue filter." CMS clinical staff

reviewed these recommended items and concluded that each of these items serve redundant clinical purposes with other biopsy supplies already included as direct PE inputs for the codes. Similarly, CMS clinical staff reviewed three newly recommended equi pment items described as “breast biopsy software," "breast biopsy device (coil)," and "lateral grid," and de termined that these items serve clinical functions to similar items already included in MR room equipm ent package (EL008). Therefore, we did not create new direct PE inputs for these seven items. These refi nements, as well as other applicable standard and common refinements for these codes, are reflected in the final CY 2014 PFS direct PE input database and

detailed in Table 29. (b) Esophagoscopy, Esophagogastroduodenoscopy and Endoscopic Retrograde Cholangiopancreatography (CPT codes 43270, 43229, and 43198) For CY 2014, the CPT Editorial Panel revised th e set of codes that describe esophagoscopy, esophagogastroduodenoscopy (EGD) and endoscopic retrograde cholangiopancreatography (ERCP).

These revisions included the addition and deletion of several codes and the development of new guidelines and coding instructions. The AMA RUC provided CMS with recommended direct PE inputs

for these services. For two codes within this family, CPT codes 43270 and 43229, the AMA RUC recommended including the supply item called "kit, probe, radiofre quency, XIi-enhanced RF probe” (SA100) as a proxy for an RF ablation catheter, as well as a new reco mmended equipment item called "radiofrequency generator (Angiodynamics)." The AMA RUC did not provide additional information regarding what portion of the RF ablation catheter might be reusable . Additionally, the recommendation did not provide information regarding why the supply item SA100 that is priced at $2,695 would be an appropriate proxy

for the RF ablation catheter. The CY 2013 codes th at would be used to report these services do not

### CMS-1600-FC 372

include these or similar items, so we believe that it would not be appropriate to assume such a significant increase in resource costs without more detail regard ing the item for which the recommended input would serve as a proxy. We note that in previo us rulemaking (77 FR 690 31) we have addressed recommendations for other codes that also suggested using this expensive disposable supply as a proxy input. For these other services, we created a proxy equipment item instead of a proxy supply item, pending the submission of additional informati on regarding the newly recommended item.

We also note that the AMA RUC recommendation did not include adequate information that would allow us to price the newly recomme nded item called "'radi ofrequency generator (Angiodynamics)." To incorporate the best estimate of resource costs for these items for these new codes for CY 2014, we followed the precedents set in previo us rulemaking and created a new equipment item to serve as a proxy for the “RF ablation catheter,” and used a currently existing radiofrequency generator equipment item (EQ214) as a proxy item pending the submission of additional information regarding

these items. For another new code in the family, CPT code 43198, the AMA RUC recommended including a disposable supply item called “endoscopic biopsy forc eps” (SD066). However, additional information included with the recommendation suggested that a reusab le biopsy forceps is typically used in furnishing the service. Therefore, we did not incorporate the di sposable forceps in the direct PE input database. These refinements, as well as other applicable st andard and common refinements for these codes,

are reflected in the final CY 2014 PFS direct PE input database and detailed in Table 29. (c) Dilation of Esophagus (CPT codes 43450 and 43453) The AMA RUC recommended direct PE input updates for CTP codes 43450 and 43453. The recommendation included a new item listed as a supply called “esophageal bougies.” We note that we did not receive an invoice or additional description of th is item and, based on CMS clinical staff clinical review, we believe the functionality of this kind of item can be accomplished through the use of a reusable piece of equipment. Therefore, we cr eated a new equipment item called “esophageal bougies, set, reusable.” Once we receive appropriate prici ng information regarding th e new item, we will update

### CMS-1600-FC 373

the price in the direct PE input database. This re finement and other appli cable standard and common

refinements for these codes are reflected in the fi nal CY 2014 PFS direct PE in put database and detailed

in Table 29. (d) MRI of Brain (CPT codes 70551, 70552, and 70553) The AMA RUC recommended updated direct PE in puts for a series of codes that describe magnetic resonance imaging (MRI) of the brain. We note the AMA RUC recommended that the typical length of time it takes for the MRI technician to acqui re images is equal to the time it took in 2002, when the PE inputs for the codes were last evaluated. When reviewing the direct PE inputs for this code , CMS clinical staff concluded that there should be no significant difference between the assumed time to acquire images for MRI of the brain and MRI of the spine; therefore, we have ad justed the direct PE inputs accordingly. This refinement and other applicable standard and common refinements for these codes are reflected in the final CY 2014 PFS direct PE input database and detailed in Table 29. (e) Selective Catheter Placement (CPT codes 36245 and 75726) The AMA RUC submitted new direct PE input s for CPT code 36245 (Selective catheter placement, arterial system; each first order abdominal, pelvic, or lower extremity artery branch, within a vascular family). We have reviewed the recommende d direct PE inputs for this service and made the applicable standard and common refinements which are reflected in the final CY 2014 PFS direct PE input database and detailed in Table 29. However, we note that the review of CPT code 36245 was

initiated based on the identification of the code thr ough two misvalued code screens. One of these was the screen that identifies codes reported together at least 75 percent of the time. As the RUC noted in its recommendation, CPT 36245 may be reported with a number of different radi ologic supervision and interpretation codes including 75726 (Angiography, visceral, selective or supraselective (with or without flush aortogram), radiological supervision and in terpretation). The AMA RUC recommendation stated that, because these code combinations were valued as individual component codes, no potential for duplication of physician work exists. The recomme nded direct PE inputs for CPT 36245 did not address

### CMS-1600-FC 374

whether or not the direct PE inputs for CPT code 75726 should be updated given that it is typically reported with CPT code 36245. The current direct PE inputs for 75726 include 73 clinical labor minutes for “assist physician in performing procedure.” This time matches the pr ecise number of minutes assumed for the same task for CPT code 36245 in the existing direct PE inputs. The AMA RUC has recommended changing the amount of time considered typical for that task from 73 minutes to 45 minutes and we are accepting that change, without refinement, on an interim final basi s for CY 2014. Given that these codes are typically reported together and the underlying procedure time assumption used in valuing 75726 is dependent on the assumed times for 36245, we believe it is appropria te to make a corresponding change to 75726 on an

interim final basis to reflect the best estimate of resources for these services which are frequently furnished together. This change is reflected in the final CY 2014 PFS direct PE input database and

detailed in Table 29. (g) Respiratory motion management simulation (CPT code 77293) The AMA RUC submitted direct PE inputs recomm endations for CPT code 77293 (Respiratory motion management simulation). Among these was the recommendation to create a new equipment item called "virtual simulation package." However, the information that accompanied the recommendation included a price quote for the new item instead of a copy of paid invoice. We believe that the currently existing item “radiation virtual simulation system” (E R057) will serve as an appropriate proxy for the new item pending our receipt of additional inform ation regarding the newly recommended item. This refinement and other applicable standard and common refinements for these codes are reflected in the final CY 2014 PFS direct PE input data base and detailed in Table 29. (h) Stereotactic Body Radiation Therapy (CPT code 77373) The AMA RUC recommended updated direct PE in puts for CPT code 77373 (Stereotactic body radiation therapy, treatment delivery, per fraction to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions). We note that we previously established final direct PE inputs for this code in the CY 2013 PFS final rule with comment period (77 FR 68922) in response to direct PE inputs

### CMS-1600-FC 375

we proposed in the CY 2013 PFS proposed rule (77 FR 4474 3). In finalizing the direct PE inputs for this code, we explained that we were including the equi pment item called “radiation treatment vault” (ER056) based on public comment, and noting that we had questions regarding whether the item is appropriately categorized as equipment within the established PE methodology. The AMA RUC recommendations did not include the “radiation treatment vault” (ER056) for CPT 77373. Because we intend to address that issue in future rulemaking, we believe that we shoul d continue to include the item as a direct PE input for CY 2014. This refinement and other applicable standard and common refinements for these codes are

reflected in the final CY 2014 PFS direct PE input database and detailed in Table 29. 

### (i) Immunohistochemistry (CPT codes 88342 and 88343 and HCPCS codes G0461 and G0462 The AMA RUC recommended direct PE inputs for revised CPT code 88342 and new CPT code 88343. We direct the reader to section II.E.3 of this final rule with comment period. There, we discuss

our decision for CY 2014 to use HCPCS codes G0461 and G0462 for Medicare services instead of reporting the CPT codes describing immunohistoc hemistry services and to use the AMA RUC recommended values for the CPT codes in establishing interim final values for the HCPCS codes. We based the interim final direct PE inputs for G0461 and G0462 on the recommended inputs for CPT codes 88342 and 88343, therefore the standard and common refinements to the recommended direct PE inputs for these CPT codes are detailed in Table 29 as the inpu ts for G0461 and G0462. Likewise, the interim final direct PE inputs for G0461 and G0462 appear in the final CY 2014 PFS direct PE input database. (j) Anogenital Examination with Colposcopic Ma gnification in Childhood for Suspected Trauma (CPT code 99170) The AMA RUC recommended updated direct PE inputs for CPT code 99170. As part of that recommendation, the AMA RUC recommended that we cr eate a new clinical labor type called "Child Life Specialist" to be included in the direct PE input database for this particular service. The

recommendation also contained additional informatio n that might facilitate the development of an appropriate cost/minute for this new clinical labor t ype. After reviewing that information, we conclude that the resource costs for the new clinical labor type are very similar to the costs associated with the

### CMS-1600-FC 376

existing nurse blend clinical labor type (L037D). Therefore, we have created a new clinical labor category called “Child Life Specialist” (L037E) with a rate per minute crosswalked from the existing labor type L037D. We also note that the direct PE input recommendation for this code did not conform to the usual

format. The PE worksheet included minutes for the ne w clinical labor type but instead of assigning minutes to specified clinical labor tasks, the worksh eet referenced a narrative description of the tasks for the clinical labor type in the preservice, intra-, and postservice periods. This format did not limit our clinical staff from reviewing the recommendation, but it does not allow us to display refinements for particular tasks in Table 29. Instead, the refine ments to the recommended aggregate number of minutes for each time component appear in the table along with other applicable standard and common refinements to the recommended direct PE inputs.

TABLE 28: CY 2014 Interim Final Codes with Direct PE Input Recommendations Accepted without Refinement

CPT Code CPT Code Description 17003 Destruct premalg les 2-14 17311 Mohs 1 stage h/n/hf/g 17312 Mohs addl stage 17313 Mohs 1 stage t/a/l 17314 Mohs addl stage t/a/l 17315 Mohs surg addl block 19081 Bx breast 1st lesion strtctc 19082 Bx breast add lesion strtctc 19083 Bx breast 1st lesion us imag 19084 Bx breast add lesion us imag 19283 Perq dev breast 1st strtctc 19284 Perq dev breast add strtctc 19285 Perq dev breast 1st us imag 23333 Remove shoulder fb deep 23334 Shoulder prosthesis removal 23335 Shoulder prosthesis removal 24160 Remove elbow joint implant

### CMS-1600-FC 377

CPT Code CPT Code Description 24164 Remove radius head implant 27130 Total hip arthroplasty 27236 Treat thigh fracture 27446 Revision of knee joint 27447 Total knee arthroplasty 27466 Lengthening of thigh bone 31239 Nasal/sinus endoscopy surg 31240 Nasal/sinus endoscopy surg 33282 Implant pat-active ht record 33284 Remove pat-active ht record 35301 Rechanneling of artery 37217 Stent placemt retro carotid 37239 Open/perq place stent ea add 43191 Esophagoscopy rigid trnso dx 43192 Esophagoscp rig trnso inject 43193 Esophagoscp rig trnso biopsy 43194 Esophagoscp rig trnso rem fb 43195 Esophagoscopy rigid balloon 43196 Esophagoscp guide wire dilat 43204 Esoph scope w/sclerosis inj 43205 Esophagus endoscopy/ligation 43211 Esophagoscop mucosal resect 43212 Esophagoscop stent placement 43214 Esophagosc dilate balloon 30 43233 Egd balloon dil esoph30 mm/> 43237 Endoscopic us exam esoph 43238 Egd us fine needle bx/aspir 43240 Egd w/transmural drain cyst 43241 Egd tube/cath insertion 43242 Egd us fine needle bx/aspir 43243 Egd injection varices 43244 Egd varices ligation 43246 Egd place gastrostomy tube 43251 Egd remove lesion snare 43253 Egd us transmural injxn/mark 43254 Egd endo mucosal resection 43257 Egd w/thrml txmnt gerd 43259 Egd us exam duodenum/jejunum

### CMS-1600-FC 378

CPT Code CPT Code Description 43260 Ercp w/specimen collection 43261 Endo cholangiopancreatograph 43262 Endo cholangiopancreatograph 43263 Ercp sphincter pressure meas 43264 Ercp remove duct calculi 43265 Ercp lithotripsy calculi 43266 Egd endoscopic stent place 43273 Endoscopic pancreatoscopy 43274 Ercp duct stent placement 43275 Ercp remove forgn body duct 43276 Ercp stent exchange w/dilate 43277 Ercp ea duct/ampulla dilate 43278 Ercp lesion ablate w/dilate 50360 Transplantation of kidney 52356 Cysto/uretero w/lithotripsy 62310 Inject spine cerv/thoracic 62311 Inject spine lumbar/sacral 62318 Inject spine w/cath crv/thrc 62319 Inject spine w/cath lmb/scrl 63047 Remove spine lamina 1 lmbr 63048 Remove spinal lamina add-on 64643 Chemodenerv 1 extrem 1-4 ea 64645 Chemodenerv 1 extrem 5/> ea 66183 Insert ant drainage device 69210 Remove impacted ear wax uni 77001 Fluoroguide for vein device 77002 Needle localization by xray 77003 Fluoroguide for spine inject 77280 Set radiation therapy field 77285 Set radiation therapy field 77290 Set radiation therapy field 77295 3-d radiotherapy plan 77301 Radiotherapy dose plan imrt 77336 Radiation physics consult 77338 Design mlc device for imrt 77372 Srs linear based 88112 Cytopath cell enhance tech 90839 Psytx crisis initial 60 min

### CMS-1600-FC 379

CPT Code CPT Code Description 90840 Psytx crisis ea addl 30 min 90875 Psychophysiological therapy 91065 Breath hydrogen/methane test 92521 Evaluation of speech fluency 92522 Evaluate speech production 92523 Speech sound lang comprehen 92524 Behavral qualit analys voice 93000 Electrocardiogram complete 93005 Electrocardiogram tracing 93010 Electrocardiogram report 95928 C motor evoked uppr limbs 95929 C motor evoked lwr limbs 96365 Ther/proph/diag iv inf init 96366 Ther/proph/diag iv inf addon 96367 Tx/proph/dg addl seq iv inf 96368 Ther/diag concurrent inf 96413 Chemo iv infusion 1 hr 96415 Chemo iv infusion addl hr 96417 Chemo iv infus each addl seq 98940 Chiropract manj 1-2 regions 98941 Chiropract manj 3-4 regions 98942 Chiropractic manj 5 regions 98943 Chiropract manj xtrspinl 1/>

TABLE 29: CY 2014 Interim Final Codes with Direct PE Input Recommendations Accepted with Refinements

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EF018 stretcher NF 120 0 Nonstandard input for Moderate Sedation 10030 Guide cathet fluid drainage

EF027 table, instrument,

mobile NF 159 152 Standard input for Moderate Sedation

### CMS-1600-FC 380

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 159 152 Standard input for Moderate Sedation

EQ032 IV infusion pump NF 159 152 Standard input for Moderate Sedation

L037D RN/LPN/MTA NF Circulating throughout procedure (25%) 8 7 Conforms to proportion ate allocation of intraservic e time among clinical labor types

ED004 camera, digital (6 mexapixel) NF 22 13 Refined equipment time to conform to changes in clinical labor time

EF031 table, power NF 46 40 Refined equipment time to conform to changes in clinical labor time

EQ093 cryosurgery equipment (for liquid nitrogen) NF 22 13 Refined equipment time to conform to changes in clinical labor time 17000 Destruct premalg

lesion

EQ168 light, exam NF 46 40 Refined equipment time to conform to changes in clinical labor time

### CMS-1600-FC 381

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

SA048 pack, minimum multi-specialty visit NF 1 2 CMS clinical review

SA048 pack, minimum multi-specialty visit F 0 1 CMS clinical review

ED004 camera, digital (6 mexapixel) NF 41 30 Refined equipment time to conform to changes in clinical labor time

EQ093 cryosurgery equipment (for liquid nitrogen) NF 41 30 Refined equipment time to conform to changes in clinical labor time

SA048 pack, minimum multi-specialty visit NF 1 2 CMS clinical review 17004 Destroy premal lesions

15/>

SA048 pack, minimum multi-specialty visit F 0 1 CMS clinical review

S 20MM handpiece - MR NF 1 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs 19085 Bx breast 1st lesion mr imag

S vacuum line assembly NF 1 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

### CMS-1600-FC 382

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

S introducer localization set (trocar) NF 1 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

S tissue filter NF 1 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

E breast biopsy software NF 54 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

E breast biopsy device (coil) NF 54 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

E lateral grid NF 54 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

### CMS-1600-FC 383

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

S 20MM handpiece - MR NF 1 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

S vacuum line assembly NF 1 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

S introducer localization set (trocar) NF 1 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

S tissue filter NF 1 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs 19086 Bx breast add lesion mr

imag

E breast biopsy software NF 43 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

### CMS-1600-FC 384

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

E breast biopsy device (coil) NF 43 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

E lateral grid NF 43 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

ED025 film processor, wet NF 9 5 Refined equipment time to conform to changes in clinical labor time

ER029 film alternator (motorized film viewbox) NF 9 5 CMS clinical review 19281 Perq device breast 1st

imag

L043A Mammography Technologist NF Process images, complete data sheet,

present images and data to the interpreting physician 9 5 CMS clinical review

19282 Perq device breast ea

imag ED025 film processor, wet NF 9 5 Refined equipment time to conform to changes in clinical labor time

### CMS-1600-FC 385

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

ER029 film alternator (motorized film viewbox) NF 9 5 Refined equipment time to conform to changes in clinical labor time

L043A Mammography Technologist NF Other Clinical Activity (Service) 9 5 CMS clinical review

19286 Perq dev breast add us imag L043A Mammography Technologist NF Assist physician in performing procedure 19 14 Conformin g to physician time

S 20MM handpiece - MR NF 1 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

S vacuum line assembly NF 1 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs 19287 Perq dev breast 1st mr guide

S introducer localization set (trocar) NF 1 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

### CMS-1600-FC 386

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

S tissue filter NF 1 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

E breast biopsy software NF 46 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

E breast biopsy device (coil) NF 46 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

E lateral grid NF 46 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

19288 Perq dev breast add mr guide S 20MM handpiece - MR NF 1 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

### CMS-1600-FC 387

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

S vacuum line assembly NF 1 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

S introducer localization set (trocar) NF 1 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

S tissue filter NF 1 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

E breast biopsy software NF 35 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

E breast biopsy device (coil) NF 35 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

### CMS-1600-FC 388

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

E lateral grid NF 35 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

EF031 table, power F 90 63 Refined equipment time to conform to changes in clinical labor time

EQ168 light, exam F 90 63 Refined equipment time to conform to changes in clinical labor time

L037D RN/LPN/MTA F Total Office Visit Time 90 63 Conformin g to physician time 23333 Remove shoulder fb deep

SA048 pack, minimum multi-specialty visit F 3 2 Conformin g to physician time

L037D RN/LPN/MTA F Post Service Period 99 108 Conformin g to physician time

27130 Total hip arthropla sty EF031 table, power F 99 108 Refined equipment time to conform to changes in clinical labor time

27447 Total knee arthropla sty L037D RN/LPN/MTA F Post Service Period 99 108 Conformin g to physician time

### CMS-1600-FC 389

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EF031 table, power F 99 108 Refined equipment time to conform to changes in clinical labor time

31237 Nasal/sin us endoscop

y surg L037D RN/LPN/MTA NF Monitor pt. following service/che ck tubes, monitors, drains 15 5 CMS clinical review

31238 Nasal/sin us endoscop

y surg L037D RN/LPN/MTA NF Monitor pt. following service/che ck tubes, monitors, drains 15 5 CMS clinical review

33366 Trcath replace aortic valve L037D RN/LPN/MTA F Coordinate pre-surgery services 40 20 CMS clinical review; refinement reflects standard preservice times

36245 Ins cath abd/l-ext

art 1st EF018 stretcher NF 240 0 Nonstandard input for Moderate Sedation

EF018 stretcher NF 240 0 Nonstandard input for Moderate Sedation 37236 Open/per q place stent 1st

EF027 table, instrument,

mobile NF 347 332 Standard input for Moderate Sedation

### CMS-1600-FC 390

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 347 332 Standard input for Moderate Sedation

EQ032 IV infusion pump NF 347 332 Standard input for Moderate Sedation

S Balloon expandable NF 1 0 CMS clinical review; input already exists

SD152 catheter, balloon, PTA NF 0 1 CMS clinical review; input already exists

S Balloon expandable NF 1 0 CMS clinical review; input already exists 37237 Open/per q place stent ea

add SD152 catheter, balloon, PTA NF 0 1 CMS clinical review; input already exists

EF018 stretcher NF 180 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 257 302 Standard input for Moderate Sedation 37238 Open/per q place

stent same

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 257 302 Standard input for Moderate Sedation

### CMS-1600-FC 391

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ032 IV infusion pump NF 257 302 Standard input for Moderate Sedation

EF018 stretcher NF 180 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 287 272 Standard input for Moderate Sedation

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 287 272 Standard input for Moderate Sedation

EQ032 IV infusion pump NF 287 272 Standard input for Moderate Sedation 37241 Vasc embolize /occlude venous

L037D RN/LPN/MTA NF Circulating throughout procedure (25%) 23 22 Conforms to proportion ate allocation of intraservic e time among clinical labor types

EF018 stretcher NF 240 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 357 342 Standard input for Moderate Sedation 37242 Vasc embolize /occlude

artery

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 357 342 Standard input for Moderate Sedation

### CMS-1600-FC 392

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ032 IV infusion pump NF 357 342 Standard input for Moderate Sedation

EF018 stretcher NF 240 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 377 362 Standard input for Moderate Sedation

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 377 362 Standard input for Moderate Sedation 37243 Vasc embolize /occlude

organ

EQ032 IV infusion pump NF 377 362 Standard input for Moderate Sedation

EF018 stretcher NF 240 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 347 332 Standard input for Moderate Sedation

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 347 332 Standard input for Moderate Sedation 37244 Vasc embolize /occlude

bleed

EQ032 IV infusion pump NF 347 332 Standard input for Moderate Sedation

### CMS-1600-FC 393

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

L037D RN/LPN/MTA NF Circulating throughout procedure (25%) 23 22 Conforms to proportion ate allocation of intraservic e time among clinical labor types

ED036 video printer, color (Sony medical grade) NF 15 39 Refined equipment time to conform to established policies for technical equipment

EF008 chair with headrest, exam, reclining NF 15 39 Refined equipment time to conform to established policies for technical equipment

EF015 mayo stand NF 15 39 Refined equipment time to conform to established policies for technical equipment 43197 Esophag oscopy flex dx brush

EQ170 light, fiberopticheadlight wsource NF 15 39 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 394

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ234 suction and pressure cabinet,

ENT (SMR) NF 15 39 Refined equipment time to conform to established policies for technical equipment

ER095 transnasal esophagoscope

80K series NF 15 66 Refined equipment time to conform to established policies for technical equipment

ES026 video add-on camera system

w-monitor (endoscopy) NF 15 39 Refined equipment time to conform to established policies for technical equipment

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 15 39 Refined equipment time to conform to established policies for technical equipment

L026A Medical/Technic al Assistant NF Clean Surgical Instrument Package 10 0 Standardiz ed time input; surgical instrument package not included

43198 Esophag osc flex

trnsn biopsy ED036 video printer, color (Sony medical grade) NF 20 46 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 395

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EF008 chair with headrest, exam, reclining NF 20 46 Refined equipment time to conform to established policies for technical equipment

EF015 mayo stand NF 20 46 Refined equipment time to conform to established policies for technical equipment

EQ170 light, fiberopticheadlight wsource NF 20 46 Refined equipment time to conform to established policies for technical equipment

EQ234 suction and pressure cabinet,

ENT (SMR) NF 20 46 Refined equipment time to conform to established policies for technical equipment

ER095 transnasal esophagoscope

80K series NF 20 73 Refined equipment time to conform to established policies for technical equipment

ES026 video add-on camera system

w-monitor (endoscopy) NF 20 46 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 396

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 20 46 Refined equipment time to conform to established policies for technical equipment

L026A Medical/Technic al Assistant NF Clean Surgical Instrument Package 10 0 Standardiz ed time input

SD066 endoscopic biopsy forceps NF 1 0 CMS clinical review

EF018 stretcher NF 73 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 29 77 Standard input for Moderate Sedation

EF031 table, power NF 29 43 Refined equipment time to conform to established policies for technical equipment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 52 77 Standard input for Moderate Sedation 43200 Esophag oscopy flexible brush

EQ032 IV infusion pump NF 52 77 Standard input for Moderate Sedation

### CMS-1600-FC 397

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ235 suction machine (Gomco) NF 29 43 Refined equipment time to conform to established policies for technical equipment

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 29 43 Refined equipment time to conform to established policies for technical equipment

ES034 videoscope, gastroscopy NF 59 70 Refined equipment time to conform to established policies for technical equipment SD009 canister, suction NF 2 1 CMS clinical review

EF018 stretcher NF 76 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 32 80 Standard input for Moderate Sedation

EF031 table, power NF 32 46 Refined equipment time to conform to changes in clinical labor time 43201 Esoph scope w/submu cous inj

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 55 80 Standard input for Moderate Sedation

### CMS-1600-FC 398

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ032 IV infusion pump NF 55 80 Standard input for Moderate Sedation

EQ235 suction machine (Gomco) NF 32 46 Refined equipment time to conform to changes in clinical labor time

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 32 46 Refined equipment time to conform to changes in clinical labor time

ES034 videoscope, gastroscopy NF 62 73 Refined equipment time to conform to changes in clinical labor time

L037D RN/LPN/MTA NF Assist physician in performing procedure 18 15 Conformin g to physician time

L051A RN NF Monitor patient during Moderate Sedation 18 15 Conformin g to physician time

SC079 needle, micropigmentati on (tattoo) NF 1 0 CMS clinical review

SD009 canister, suction NF 2 1 CMS clinical review

SL035 cup, biopsyspecimen nonsterile 4oz NF 1 0 CMS clinical review

### CMS-1600-FC 399

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EF018 stretcher NF 78 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 34 82 Standard input for Moderate Sedation

EF031 table, power NF 34 48 Refined equipment time to conform to changes in clinical labor time

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 57 82 Standard input for Moderate Sedation

EQ032 IV infusion pump NF 57 82 Standard input for Moderate Sedation

EQ235 suction machine (Gomco) NF 34 48 Refined equipment time to conform to changes in clinical labor time

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 34 48 Refined equipment time to conform to changes in clinical labor time 43202 Esophag oscopy

flex biopsy

ES034 videoscope, gastroscopy NF 64 75 Refined equipment time to conform to changes in clinical labor time

### CMS-1600-FC 400

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

L037D RN/LPN/MTA NF Assist physician in performing procedure 20 15 Conformin g to physician time

L051A RN NF Monitor patient during Moderate Sedation 20 15 Conformin g to physician time

SD009 canister, suction NF 2 1 CMS clinical review

EF018 stretcher NF 91 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 47 92 Standard input for Moderate Sedation

EF031 table, power NF 47 61 Refined equipment time to conform to established policies for technical equipment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 70 92 Standard input for Moderate Sedation

EQ032 IV infusion pump NF 70 92 Standard input for Moderate Sedation 43206 Esoph optical endomicr

oscopy

EQ235 suction machine (Gomco) NF 47 61 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 401

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ355 optical endomicroscope

processor unit system NF 77 61 Refined equipment time to conform to established policies for technical equipment

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 47 61 Refined equipment time to conform to established policies for technical equipment

ES034 videoscope, gastroscopy NF 77 88 Refined equipment time to conform to established policies for technical equipment SD009 canister, suction NF 2 1 CMS clinical review

EF018 stretcher NF 103 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 59 107 Standard input for Moderate Sedation

EF031 table, power NF 59 73 Refined equipment time to conform to established policies for technical equipment 43213 Esophag oscopy

retro balloon

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 82 107 Standard input for Moderate Sedation

### CMS-1600-FC 402

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ032 IV infusion pump NF 82 107 Standard input for Moderate Sedation

EQ235 suction machine (Gomco) NF 59 73 Refined equipment time to conform to established policies for technical equipment

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 59 73 Refined equipment time to conform to established policies for technical equipment

ES034 videoscope, gastroscopy NF 89 100 Refined equipment time to conform to established policies for technical equipment

EF018 stretcher NF 78 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 34 82 Standard input for Moderate Sedation 43215 Esophag oscopy

flex remove fb

EF031 table, power NF 34 48 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 403

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 57 82 Standard input for Moderate Sedation

EQ032 IV infusion pump NF 57 82 Standard input for Moderate Sedation

EQ235 suction machine (Gomco) NF 34 48 Refined equipment time to conform to established policies for technical equipment

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 34 48 Refined equipment time to conform to established policies for technical equipment

ES034 videoscope, gastroscopy NF 64 75 Refined equipment time to conform to established policies for technical equipment SD009 canister, suction NF 2 1 CMS clinical review

EF018 stretcher NF 80 0 Nonstandard input for Moderate Sedation 43216 Esophag oscopy lesion removal

EF027 table, instrument,

mobile NF 36 84 Standard input for Moderate Sedation

### CMS-1600-FC 404

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EF031 table, power NF 36 50 Refined equipment time to conform to established policies for technical equipment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 59 84 Standard input for Moderate Sedation

EQ032 IV infusion pump NF 59 84 Standard input for Moderate Sedation

EQ113 electrosurgical generator, gastrocautery NF 36 50 Refined equipment time to conform to established policies for technical equipment

EQ235 suction machine (Gomco) NF 36 50 Refined equipment time to conform to established policies for technical equipment

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 36 50 Refined equipment time to conform to established policies for technical equipment

ES034 videoscope, gastroscopy NF 66 77 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 405

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

SD009 canister, suction NF 2 1 CMS clinical review

EF018 stretcher NF 88 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 44 92 Standard input for Moderate Sedation

EF031 table, power NF 44 58 Refined equipment time to conform to established policies for technical equipment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 67 92 Standard input for Moderate Sedation

EQ032 IV infusion pump NF 67 92 Standard input for Moderate Sedation

EQ113 electrosurgical generator, gastrocautery NF 44 58 Refined equipment time to conform to established policies for technical equipment 43217 Esophag oscopy snare les

remv

EQ235 suction machine (Gomco) NF 44 58 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 406

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 44 58 Refined equipment time to conform to established policies for technical equipment

ES034 videoscope, gastroscopy NF 74 85 Refined equipment time to conform to established policies for technical equipment SD009 canister, suction NF 2 1 CMS clinical review

EF018 stretcher NF 78 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 34 82 Standard input for Moderate Sedation

EF031 table, power NF 34 48 Refined equipment time to conform to established policies for technical equipment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 57 82 Standard input for Moderate Sedation 43220 Esophag oscopy balloon <30mm

EQ032 IV infusion pump NF 57 82 Standard input for Moderate Sedation

### CMS-1600-FC 407

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ235 suction machine (Gomco) NF 34 48 Refined equipment time to conform to established policies for technical equipment

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 34 48 Refined equipment time to conform to established policies for technical equipment

ES034 videoscope, gastroscopy NF 64 75 Refined equipment time to conform to established policies for technical equipment SD009 canister, suction NF 2 1 CMS clinical review

SD019 catheter, balloon, ureteral-GI (strictures) NF SD205 SD019 Supply proxy change due to CMS clinical review

SD090 guidewire, STIFF NF 1 0 CMS clinical review

SL035 cup, biopsyspecimen nonsterile 4oz NF 1 0 CMS clinical review

EF018 stretcher NF 83 0 Nonstandard input for Moderate Sedation 43226 Esoph endoscop y dilation

EF027 table, instrument,

mobile NF 39 87 Standard input for Moderate Sedation

### CMS-1600-FC 408

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EF031 table, power NF 39 53 Refined equipment time to conform to established policies for technical equipment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 62 87 Standard input for Moderate Sedation

EQ032 IV infusion pump NF 62 87 Standard input for Moderate Sedation

EQ235 suction machine (Gomco) NF 39 53 Refined equipment time to conform to established policies for technical equipment

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 39 53 Refined equipment time to conform to established policies for technical equipment

ES034 videoscope, gastroscopy NF 69 80 Refined equipment time to conform to established policies for technical equipment

L037D RN/LPN/MTA NF Clean Surgical Instrument Package 0 10 Standardiz ed time input

SD009 canister, suction NF 2 1 CMS clinical review

### CMS-1600-FC 409

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

SL035 cup, biopsyspecimen nonsterile 4oz NF 1 0 CMS clinical review

EF018 stretcher NF 88 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 44 92 Standard input for Moderate Sedation

EF031 table, power NF 44 58 Refined equipment time to conform to established policies for technical equipment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 67 92 Standard input for Moderate Sedation

EQ032 IV infusion pump NF 67 92 Standard input for Moderate Sedation

EQ113 electrosurgical generator, gastrocautery NF 44 58 Refined equipment time to conform to established policies for technical equipment 43227 Esophag oscopy control bleed

EQ235 suction machine (Gomco) NF 44 58 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 410

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 44 58 Refined equipment time to conform to established policies for technical equipment

ES034 videoscope, gastroscopy NF 74 85 Refined equipment time to conform to established policies for technical equipment SD009 canister, suction NF 2 1 CMS clinical review

EF018 stretcher NF 103 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 59 107 Standard input for Moderate Sedation

EF031 table, power NF 59 73 Refined equipment time to conform to established policies for technical equipment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 82 107 Standard input for Moderate Sedation 43229 Esophag oscopy lesion ablate

EQ032 IV infusion pump NF 82 107 Standard input for Moderate Sedation

### CMS-1600-FC 411

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ113 electrosurgical generator, gastrocautery NF 59 73 Refined equipment time to conform to established policies for technical equipment

EQ214 radiofrequency generator (NEURO) NF 59 73 CMS clinical review; see discussion in section II.D.3.b. of this final rule

EQ235 suction machine (Gomco) NF 59 73 Refined equipment time to conform to established policies for technical equipment

EQ356 kit, probe, radiofrequency, XIi-enhanced RF probe (proxy for catheter, RF

ablation, endoscopic) NF 0 73 CMS clinical review; see discussion in section II.D.3.b. of this final rule

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 59 73 Refined equipment time to conform to established policies for technical equipment

ES034 videoscope, gastroscopy NF 89 100 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 412

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

SA100 kit, probe, radiofrequency, XIi-enhanced RF probe NF 1 0 CMS clinical review

EF018 stretcher NF 103 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 59 107 Standard input for Moderate Sedation

EF031 table, power NF 59 73 Refined equipment time to conform to changes in clinical labor time

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 82 107 Standard input for Moderate Sedation

EQ032 IV infusion pump NF 82 107 Standard input for Moderate Sedation

EQ235 suction machine (Gomco) NF 59 73 Refined equipment time to conform to changes in clinical labor time 43231 Esophag oscop ultrasoun

d exam

ER094 endoscopic ultrasound processor NF 59 73 Refined equipment time to conform to changes in clinical labor time

### CMS-1600-FC 413

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 59 73 Refined equipment time to conform to changes in clinical labor time

ES038 videoscope, endoscopic ultrasound NF 89 100 Refined equipment time to conform to changes in clinical labor time

L037D RN/LPN/MTA NF Assist physician in performing procedure 45 30 Conformin g to physician time

L051A RN NF Monitor patient during Moderate Sedation 45 30 Conformin g to physician time

SD009 canister, suction NF 2 1 CMS clinical review

SL035 cup, biopsyspecimen nonsterile 4oz NF 1 0 CMS clinical review

EF018 stretcher NF 118 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 74 122 Standard input for Moderate Sedation 43232 Esophag oscopy

w/us needle bx

EF031 table, power NF 74 88 Refined equipment time to conform to changes in clinical labor time

### CMS-1600-FC 414

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 97 122 Standard input for Moderate Sedation

EQ032 IV infusion pump NF 97 122 Standard input for Moderate Sedation

EQ235 suction machine (Gomco) NF 74 88 Refined equipment time to conform to changes in clinical labor time

ER094 endoscopic ultrasound processor NF 74 88 Refined equipment time to conform to changes in clinical labor time

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 74 88 Refined equipment time to conform to changes in clinical labor time

ES038 videoscope, endoscopic ultrasound NF 104 115 Refined equipment time to conform to changes in clinical labor time

L037D RN/LPN/MTA NF Assist physician in performing procedure 60 45 Conformin g to physician time

L051A RN NF Monitor patient during Moderate Sedation 60 45 Conformin g to physician time

### CMS-1600-FC 415

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

SD009 canister, suction NF 2 1 CMS clinical review

EF018 stretcher NF 73 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 29 77 Standard input for Moderate Sedation

EF031 table, power NF 29 43 Refined equipment time to conform to established policies for technical equipment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 52 77 Standard input for Moderate Sedation

EQ032 IV infusion pump NF 52 77 Standard input for Moderate Sedation

EQ235 suction machine (Gomco) NF 29 43 Refined equipment time to conform to established policies for technical equipment 43235 Egd diagnosti c brush wash

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 29 43 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 416

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

ES034 videoscope, gastroscopy NF 59 70 Refined equipment time to conform to established policies for technical equipment SD009 canister, suction NF 2 1 CMS clinical review

EF018 stretcher NF 78 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 34 82 Standard input for Moderate Sedation

EF031 table, power NF 34 48 Refined equipment time to conform to established policies for technical equipment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 57 82 Standard input for Moderate Sedation

EQ032 IV infusion pump NF 57 82 Standard input for Moderate Sedation 43236 Uppr gi scope w/submu

c inj

EQ235 suction machine (Gomco) NF 34 48 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 417

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 34 48 Refined equipment time to conform to established policies for technical equipment

ES034 videoscope, gastroscopy NF 64 75 Refined equipment time to conform to established policies for technical equipment SD009 canister, suction NF 2 1 CMS clinical review

EF018 stretcher NF 73 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 29 77 Standard input for Moderate Sedation

EF031 table, power NF 29 43 Refined equipment time to conform to established policies for technical equipment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 52 77 Standard input for Moderate Sedation 43239 Egd biopsy single/m ultiple

EQ032 IV infusion pump NF 52 77 Standard input for Moderate Sedation

### CMS-1600-FC 418

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ235 suction machine (Gomco) NF 29 43 Refined equipment time to conform to established policies for technical equipment

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 29 43 Refined equipment time to conform to established policies for technical equipment

ES034 videoscope, gastroscopy NF 59 70 Refined equipment time to conform to established policies for technical equipment SD009 canister, suction NF 2 1 CMS clinical review

EF018 stretcher NF 81 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 37 85 Standard input for Moderate Sedation

EF031 table, power NF 37 51 Refined equipment time to conform to established policies for technical equipment 43245 Egd dilate stricture

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 60 85 Standard input for Moderate Sedation

### CMS-1600-FC 419

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ032 IV infusion pump NF 60 85 Standard input for Moderate Sedation

EQ235 suction machine (Gomco) NF 37 51 Refined equipment time to conform to established policies for technical equipment

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 37 51 Refined equipment time to conform to established policies for technical equipment

ES034 videoscope, gastroscopy NF 67 78 Refined equipment time to conform to established policies for technical equipment SD009 canister, suction NF 2 1 CMS clinical review

EF018 stretcher NF 88 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 44 92 Standard input for Moderate Sedation 43247 Egd remove foreign

body

EF031 table, power NF 44 58 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 420

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 67 92 Standard input for Moderate Sedation

EQ032 IV infusion pump NF 67 92 Standard input for Moderate Sedation

EQ235 suction machine (Gomco) NF 44 58 Refined equipment time to conform to established policies for technical equipment

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 44 58 Refined equipment time to conform to established policies for technical equipment

ES034 videoscope, gastroscopy NF 74 85 Refined equipment time to conform to established policies for technical equipment SD009 canister, suction NF 2 1 CMS clinical review

EF018 stretcher NF 78 0 Nonstandard input for Moderate Sedation 43248 Egd guide wire insertion

EF027 table, instrument,

mobile NF 34 82 Standard input for Moderate Sedation

### CMS-1600-FC 421

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EF031 table, power NF 34 48 Refined equipment time to conform to established policies for technical equipment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 57 82 Standard input for Moderate Sedation

EQ032 IV infusion pump NF 57 82 Standard input for Moderate Sedation

EQ137 instrument pack, basic ($500- $1499) NF 64 55 Refined equipment time to conform to established policies for technical equipment

EQ235 suction machine (Gomco) NF 34 48 Refined equipment time to conform to established policies for technical equipment

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 34 48 Refined equipment time to conform to established policies for technical equipment

ES034 videoscope, gastroscopy NF 64 75 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 422

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

SD009 canister, suction NF 2 1 CMS clinical review

EF018 stretcher NF 78 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 34 82 Standard input for Moderate Sedation

EF031 table, power NF 34 48 Refined equipment time to conform to established policies for technical equipment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 57 82 Standard input for Moderate Sedation

EQ032 IV infusion pump NF 57 82 Standard input for Moderate Sedation

EQ235 suction machine (Gomco) NF 34 48 Refined equipment time to conform to established policies for technical equipment 43249 Esoph egd dilation <30 mm

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 34 48 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 423

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

ES034 videoscope, gastroscopy NF 64 75 Refined equipment time to conform to established policies for technical equipment SD009 canister, suction NF 2 1 CMS clinical review

SD090 guidewire, STIFF NF 1 0 CMS clinical review

EF018 stretcher NF 78 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 34 82 Standard input for Moderate Sedation

EF031 table, power NF 34 48 Refined equipment time to conform to established policies for technical equipment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 57 82 Standard input for Moderate Sedation

EQ032 IV infusion pump NF 57 82 Standard input for Moderate Sedation 43250 Egd cautery tumor polyp

EQ113 electrosurgical generator, gastrocautery NF 34 48 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 424

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ235 suction machine (Gomco) NF 34 48 Refined equipment time to conform to established policies for technical equipment

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 34 48 Refined equipment time to conform to established policies for technical equipment

ES034 videoscope, gastroscopy NF 64 75 Refined equipment time to conform to established policies for technical equipment SD009 canister, suction NF 2 1 CMS clinical review

EF018 stretcher NF 78 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 34 82 Standard input for Moderate Sedation

EF031 table, power NF 34 48 Refined equipment time to conform to established policies for technical equipment 43251 Egd remove lesion snare

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 57 82 Standard input for Moderate Sedation

### CMS-1600-FC 425

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ032 IV infusion pump NF 57 82 Standard input for Moderate Sedation

EQ113 electrosurgical generator, gastrocautery NF 34 48 Refined equipment time to conform to established policies for technical equipment

EQ235 suction machine (Gomco) NF 34 48 Refined equipment time to conform to established policies for technical equipment

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 34 48 Refined equipment time to conform to established policies for technical equipment

ES034 videoscope, gastroscopy NF 64 75 Refined equipment time to conform to established policies for technical equipment SD009 canister, suction NF 2 1 CMS clinical review

EF018 stretcher NF 78 0 Nonstandard input for Moderate Sedation 43252 Egd optical endomicr

oscopy

EF027 table, instrument,

mobile NF 34 92 Standard input for Moderate Sedation

### CMS-1600-FC 426

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EF031 table, power NF 34 61 Refined equipment time to conform to established policies for technical equipment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 70 92 Standard input for Moderate Sedation

EQ032 IV infusion pump NF 57 92 Standard input for Moderate Sedation

EQ235 suction machine (Gomco) NF 34 61 Refined equipment time to conform to established policies for technical equipment

EQ355 optical endomicroscope

processor unit system NF 77 61 Refined equipment time to conform to established policies for technical equipment

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 34 61 Refined equipment time to conform to established policies for technical equipment

ES034 videoscope, gastroscopy NF 64 88 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 427

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

SD009 canister, suction NF 2 1 CMS clinical review

EF018 stretcher NF 88 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 44 92 Standard input for Moderate Sedation

EF031 table, power NF 44 58 Refined equipment time to conform to established policies for technical equipment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 67 92 Standard input for Moderate Sedation

EQ032 IV infusion pump NF 67 92 Standard input for Moderate Sedation

EQ113 electrosurgical generator, gastrocautery NF 44 58 Refined equipment time to conform to established policies for technical equipment 43255 Egd control bleeding any

EQ235 suction machine (Gomco) NF 44 58 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 428

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 44 58 Refined equipment time to conform to established policies for technical equipment

ES034 videoscope, gastroscopy NF 74 85 Refined equipment time to conform to established policies for technical equipment SD009 canister, suction NF 2 1 CMS clinical review

EF018 stretcher NF 103 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 82 107 Standard input for Moderate Sedation

EF031 table, power NF 59 73 Refined equipment time to conform to established policies for technical equipment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 82 107 Standard input for Moderate Sedation 43270 Egd lesion ablation

EQ032 IV infusion pump NF 82 107 Standard input for Moderate Sedation

### CMS-1600-FC 429

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ113 electrosurgical generator, gastrocautery NF 59 73 Refined equipment time to conform to established policies for technical equipment

EQ214 radiofrequency generator (NEURO) NF 59 73 CMS clinical review; see discussion in section II.D.3.b. of this final rule

EQ235 suction machine (Gomco) NF 59 73 Refined equipment time to conform to established policies for technical equipment

EQ356 kit, probe, radiofrequency, XIi-enhanced RF probe (proxy for catheter, RF

ablation, endoscopic) NF 0 73 CMS clinical review; see discussion in section II.D.3.b. of this final rule

ES031 video system, endoscopy (processor, digital capture, monitor, printer, cart) NF 59 73 Refined equipment time to conform to established policies for technical equipment

ES034 videoscope, gastroscopy NF 89 100 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 430

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

SA100 kit, probe, radiofrequency, XIi-enhanced RF probe NF 1 0 CMS clinical review

SD009 canister, suction NF 2 1 CMS clinical review

SD090 guidewire, STIFF NF 1 0 CMS clinical review

E Mobile stand, Vital Signs

Monitor NF 47 0 Nonstandard input for Moderate Sedation

EF014 light, surgical NF 24 36 Refined equipment time to conform to established policies for technical equipment

EF018 stretcher NF 51 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 24 77 Standard input for Moderate Sedation

EF031 table, power NF 24 36 Refined equipment time to conform to established policies for technical equipment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 47 77 Standard input for Moderate Sedation 43450 Dilate esophagu s 1/mult

pass

EQ032 IV infusion pump NF 47 77 Standard input for Moderate Sedation

### CMS-1600-FC 431

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ235 suction machine (Gomco) NF 24 36 Refined equipment time to conform to established policies for technical equipment

EQ357 esophageal bougies, set,

reusable NF 0 36 CMS clinical review; see discussion in section II.D.3.b. of this final rule

ES005 endoscope disinfector, rigidor fiberoptic, wcart NF 15 0 CMS clinical review

E Mobile stand, Vital Signs

Monitor NF 57 0 CMS clinical review

EF014 light, surgical NF 34 46 Refined equipment time to conform to changes in clinical labor time

EF018 stretcher NF 61 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 34 87 Standard input for Moderate Sedation 43453 Dilate esophagu s

EF031 table, power NF 34 46 Refined equipment time to conform to changes in clinical labor time

### CMS-1600-FC 432

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 57 87 Standard input for Moderate Sedation

EQ032 IV infusion pump NF 57 87 Standard input for Moderate Sedation

EQ235 suction machine (Gomco) NF 34 46 Refined equipment time to conform to changes in clinical labor time

ES005 endoscope disinfector, rigidor fiberoptic, wcart NF 15 0 CMS clinical review; an endoscope is not included

L037D RN/LPN/MTA NF Assist physician in performing procedure 25 20 Conformin g to physician time

L051A RN NF Monitor patient during Moderate Sedation 25 20 Conformin g to physician time

EF018 stretcher NF 120 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 169 162 Standard input for Moderate Sedation 49405 Image cath fluid

colxn visc

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 169 162 Standard input for Moderate Sedation

### CMS-1600-FC 433

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ032 IV infusion pump NF 169 162 Standard input for Moderate Sedation

EF018 stretcher NF 120 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 169 162 Standard input for Moderate Sedation

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 169 162 Standard input for Moderate Sedation 49406 Image cath fluid peri/retro

EQ032 IV infusion pump NF 169 162 Standard input for Moderate Sedation

EF018 stretcher NF 120 0 Nonstandard input for Moderate Sedation

EF027 table, instrument,

mobile NF 174 167 Standard input for Moderate Sedation

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 174 167 Standard input for Moderate Sedation 49407 Image cath fluid trns/vgnl

EQ032 IV infusion pump NF 174 167 Standard input for Moderate Sedation

63650 Implant neuroele ctrodes EF018 stretcher NF 10 15 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 434

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EF024 table, fluoroscopy NF 60 84 Refined equipment time to conform to established policies for technical equipment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 60 84 Refined equipment time to conform to established policies for technical equipment

ER031 fluoroscopic system, mobile C-Arm NF 60 69 Refined equipment time to conform to established policies for technical equipment

L037D RN/LPN/MTA NF Clean Surgical Instrument Package 15 0 Standardiz ed time input

SA043 pack, cleaning, surgical instruments NF 1 0 CMS clinical review

EF023 table, exam NF 28 24 Refined equipment time to conform to changes in clinical labor time 64616 Chemode nerv musc neck dyston

L037D RN/LPN/MTA NF Other Clinical Activity: Complete botox log 3 0 CMS clinical review

### CMS-1600-FC 435

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

L037D RN/LPN/MTA NF Assist physician in performing procedure 7 5 Conformin g to physician time

EF023 table, exam NF 30 33 Refined equipment time to conform to changes in clinical labor time 64617 Chemode ner muscle larynx

emg EQ024 EMG-NCV-EP system, 8 channel NF 30 33 Refined equipment time to conform to changes in clinical labor time

EF023 table, exam NF 44 38 Refined equipment time to conform to changes in clinical labor time 64642 Chemode nerv 1 extremity 1-4

L037D RN/LPN/MTA NF Other Clinical Activity: Complete botox log 3 0 CMS clinical review

EF023 table, exam NF 49 43 Refined equipment time to conform to established policies for technical equipment 64644 Chemode nerv 1 extrem 5/> mus

L037D RN/LPN/MTA NF Other Clinical Activity: Complete botox log 3 0 CMS clinical review

### CMS-1600-FC 436

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EF023 table, exam NF 44 38 Refined equipment time to conform to established policies for technical equipment 64646 Chemode nerv trunk musc 1-5

L037D RN/LPN/MTA NF Other Clinical Activity: Complete botox log 3 0 CMS clinical review

EF023 table, exam NF 49 43 Refined equipment time to conform to established policies for technical equipment 64647 Chemode nerv trunk musc 6/>

L037D RN/LPN/MTA NF Other Clinical Activity: Complete botox log 3 0 CMS clinical review

EF015 mayo stand NF 31 20 Refined equipment time to conform to established policies for technical equipment 67914 Repair eyelid defect

EL006 lane, screening (oph) NF 121 110 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 437

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EQ114 electrosurgical generator, up to 120 watts NF 31 20 Refined equipment time to conform to established policies for technical equipment

EQ138 instrument pack, medium ($1500 and up) NF 43 20 Refined equipment time to conform to established policies for technical equipment

EQ176 loupes, standard, up to 3.5x NF 31 20 Refined equipment time to conform to established policies for technical equipment

L038A COMT/COT/RN /CST NF Clean Surgical Instrument Package 15 10 Standardiz ed time input

SC027 needle, 18-19g, filter NF SB034 SC027 Supply/Eq uipment code correction

SC057 syringe 5-6ml NF SK057 SC057 Supply/Eq uipment code correction

67915 Repair eyelid defect EF015 mayo stand NF 21 10 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 438

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EL006 lane, screening (oph) NF 71 64 Refined equipment time to conform to established policies for technical equipment

EQ114 electrosurgical generator, up to 120 watts NF 21 10 Refined equipment time to conform to established policies for technical equipment

EQ176 loupes, standard, up to 3.5x NF 21 10 Refined equipment time to conform to established policies for technical equipment

SB027 gown, staff, impervious NF SB034 SB027 Supply/Eq uipment code correction

SC057 syringe 5-6ml NF SK057 SC057 Supply/Eq uipment code correction

SB027 gown, staff, impervious NF SB034 SB027 Supply/Eq uipment code correction 67916 Repair eyelid defect SC057 syringe 5-6ml NF SK057 SC057 Supply/Eq uipment code correction

SB027 gown, staff, impervious NF SB034 SB027 Supply/Eq uipment code correction 67917 Repair eyelid defect SC057 syringe 5-6ml NF SK057 SC057 Supply/Eq uipment code correction

### CMS-1600-FC 439

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

SB027 gown, staff, impervious NF SB034 SB027 Supply/Eq uipment code correction 67921 Repair eyelid defect SC057 syringe 5-6ml NF SK057 SC057 Supply/Eq uipment code correction

SB027 gown, staff, impervious NF SB034 SB027 Supply/Eq uipment code correction 67922 Repair eyelid defect SC057 syringe 5-6ml NF SK057 SC057 Supply/Eq uipment code correction

SB027 gown, staff, impervious NF SB034 SB027 Supply/Eq uipment code correction 67923 Repair eyelid defect SC057 syringe 5-6ml NF SK057 SC057 Supply/Eq uipment code correction

SB027 gown, staff, impervious NF SB034 SB027 Supply/Eq uipment code correction 67924 Repair eyelid defect SC057 syringe 5-6ml NF SK057 SC057 Supply/Eq uipment code correction

ED024 film processor, dry, laser NF 15 4 Refined equipment time to conform to established policies for technical equipment 70450 Ct head/brai

n w/o

dye

EL007 room, CT NF 26 17 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 440

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

ER029 film alternator (motorized film viewbox) NF 15 4 Refined equipment time to conform to established policies for technical equipment

ED024 film processor, dry, laser NF 15 4 Refined equipment time to conform to established policies for technical equipment

EL007 room, CT NF 34 24 Refined equipment time to conform to established policies for technical equipment 70460 Ct head/brai n w/dye

ER029 film alternator (motorized film viewbox) NF 15 4 Refined equipment time to conform to established policies for technical equipment

ED024 film processor, dry, laser NF 15 6 Refined equipment time to conform to established policies for technical equipment 70470 Ct head/brai n w/o &

w/dye

EL007 room, CT NF 42 30 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 441

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

ER029 film alternator (motorized film viewbox) NF 15 6 Refined equipment time to conform to established policies for technical equipment

70551 Mri brain stem w/o dye EL008 room, MRI NF 33 31 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 442

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

L047A MRI Technologist NF Other Clinical Activity: Retrieve

prior appropriate

imaging exams and

hang for MD review, verify orders, review the

chart to incorporate

relevant clinical information and confirm contrast protocol

with interpreting MD 8 3 CMS clinical review

L047A MRI Technologist NF Assist physician in performing procedure 30 20 CMS clinical review

### CMS-1600-FC 443

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

L047A MRI Technologist NF Other Clinical Activity:

Escort patient from exam room due to

magnetic sensitivity 2 0 CMS clinical review

70552 Mri brain stem w/dye EL008 room, MRI NF 47 45 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 444

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

L047A MRI Technologist NF Other Clinical Activity: Retrieve

prior appropriate

imaging exams and

hang for MD review, verify orders, review the

chart to incorporate

relevant clinical information and confirm contrast protocol

with interpreting MD 8 5 CMS clinical review

L047A MRI Technologist NF Obtain vital signs 0 3 CMS clinical review

L047A MRI Technologist NF Provide preservice education/o btain consent 9 7 CMS clinical review

### CMS-1600-FC 445

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

L047A MRI Technologist NF Other Clinical Activity:

Escort patient from exam room due to

magnetic sensitivity 2 0 CMS clinical review

SG053 gauze, sterile 2in x 2in NF 1 0 CMS clinical review

SG089 tape, phix strips (for nasal catheter) NF 6 0 CMS clinical review

SJ043 povidone swabsticks (3

pack uou) NF 1 0 CMS clinical review

SJ053 swab-pad, alcohol NF 1 0 CMS clinical review

70553 Mri brain stem w/o & w/dye EL008 room, MRI NF 57 53 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 446

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

L047A MRI Technologist NF Other Clinical Activity: Retrieve

prior appropriate

imaging exams and

hang for MD review, verify orders, review the

chart to incorporate

relevant clinical information and confirm contrast protocol

with interpreting MD 8 5 CMS clinical review

L047A MRI Technologist NF Obtain vital signs 0 3 CMS clinical review

L047A MRI Technologist NF Provide preservice education/o btain consent 9 7 CMS clinical review

### CMS-1600-FC 447

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

L047A MRI Technologist NF Assist physician in performing procedure 40 38 CMS clinical review

L047A MRI Technologist NF Other Clinical Activity:

Escort patient from exam room due to

magnetic sensitivity 2 0 CMS clinical review

SG053 gauze, sterile 2in x 2in NF 1 0 CMS clinical review

SG089 tape, phix strips (for nasal catheter) NF 6 0 CMS clinical review

SJ043 povidone swabsticks (3

pack uou) NF 1 0 CMS clinical review

SJ053 swab-pad, alcohol NF 1 0 CMS clinical review

72141 Mri neck spine w/o dye L047A MRI Technologist NF Other Clinical Activity:

Escort patient from exam room due to

magnetic sensitivity 2 0 CMS clinical review

### CMS-1600-FC 448

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

72142 Mri neck spine w/dye L047A MRI Technologist NF Other Clinical Activity:

Escort patient from exam room due to

magnetic sensitivity 2 0 CMS clinical review

72146 Mri chest spine w/o dye L047A MRI Technologist NF Other Clinical Activity:

Escort patient from exam room due to

magnetic sensitivity 2 0 CMS clinical review

72147 Mri chest spine w/dye L047A MRI Technologist NF Other Clinical Activity:

Escort patient from exam room due to

magnetic sensitivity 2 0 CMS clinical review

### CMS-1600-FC 449

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

72148 Mri lumbar spine w/o dye L047A MRI Technologist NF Other Clinical Activity:

Escort patient from exam room due to

magnetic sensitivity 2 0 CMS clinical review

72149 Mri lumbar spine w/dye L047A MRI Technologist NF Other Clinical Activity:

Escort patient from exam room due to

magnetic sensitivity 2 0 CMS clinical review

72156 Mri neck spine w/o & w/dye L047A MRI Technologist NF Other Clinical Activity:

Escort patient from exam room due to

magnetic sensitivity 2 0 CMS clinical review

### CMS-1600-FC 450

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

72157 Mri chest spine w/o & w/dye L047A MRI Technologist NF Other Clinical Activity:

Escort patient from exam room due to

magnetic sensitivity 2 0 CMS clinical review

72158 Mri lumbar spine w/o & w/dye L047A MRI Technologist NF Other Clinical Activity:

Escort patient from exam room due to

magnetic sensitivity 2 0 CMS clinical review

74174 Ct angio abd&pel v w/o&w/d ye L046A CT Technologist NF Other Clinical Activity: Process films, hang films and

review study with interpreting MD prior to patient discharge 25 20 CMS clinical review

75726 Artery xrays abdomen L041A Angio Technician NF Assist physician in performing procedure 73 45 CMS clinical review

### CMS-1600-FC 451

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

E Virtual Simulation

Package NF 27 0 CMS clinical review

77280 Set radiation therapy

field ER057 radiation virtual simulation

system NF 0 27 CMS clinical review; inadequate informatio n to price new items; existing item used as a proxy

E Virtual Simulation

Package NF 43 0 CMS clinical review

77285 Set radiation therapy

field ER057 radiation virtual simulation

system NF 0 43 CMS clinical review; inadequate informatio n to price new items; existing item used as a proxy

E Virtual Simulation

Package NF 50 0 CMS clinical review

77290 Set radiation therapy

field ER057 radiation virtual simulation

system NF 0 50 CMS clinical review; inadequate informatio n to price new items; existing item used as a proxy

E Virtual Simulation

Package NF 40 0 CMS clinical review 77293 Respirato r motion

mgmt simul E 4D Simulation Package NF 40 0 CMS clinical review

### CMS-1600-FC 452

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

ER057 radiation virtual simulation

system NF 0 40 CMS clinical review; inadequate informatio n to price new items; existing item used as a proxy

EQ211 pulse oximeter w-printer NF 104 86 Refined equipment time to conform to established policies for technical equipment

ER056 radiation treatment vault NF 0 86 See discussion in section II.D.3.b. of this final rule 77373 Sbrt delivery

ER083 SRS system, SBRT, six systems, average NF 104 86 Refined equipment time to conform to established policies for technical equipment

EF015 mayo stand NF 123 105 Refined equipment time to conform to established policies for technical equipment 77600 Hyperthe rmia treatment

ER035 hyperthermia system, ultrasound,

external NF 123 105 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 453

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

L037D RN/LPN/MTA NF Clean Scope 10 0 CMS clinical review; catheters included are disposable supplies and time is already included for cleaning equipment

E Emergency service container-safety kit NF 46 0 Indirect practice expense

EF021 table, brachytherapy

treatment NF 46 42 Refined equipment time to conform to established policies for technical equipment

EQ292 Applicator Base Plate NF 46 42 Refined equipment time to conform to established policies for technical equipment 77785 Hdr brachytx 1 channel

ER003 HDR Afterload System, Nucletron -

Oldelft NF 46 42 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 454

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

ER028 electrometer, PC-based, dual channel NF 46 42 Refined equipment time to conform to established policies for technical equipment

ER054 radiation survey meter NF 46 42 Refined equipment time to conform to established policies for technical equipment

ER060 source, 10 Ci Ir 192 NF 46 42 Refined equipment time to conform to established policies for technical equipment

ER062 stirrups (for brachytherapy table) NF 46 42 Refined equipment time to conform to established policies for technical equipment

ER073 Area Radiation Monitor NF 46 42 Refined equipment time to conform to established policies for technical equipment

77786 Hdr brachytx

2-12 channel E Emergency service container-safety kit NF 100 0 Indirect practice expense

### CMS-1600-FC 455

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EF021 table, brachytherapy

treatment NF 100 86 Refined equipment time to conform to established policies for technical equipment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 100 86 Refined equipment time to conform to established policies for technical equipment

EQ292 Applicator Base Plate NF 100 86 Refined equipment time to conform to established policies for technical equipment

ER003 HDR Afterload System, Nucletron -

Oldelft NF 100 86 Refined equipment time to conform to established policies for technical equipment

ER028 electrometer, PC-based, dual channel NF 100 86 Refined equipment time to conform to established policies for technical equipment

ER054 radiation survey meter NF 100 86 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 456

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

ER060 source, 10 Ci Ir 192 NF 100 86 Refined equipment time to conform to established policies for technical equipment

ER073 Area Radiation Monitor NF 100 86 Refined equipment time to conform to established policies for technical equipment

E Emergency service container-safety kit NF 162 0 Indirect practice expense

EF021 table, brachytherapy

treatment NF 162 137 Refined equipment time to conform to established policies for technical equipment

EQ011 ECG, 3-channel (with SpO2, NIBP, temp, resp) NF 162 137 Refined equipment time to conform to established policies for technical equipment 77787 Hdr brachytx over 12

chan

EQ292 Applicator Base Plate NF 162 137 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 457

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

ER003 HDR Afterload System, Nucletron -

Oldelft NF 162 137 Refined equipment time to conform to established policies for technical equipment

ER028 electrometer, PC-based, dual channel NF 162 137 Refined equipment time to conform to established policies for technical equipment

ER054 radiation survey meter NF 162 137 Refined equipment time to conform to established policies for technical equipment

ER060 source, 10 Ci Ir 192 NF 162 137 Refined equipment time to conform to established policies for technical equipment

ER062 stirrups (for brachytherapy table) NF 162 137 Refined equipment time to conform to established policies for technical equipment

ER073 Area Radiation Monitor NF 162 137 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 458

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

E Laboratory Information System with maintenance

contract NF 2 0 Included in equipment cost per minute calculation

E Copath System Software NF 2 0 Indirect practice expense

L035A Lab Tech/Histotechn ologist NF Order, restock, and distribute specimen containers with requisition forms. 0.5 0 CMS clinical review

L045A Cytotechnologist NF Perform screening function (where applicable) 8 0 CMS clinical review 88112 Cytopath cell enhance

tech

L045A Cytotechnologist NF A. Confirm patient ID, organize work, verify and review history 2 0 CMS clinical review

### CMS-1600-FC 459

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

L045A Cytotechnologist NF B: Enter screening diagnosis in laboratory information system, complete workload recording logs, manage any relevant utilization review/qual ity assurance activities and regulatory compliance documentat ion and assemble and deliver slides with paperwork to pathologist 2 0 CMS clinical review

S Courier transportation costs NF 2.02 0 Indirect practice expense

S Specimen, solvent, and

formalin disposal cost NF 0.18 0 Indirect practice expense

### CMS-1600-FC 460

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

ED021 computer,desktop, wmonitor NF 68 51 Refined equipment time to conform to established policies for technical equipment

ED034 video SVHS VCR (medical grade) NF 68 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

ED036 video printer, color (Sony medical grade) NF 10 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs 93880 Extracra nial bilat

study

EL016 room, ultrasound,

vascular NF 68 51 Refined equipment time to conform to established policies for technical equipment

93882 Extracra nial uni/ltd study ED021 computer,desktop, wmonitor NF 44 29 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 461

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

ED034 video SVHS VCR (medical grade) NF 44 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

ED036 video printer, color (Sony medical grade) NF 10 0 CMS clinical review; functionali ty of items redundant with other direct PE inputs

EL016 room, ultrasound,

vascular NF 44 29 Refined equipment time to conform to established policies for technical equipment

94667 Chest wall manipula tion EF023 table, exam NF 1 35 Refined equipment time to conform to changes in clinical labor time

94668 Chest wall manipula tion EF023 table, exam NF 1 33 Refined equipment time to conform to changes in clinical labor time

94669 Mechani cal chest

wall oscill EF023 table, exam NF 1 45 Refined equipment time to conform to changes in clinical labor time

### CMS-1600-FC 462

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

95816 Eeg awake

and drowsy EQ330 EEG, digital, testing system

(computer hardware, software &

camera) NF 116 107 Refined equipment time to conform to established policies for technical equipment

95819 Eeg awake

and asleep EQ330 EEG, digital, testing system

(computer hardware, software &

camera) NF 148 139 Refined equipment time to conform to established policies for technical equipment

95822 Eeg coma or

sleep only EQ330 EEG, digital, testing system

(computer hardware, software &

camera) NF 123 114 Refined equipment time to conform to established policies for technical equipment

ED005 camera, digital system, 12 megapixel (medical grade) NF 50 60 Refined equipment time to conform to established policies for technical equipment

ED021 computer,desktop, wmonitor NF 50 0 Indirect practice expense 99170 Anogenit al exam child w

imag

EF015 mayo stand NF 50 60 Refined equipment time to conform to established policies for technical equipment

### CMS-1600-FC 463

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

EF031 table, power NF 50 60 Refined equipment time to conform to established policies for technical equipment

EQ170 light, fiberopticheadlight wsource NF 50 60 Refined equipment time to conform to established policies for technical equipment

ES004 colposcope NF 50 67 Refined equipment time to conform to established policies for technical equipment

L051A RN NF Coordinate pre-surgery services 0 3 CMS clinical review

L051A RN NF Other Clinical Activity (Preservice) 5 0 CMS clinical review

L051A RN NF Other Clinical Activity (Post Service) 15 3 CMS clinical review

SA048 pack, minimum multi-specialty visit F 1 0 Service period supplies are not included in the facility setting

### CMS-1600-FC 464

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

SB006 drape, nonsterile, sheet 40in x 60in F 1 0 Service period supplies are not included in the facility setting

SB022 gloves, nonsterile F 1 0 Service period supplies are not included in the facility setting

SD118 specula, vaginal F 1 0 Service period supplies are not included in the facility setting

SG008 applicator, cotton-tipped, non-sterile 6in F 2 0 Service period supplies are not included in the facility setting

SJ033 lubricating jelly (Surgilube) F 1 0 Service period supplies are not included in the facility setting

SL146 tubed culture media F 2 0 Service period supplies are not included in the facility setting

### CMS-1600-FC 465

HCPCS

Code HCPCS CodeDescription Input Code Input Code Description NonFac/ Fac Labor Activity (if applicable) RUC Recommen

dation or Current Value (min

or qty) CMS Refine ment (min or

qty) Comment

SL157 cup, sterile, 8 oz F 1 0 Service period supplies are not included in the facility setting

E Specimen, solvent, and

formalin disposal cost NF 0.35 0 Indirect practice expense

E Laboratory Information System with maintenance

contract NF 2 0 Included in equipment cost per minute calculation

E Copath System Software NF 2 0 Indirect practice expense

EP043 water bath, general purpose (lab) NF 8 5 CMS clinical review G0461 Immuno histoche mistry, initial antibody

ER041 microtome NF 8 5 CMS clinical review

EP112 Benchmark ULTRA automated slide

preparation

system NF 33 15 CMS clinical review G0462 Immuno histoche mistry, subseque nt antibody SL489 UtraView Universal Alkaline Phosphatase Red

Detection Kit NF 0.2 2 CMS clinical review

c. Establishing CY 2014 Interim Final Malpractice RVUs According to our malpractice methodology discussed in section II.C, we are assigning malpractice RVUs for CY 2014 new, revised and pot entially misvalued codes by utilizing a crosswalk to a source code with a similar malpractice risk. We have reviewed the AMA RUC recommended

### CMS-1600-FC 466

malpractice source code crosswalks for CY 2014 new, revised and potentially misvalued codes, and we are accepting all of them on an interim final basis for CY 2014. For CY 2014, we created two HCPCS G-codes. HCPCS code G0461 (Immunohistochemistry or immunocytochemistry, per specimen; first stain with separately identifiable antibody(ies)) was created to replace CPT code 88342 (immunohistochemistry or i mmunocytochemistry, each separately identifiable antibody per block, cytologic preparation, or hemato logic smear; first separately identifiable antibody per slide), which is Invalid effective January 1, 2014. We believe CPT code 88342 has a similar malpractice risk-of-service as HCPCS code G0461. Therefore, we are assigning an interim final malpractice

crosswalk of CPT code 88342 to HCPCS code G046 1 on an interim final basis for CY 2014. HCPCS code G0462 (Immunohistochemistry or immunocytochemi stry, per specimen; each additional stain with separately identifiable antibody(ies) (List separately in addition to code for primary procedure) was created to replace CPT code 88343 (immunohistochemistry or immunocytochemistry, each separately identifiable antibody per block, cytologic preparation, or hematologic smear; each additional separately identifiable antibody per slide (list separately in additi on to code for primary procedure), which is invalid effective Janauary 1, 2014. We believe CPT c ode 88343 has a similar malp ractice risk-of-service as HCPCS code G0462. Therefore, we are assigning an interim final malpractice crosswalk of CPT code

88343 to HCPCS code G0462 on an interim final basis for CY 2014. Table 30 lists the adjusted CY 2013 and new/re vised CY 2014 HCPCS codes and their respective

source codes used to set the interim final CY 2014 malpractice RVUs. The malpractice RVUs for these services are reflected in Addendum B of this CY 2014 PFS final rule with comment period. Consistent with past practice when the MEI has been rebased or revised we proposed to make adjustments to ensure that estimates of the aggregate CY 2014 PFS payments for work, PE and malpractice are in proportion to the weights for these categories in the revised MEI. As discussed in the II.B. and II.D., the MEI is being revised, the PE and malpractice RVUs, and the CF are being adjusted accordingly. For more information on this, see tho se sections. We received no comments specifically on the adjustment to malpractice RVUs.

### CMS-1600-FC 467

TABLE 30: Crosswalk for Establishing CY 2014 New/Revised/Potentially Misvalued Codes Malpractice RVUs

CY 2014 New, Revised, or Potentially Misvalued HCPCS Code Malpractice Risk Factor Crosswalk HCPCS Code 10030 Guide cathet fluid drainage 37200 transcatheter biopsy 13152 Cmplx rpr e/n/e/l 2.6-7.5 cm 13152 cmplx rpr e/n/e/l 2.6-7.5 cm 17000 Destruct premalg lesion 17000 destruct premalg lesion 17003 Destruct premalg les 2-14 17003 destruct premalg les 2-14 17004 Destroy premal lesions 15/> 17004 destroy premal lesions 15/> 17311 Mohs 1 stage h/n/hf/g 17311 mohs 1 stage h/n/hf/g 17312 Mohs addl stage 17312 mohs addl stage 17313 Mohs 1 stage t/a/l 17313 mohs 1 stage t/a/l 17314 Mohs addl stage t/a/l 17314 mohs addl stage t/a/l 17315 Mohs surg addl block 17315 mohs surg addl block 19081 Bx breast 1st Lesion strtctc 32553 ins mark thor for rt perq 19082 Bx breast add Lesion strtctc 64480 inj foramen epidural add-on 19083 Bx breast 1st Lesion US imag 32551 insertion of chest tube 19084 Bx breast add Lesion US imag 64480 inj foramen epidural add-on 19085 Bx breast 1st lesion mr imag 36565 insert tunneled cv cath 19086 Bx breast add lesion mr imag 76812 ob us detailed addl fetus 19281 Perq device breast 1st imag 50387 change ext/int ureter stent 19282 Perq device breast ea imag 76812 ob us detailed addl fetus 19283 Perq dev breast 1st strtctc 50387 change ext/int ureter stent 19284 Perq dev breast add strtctc 76812 ob us detailed addl fetus 19285 Perq dev breast 1st us imag 36569 insert picc cath 19286 Perq dev breast add us imag 76812 ob us detailed addl fetus 19287 Perq dev breast 1st mr guide 32551 insertion of chest tube 19288 Perq dev breast add mr guide 76812 ob us detailed addl fetus 23333 Remove shoulder fb deep 23472 reconstruct shoulder joint 23334 Shoulder prosthesis removal 23472 reconstruct shoulder joint 23335 Shoulder prosthesis removal 23472 reconstruct shoulder joint 24160 Remove elbow joint impl ant 24363 replace elbow joint 24164 Remove radius head implant 23430 repair biceps tendon 27130 Total hip arthroplasty 27130 total hip arthroplasty 27236 Treat thigh fracture 27236 treat thigh fracture 27446 Revision of knee joint 27446 revision of knee joint 27447 Total knee arthroplasty 27447 total knee arthroplasty 31237 Nasal/sinus endoscopy surg 31237 nasal/sinus endoscopy surg

### CMS-1600-FC 468

CY 2014 New, Revised, or Potentially Misvalued HCPCS Code Malpractice Risk Factor Crosswalk HCPCS Code 31238 Nasal/sinus endoscopy surg 31238 nasal/sinus endoscopy surg 31239 Nasal/sinus endoscopy surg 31239 nasal/sinus endoscopy surg 31240 Nasal/sinus endoscopy surg 31240 nasal/sinus endoscopy surg 33282 Implant pat-active ht record 33282 implant pat-active ht record 33284 Remove pat-active ht record 33284 remove pat-active ht record 33366 Trcath replace aortic valve 3 3979 insert intracorporeal device 35301 Rechanneling of artery 35301 rechanneling of artery 35475 Repair arterial blockage 35475 repair arterial blockage 35476 Repair venous blockage 3 5476 repair venous blockage 36245 Ins cath abd/l-ext art 1st 36245 ins cath abd/l-ext art 1st 37217 Stent placemt retro carotid 37660 revision of major vein 37236 Open/perq place stent 1st 3 6247 ins cath abd/l-ext art 3rd 37237 Open/perq place stent ea add 3 7223 iliac revasc w/stent add-on 37238 Open/perq place stent same 36247 ins cath abd/l-ext art 3rd 37239 Open/perq place stent ea add 3 7223 iliac revasc w/stent add-on 37241 Vasc embolize/occlude venous 37204 transcatheter occlusion 37242 Vasc embolize/occlude artery 37204 transcatheter occlusion 37243 Vasc embolize/occlude organ 37204 transcatheter occlusion 37244 Vasc embolize/occlude bleed 37204 transcatheter occlusion 38240 Transplt allo hct/donor 38240 transplt allo hct/donor 43191 Esophagoscopy rigid trnso dx 31575 diagnostic laryngoscopy 43192 Esophagoscp rig trnso inject 31575 diagnostic laryngoscopy 43193 Esophagoscp rig trnso biopsy 31575 diagnostic laryngoscopy 43194 Esophagoscp rig trnso rem fb 31575 diagnostic laryngoscopy 43195 Esophagoscopy rigid balloon 31575 diagnostic laryngoscopy 43196 Esophagoscp guide wire dilat 31638 bronchoscopy revise stent 43197 Esophagoscopy flex dx brush 31575 diagnostic laryngoscopy 43198 Esophagosc flex trnsn biopsy 31575 diagnostic laryngoscopy 43200 Esophagoscopy flexible brush 43200 esophagoscopy flexible brush 43201 Esoph scope w/submucous inj 43201 esoph scope w/submucous inj 43202 Esophagoscopy flex biopsy 43202 esophagoscopy flex biopsy 43204 Esoph scope w/sclerosis inj 43204 esoph scope w/sclerosis inj 43205 Esophagus endoscopy/ligation 43205 esophagus endoscopy/ligation 43206 Esoph optical endomicroscopy 43200 esophagoscopy flexible brush 43211 Esophagoscop mucosal resect 43201 esoph scope w/submucous inj 43212 Esophagoscop stent placem ent 43219 esophagus endoscopy

### CMS-1600-FC 469

CY 2014 New, Revised, or Potentially Misvalued HCPCS Code Malpractice Risk Factor Crosswalk HCPCS Code 43213 Esophagoscopy retro balloon 43456 dilate esophagus 43214 Esophagosc dilate balloon 30 43458 dilate esophagus 43215 Esophagoscopy flex remove fb 43215 esophagoscopy flex remove fb 43216 Esophagoscopy lesion removal 43216 esophagoscopy lesion removal 43217 Esophagoscopy snare les remv 43217 esophagoscopy snare les remv 43220 Esophagoscopy balloon <30mm 43220 esophagoscopy balloon <30mm 43226 Esoph endoscopy dilation 43226 esoph endoscopy dilation 43227 Esophagoscopy control bleed 43227 esophagoscopy control bleed 43229 Esophagoscopy lesion ablate 43228 esoph endoscopy ablation 43231 Esophagoscop ultrasound exam 43231 esophagoscop ultrasound exam 43232 Esophagoscopy w/us needle bx 43232 esophagoscopy w/us needle bx 43233 Egd balloon dil esoph30 mm/> 43271 endo cholangiopancreatograph 43235 Egd diagnostic brush wash 43235 egd diagnostic brush wash 43236 Uppr gi scope w/submuc inj 43236 uppr gi scope w/submuc inj 43237 Endoscopic us exam esoph 43237 endoscopic us exam esoph 43238 Egd us fine needle bx/aspir 43238 egd us fine needle bx/aspir 43239 Egd biopsy single/multiple 43239 egd biopsy single/multiple 43240 Egd w/transmural drain cyst 43240 egd w/transmural drain cyst 43241 Egd tube/cath insertion 43241 egd tube/cath insertion 43242 Egd us fine needle bx/aspir 43242 egd us fine needle bx/aspir 43243 Egd injection varices 43243 egd injection varices 43244 Egd varices ligation 43244 egd varices ligation 43245 Egd dilate stricture 43245 egd dilate stricture 43246 Egd place gastrostomy tube 43246 egd place gastrostomy tube 43247 Egd remove foreign body 43247 egd remove foreign body 43248 Egd guide wire insertion 43248 egd guide wire insertion 43249 Esoph egd dilation <30 mm 43249 esoph egd dilation <30 mm 43250 Egd cautery tumor polyp 43250 egd cautery tumor polyp 43251 Egd remove lesion snare 43251 egd remove lesion snare 43252 Egd optical endomicroscopy 43200 esophagoscopy flexible brush 43253 Egd us transmural injxn/mark 43242 egd us fine needle bx/aspir 43254 Egd endo mucosal resection 43251 egd remove lesion snare 43255 Egd control bleeding any 43255 egd control bleeding any 43257 Egd w/thrml txmnt gerd 43257 egd w/thrml txmnt gerd 43259 Egd us exam duodenum/jejunum 43259 egd us exam duodenum/jejunum 43260 Ercp w/specimen collection 43260 ercp w/specimen collection

### CMS-1600-FC 470

CY 2014 New, Revised, or Potentially Misvalued HCPCS Code Malpractice Risk Factor Crosswalk HCPCS Code 43261 Endo cholangiopancreatograph 43261 endo cholangiopancreatograph 43262 Endo cholangiopancreatograph 43262 endo cholangiopancreatograph 43263 Ercp sphincter pressure meas 43263 ercp sphincter pressure meas 43264 Ercp remove duct calculi 43264 ercp remove duct calculi 43265 Ercp lithotripsy calculi 43265 ercp lithotripsy calculi 43266 Egd endoscopic stent place 4 3256 uppr gi endoscopy w/stent 43270 Egd lesion ablation 43258 operative upper gi endoscopy 43273 Endoscopic pancreatoscopy 43273 endoscopic pancreatoscopy 43274 Ercp duct stent placement 4 3268 endo cholangiopancreatograph 43275 Ercp remove forgn body duct 43269 endo cholangiopancreatograph 43276 Ercp stent exchange w/dilate 43269 endo cholangiopancreatograph 43277 Ercp ea duct/ampulla dilate 43271 endo cholangiopancreatograph 43278 Ercp lesion ablate w/dilate 43272 endo cholangiopancreatograph 43450 Dilate esophagus 1/mult pass 43450 dilate esophagus 1/mult pass 43453 Dilate esophagus 43453 dilate esophagus 49405 Image cath fluid colxn visc 37200 transcatheter biopsy 49406 Image cath fluid peri/retro 37200 transcatheter biopsy 49407 Image cath fluid trns/vgnl 37200 transcatheter biopsy 50360 Transplantation of kidney 50360 transplantation of kidney 52332 Cystoscopy and treatment 52332 cystoscopy and treatment 52353 Cystouretero w/lithotripsy 52353 cystouretero w/lithotripsy 52356 Cysto/uretero w/lithotripsy 52353 cystouretero w/lithotripsy 62310 Inject spine cerv/thoracic 62310 inject sp ine cerv/thoracic 62311 Inject spine lumbar/sacral 62311 inject spine lumbar/sacral 62318 Inject spine w/cath crv/thrc 62318 inject spine w/cath crv/thrc 62319 Inject spine w/cath lmb/scrl 62319 inject spine w/cath lmb/scrl 63047 Remove spine lamina 1 lmbr 63047 remove spine lamina 1 lmbr 63048 Remove spinal lamina add-on 63048 remove spinal lamina add-on 63650 Implant neuroelectrodes 63650 implant neuroelectrodes 64613 Destroy nerve neck muscle 64613 destroy nerve neck muscle 64614 Destroy nerve extrem musc 64614 destroy nerve extrem musc 64616 Chemodenerv musc neck dyston 64613 destroy nerve neck muscle 64617 Chemodener muscle larynx emg 31513 injection into vocal cord 64642 Chemodenerv 1 extremity 1-4 64614 destroy nerve extrem musc 64643 Chemodenerv 1 extrem 1-4 ea 64614 destroy nerve extrem musc 64644 Chemodenerv 1 extrem 5/> mus 64614 destroy nerve extrem musc

### CMS-1600-FC 471

CY 2014 New, Revised, or Potentially Misvalued HCPCS Code Malpractice Risk Factor Crosswalk HCPCS Code 64645 Chemodenerv 1 extrem 5/> ea 64614 destroy nerve extrem musc 64646 Chemodenerv trunk musc 1-5 64614 destroy nerve extrem musc 64647 Chemodenerv trunk musc 6/> 64614 destroy nerve extrem musc 66180 Implant eye shunt 66180 implant eye shunt 66183 Insert ant drainage device 65850 incision of eye 66185 Revise eye shunt 66185 revise eye shunt 67255 Reinforce/graft eye wall 67255 reinforce/graft eye wall 67914 Repair eyelid defect 67914 repair eyelid defect 67915 Repair eyelid defect 67915 repair eyelid defect 67916 Repair eyelid defect 67916 repair eyelid defect 67917 Repair eyelid defect 67917 repair eyelid defect 67921 Repair eyelid defect 67921 repair eyelid defect 67922 Repair eyelid defect 67922 repair eyelid defect 67923 Repair eyelid defect 67923 repair eyelid defect 67924 Repair eyelid defect 67924 repair eyelid defect 69210 Remove impacted ear wax uni 69210 remove impacted ear wax uni 70450 Ct head/brain w/o dye 70450 ct head/brain w/o dye 70460 Ct head/brain w/dye 70460 ct head/brain w/dye 70551 Mri brain stem w/o dye 70551 mri brain stem w/o dye 70552 Mri brain stem w/dye 70552 mri brain stem w/dye 70553 Mri brain stem w/o & w/dye 70553 mri brain stem w/o & w/dye 72141 Mri neck spine w/o dye 72141 mri neck spine w/o dye 72142 Mri neck spine w/dye 72142 mri neck spine w/dye 72146 Mri chest spine w/o dye 72146 mri chest spine w/o dye 72147 Mri chest spine w/dye 72147 mri chest spine w/dye 72148 Mri lumbar spine w/o dye 72148 mri lumbar spine w/o dye 72149 Mri lumbar spine w/dye 72149 mri lumbar spine w/dye 72156 Mri neck spine w/o & w/dye 72156 mri neck spine w/o & w/dye 72157 Mri chest spine w/o & w/dye 72157 mri chest spine w/o & w/dye 72158 Mri lumbar spine w/o & w/dye 72158 mri lumbar spine w/o & w/dye 72191 Ct angiograph pelv w/o&w/dye 72191 ct angiograph pelv w/o&w/dye 74174 Ct angio abd&pelv w/o&w/dye 74174 ct angio abd&pelv w/o&w/dye 74175 Ct angio abdom w/o & w/dye 74175 ct angio abdom w/o & w/dye 77001 Fluoroguide for vein device 77001 fluoroguide for vein device 77002 Needle localization by xray 77002 needle localization by xray 77003 Fluoroguide for spine inject 77003 fluoroguide for spine inject

### CMS-1600-FC 472

CY 2014 New, Revised, or Potentially Misvalued HCPCS Code Malpractice Risk Factor Crosswalk HCPCS Code 77280 Set radiation therapy field 77280 set radiation therapy field 77285 Set radiation therapy field 77285 set radiation therapy field 77290 Set radiation therapy field 77290 set radiation therapy field 77293 Respirator motion mgmt simul 77470 special radiation treatment 77295 3-d radiotherapy plan 77295 3-d radiotherapy plan 77301 Radiotherapy dose plan imrt 77301 radiotherapy dose plan imrt 77336 Radiation physics consult 77336 radiation physics consult 77338 Design mlc device for imrt 77338 design mlc device for imrt 77372 Srs linear based 77372 srs linear based 77373 Sbrt delivery 77373 sbrt delivery 77402 Radiation treatment delivery 77402 radiation treatment delivery 77403 Radiation treatment delivery 77403 radiation treatment delivery 77404 Radiation treatment delivery 77404 radiation treatment delivery 77406 Radiation treatment delivery 77406 radiation treatment delivery 77407 Radiation treatment delivery 77407 radiation treatment delivery 77408 Radiation treatment delivery 77408 radiation treatment delivery 77409 Radiation treatment delivery 77409 radiation treatment delivery 77411 Radiation treatment delivery 77411 radiation treatment delivery 77412 Radiation treatment delivery 77412 radiation treatment delivery 77413 Radiation treatment delivery 77413 radiation treatment delivery 77414 Radiation treatment delivery 77414 radiation treatment delivery 77416 Radiation treatment delivery 77416 radiation treatment delivery 77417 Radiology port film(s) 77417 radiology port film(s) 77600 Hyperthermia treatment 77600 hyperthermia treatment 77785 Hdr brachytx 1 channel 77785 hdr brachytx 1 channel 77786 Hdr brachytx 2-12 channel 77786 hdr brachytx 2-12 channel 77787 Hdr brachytx over 12 chan 77787 hdr brachytx over 12 chan 78072 Parathyrd planar w/spect&ct 78452 ht muscle image spect mult 88112 Cytopath cell enhance tech 88112 cytopath cell enhance tech 88365 Insitu hybridization (fish) 88365 insitu hybridization (fish) 88367 Insitu hybridization auto 88367 insitu hybridization auto 88368 Insitu hybridization manual 88368 insitu hybridization manual 90785 Psytx complex interactive 90836 psytx pt&/fam w/e&m 45 min 90791 Psych diagnostic evaluation 90846 family psytx w/o patient 90792 Psych diag eval w/med srvcs 90846 family psytx w/o patient 90832 Psytx pt&/family 30 minutes 90846 family psytx w/o patient

### CMS-1600-FC 473

CY 2014 New, Revised, or Potentially Misvalued HCPCS Code Malpractice Risk Factor Crosswalk HCPCS Code 90833 Psytx pt&/fam w/e&m 30 min 90846 family psytx w/o patient 90834 Psytx pt&/family 45 minutes 90846 family psytx w/o patient 90836 Psytx pt&/fam w/e&m 45 min 90846 family psytx w/o patient 90837 Psytx pt&/family 60 minutes 90846 family psytx w/o patient 90838 Psytx pt&/fam w/e&m 60 min 90846 family psytx w/o patient 90839 Psytx crisis initial 60 min 90837 psytx pt&/family 60 minutes 90840 Psytx crisis ea addl 30 min 90833 psytx pt&/fam w/e&m 30 min 90845 Psychoanalysis 90845 psychoanalysis 90846 Family psytx w/o patient 90846 family psytx w/o patient 90847 Family psytx w/patient 90847 family psytx w/patient 90853 Group psychotherapy 90853 group psychotherapy 91065 Breath hydrogen/methane test 91065 breath hydrogen/methane test 92521 Evaluation of speech fluenc y 96105 assessment of aphasia 92522 Evaluate speech production 96105 assessment of aphasia 92523 Speech sound lang comprehen 96105 assessment of aphasia 92524 Behavral qualit analys voice 92520 laryngeal function studies 93000 Electrocardiogram complete 93000 electrocardiogram complete 93005 Electrocardiogram tracing 93005 electrocardiogram tracing 93010 Electrocardiogram report 93010 electrocardiogram report 93582 Perq transcath closure pda 93580 transcath closure of asd 93583 Perq transcath septal reduxn 93580 transcath closure of asd 93880 Extracranial bilat study 93880 extracranial bilat study 93882 Extracranial uni/ltd study 93882 extracranial uni/ltd study 94667 Chest wall manipulation 94667 chest wall manipulation 94668 Chest wall manipulation 94668 chest wall manipulation 94669 Mechanical chest wall oscill 94668 chest wall manipulation 95816 Eeg awake and drowsy 95816 eeg awake and drowsy 95819 Eeg awake and asleep 95819 eeg awake and asleep 95822 Eeg coma or sleep only 95822 eeg coma or sleep only 95886 Musc test done w/n test comp 95886 musc test done w/n test comp 95887 Musc tst done w/n tst nonext 95887 musc tst done w/n tst nonext 95928 C motor evoked uppr limbs 95928 c motor evoked uppr limbs 95929 C motor evoked lwr limbs 95929 c motor evoked lwr limbs 96365 Ther/proph/diag iv inf init 96365 ther/proph/diag iv inf init 96366 Ther/proph/diag iv inf addon 96366 ther/proph/diag iv inf addon 96367 Tx/proph/dg addl seq iv inf 96367 tx/proph/dg addl seq iv inf

### CMS-1600-FC 474

CY 2014 New, Revised, or Potentially Misvalued HCPCS Code Malpractice Risk Factor Crosswalk HCPCS Code 96368 Ther/diag concurrent inf 96368 ther/diag concurrent inf 96413 Chemo iv infusion 1 hr 96413 chemo iv infusion 1 hr 96415 Chemo iv infusion addl hr 96415 chemo iv infusion addl hr 96417 Chemo iv infus each addl seq 96417 chemo iv infus each addl seq 98940 Chiropract manj 1-2 regions 98940 chiropract manj 1-2 regions 98941 Chiropract manj 3-4 regions 98941 chiropract manj 3-4 regions 98942 Chiropractic manj 5 regions 98942 chiropractic manj 5 regions 98943 Chiropract manj xtrspinl 1/> 98943 chiropract manj xtrspinl 1/> 99170 Anogenital exam child w imag 99170 anogenital exam child w imag 70450 26 Ct head/brain w/o dye 70450 26 ct head/brain w/o dye 70450 TC Ct head/brain w/o dye 70450 TC ct head/brain w/o dye 70460 26 Ct head/brain w/dye 70460 26 ct head/brain w/dye 70460 TC Ct head/brain w/dye 70460 TC ct head/brain w/dye 70551 26 Mri brain stem w/o dye 70551 26 mri brain stem w/o dye 70551 TC Mri brain stem w/o dye 70551 TC mri brain stem w/o dye 70552 26 Mri brain stem w/dye 70552 26 mri brain stem w/dye 70552 TC Mri brain stem w/dye 70552 TC mri brain stem w/dye 70553 26 Mri brain stem w/o & w/dye 70553 26 mri brain stem w/o & w/dye 70553 TC Mri brain stem w/o & w/dye 70553 tc mri brain stem w/o & w/dye 72141 26 Mri neck spine w/o dye 72141 26 mri neck spine w/o dye 72141 TC Mri neck spine w/o dye 72141 TC mri neck spine w/o dye 72142 26 Mri neck spine w/dye 72142 26 mri neck spine w/dye 72142 TC Mri neck spine w/dye 72142 TC mri neck spine w/dye 72146 26 Mri chest spine w/o dye 72146 26 mri chest spine w/o dye 72146 TC Mri chest spine w/o dye 72146 TC mri chest spine w/o dye 72147 26 Mri chest spine w/dye 72147 26 mri chest spine w/dye 72147 TC Mri chest spine w/dye 72147 TC mri chest spine w/dye 72148 26 Mri lumbar spine w/o dye 72148 26 mri lumbar spine w/o dye 72148 TC Mri lumbar spine w/o dye 72148 TC mri lumbar spine w/o dye 72149 26 Mri lumbar spine w/dye 72149 26 mri lumbar spine w/dye 72149 TC Mri lumbar spine w/dye 72149 TC mri lumbar spine w/dye 72156 26 Mri neck spine w/o & w/dye 72156 26 mri neck spine w/o & w/dye 72156 TC Mri neck spine w/o & w/dye 72156 TC mri neck spine w/o & w/dye 72157 26 Mri chest spine w/o & w/dye 72157 26 mri chest spine w/o & w/dye 72157 TC Mri chest spine w/o & w/dye 72157 TC mri chest spine w/o & w/dye 72158 26 Mri lumbar spine w/o & w/dye 72158 26 mri lumbar spine w/o & w/dye

### CMS-1600-FC 475

CY 2014 New, Revised, or Potentially Misvalued HCPCS Code Malpractice Risk Factor Crosswalk HCPCS Code 72158 TC Mri lumbar spine w/o & w/dye 72158 TC mri lumbar spine w/o & w/dye 72191 26 Ct angiograph pelv w/o&w/dye 72191 26 ct angiograph pelv w/o&w/dye 72191 TC Ct angiograph pelv w/o&w/dye 72191 TC ct angiograph pelv w/o&w/dye 74174 26 Ct angio abd&pelv w/o&w/dye 74174 26 ct angio abd&pelv w/o&w/dye 74174 TC Ct angio abd&pelv w/o&w/dye 74174 TC ct angio abd&pelv w/o&w/dye 74175 26 Ct angio abdom w/o & w/dye 74175 26 ct angio abdom w/o & w/dye 74175 TC Ct angio abdom w/o & w/dye 74175 TC ct angio abdom w/o & w/dye 77001 26 Fluoroguide for vein device 77001 26 fluoroguide for vein device 77001 TC Fluoroguide for vein device 77001 TC fluoroguide for vein device 77002 26 Needle localization by xray 77002 26 needle localization by xray 77002 TC Needle localization by xray 77002 TC needle localization by xray 77003 26 Fluoroguide for spine inject 77003 26 fluoroguide for spine inject 77003 TC Fluoroguide for spine inject 77003 TC fluoroguide for spine inject 77280 26 Set radiation therapy field 77280 26 set radiation therapy field 77280 TC Set radiation therapy field 77280 TC set radiation therapy field 77285 26 Set radiation therapy field 77285 26 set radiation therapy field 77285 TC Set radiation therapy field 77285 TC set radiation therapy field 77290 26 Set radiation therapy field 77290 26 set radiation therapy field 77290 TC Set radiation therapy field 77290 TC set radiation therapy field 77293 26 Respirator motion mgmt simul 77470 26 special radiation treatment 77293 TC Respirator motion mgmt simul 77470 TC special radiation treatment 77295 26 3-d radiotherapy plan 77295 26 3-d radiotherapy plan 77295 TC 3-d radiotherapy plan 77295 TC 3-d radiotherapy plan 77301 26 Radiotherapy dose plan imrt 77301 26 radiotherapy dose plan imrt 77301 TC Radiotherapy dose plan imrt 77301 TC radiotherapy dose plan imrt 77338 26 Design mlc device for imrt 77338 26 design mlc device for imrt 77338 TC Design mlc device for imrt 77338 TC design mlc device for imrt 77600 26 Hyperthermia treatment 77600 26 hyperthermia treatment 77600 TC Hyperthermia treatment 77600 TC hyperthermia treatment 77785 26 Hdr brachytx 1 channel 77785 26 hdr brachytx 1 channel 77785 TC Hdr brachytx 1 channel 77785 TC hdr brachytx 1 channel 77786 26 Hdr brachytx 2-12 channel 77786 26 hdr brachytx 2-12 channel 77786 TC Hdr brachytx 2-12 channel 77786 TC hdr brachytx 2-12 channel 77787 26 Hdr brachytx over 12 chan 77787 26 hdr brachytx over 12 chan 77787 TC Hdr brachytx over 12 chan 77787 TC hdr brachytx over 12 chan 88112 26 Cytopath cell enhance tech 88112 26 cytopath cell enhance tech

### CMS-1600-FC 476

CY 2014 New, Revised, or Potentially Misvalued HCPCS Code Malpractice Risk Factor Crosswalk HCPCS Code 88112 TC Cytopath cell enhance tech 88112 TC cytopath cell enhance tech 88365 26 Insitu hybridization (fish) 88365 26 insitu hybridization (fish) 88365 TC Insitu hybridization (fish) 88365 TC insitu hybridization (fish) 88367 26 Insitu hybridization auto 88367 26 insitu hybridization auto 88367 TC Insitu hybridization auto 88367 TC insitu hybridization auto 88368 26 Insitu hybridization manual 88368 26 insitu hybridization manual 88368 TC Insitu hybridization manual 88368 TC insitu hybridization manual 91065 26 Breath hydrogen/methane test 91065 26 breath hydrogen/methane test 91065 TC Breath hydrogen/methane test 91065 TC breath hydrogen/methane test 93880 26 Extracranial bilat study 93880 26 extracranial bilat study 93880 TC Extracranial bilat study 93880 TC extracranial bilat study 93882 26 Extracranial uni/ltd study 93882 26 extracranial uni/ltd study 93882 TC Extracranial uni/ltd study 93882 TC extracranial uni/ltd study 95816 26 Eeg awake and drowsy 95816 26 eeg awake and drowsy 95816 TC Eeg awake and drowsy 95816 TC eeg awake and drowsy 95819 26 Eeg awake and asleep 95819 26 eeg awake and asleep 95819 TC Eeg awake and asleep 95819 TC eeg awake and asleep 95822 26 Eeg coma or sleep only 95822 26 eeg coma or sleep only 95822 TC Eeg coma or sleep only 95822 TC eeg coma or sleep only 95928 26 C motor evoked uppr limbs 95928 26 c motor evoked uppr limbs 95928 TC C motor evoked uppr limbs 95928 TC c motor evoked uppr limbs 95929 26 C motor evoked lwr limbs 95929 26 c motor evoked lwr limbs 95929 TC C motor evoked lwr limbs 95929 TC c motor evoked lwr limbs

G0453 Cont intraop neuro monitor 95920 intraop nerve test add-on G0455 Fecal microbiota prep instil 9 1065 breath hydrogen/methane test G0461 Immunohistochemistry, init 88342 immunohisto antibody slide G0462 Immunohistochemistry, addl 88342 immunohisto antibody slide

### CMS-1600-FC 477

F. Geographic Practice Cost Indices (GPCIs) 1. Background Section 1848(e)(1)(A) of the Act requires us to develop separate Geographic Practice Cost Indices (GPCIs) to measure resource cost differences among localities compared to the national average for each of the three fee schedule components (that is , work, PE, and MP). The 89 total PFS localities are

discussed in section II.F.3. of this final rule with comment period. Although requiring that the PE and MP GPCIs reflect the full relative cost differences, section 1848(e)(1)(A)(iii) of the Act requires that the work GPCIs reflect only one-quarter of the relative cost differences compared to the national average. In addition, section 1848(e)(1)(G) of the Act sets a perman ent 1.5 work GPCI floor for services furnished in Alaska beginning January 1, 2009, and section 1848(e )(1)(I) of the Act sets a permanent 1.0 PE GPCI floor for services furnished in frontier states (as de fined in section 1848(e)(1)(I) of the Act) beginning January 1, 2011. Additionally, sec tion 1848(e)(1)(E) of the Act provided for a 1.0 floor for the work GPCIs, which was set to expire at the end of 2012. Section 602 of the ATRA amended the statute to extend the 1.0 floor for the work GPCIs through CY 2013 (that is, for services furnished no later than December 31, 2013). Section 1848(e)(1)(C) of the Act re quires us to review and, if necessary, adjust the GPCIs at least every 3 years. Section 1848(e)(1)(C) of the Act requir es that “if more than 1 y ear has elapsed since the date of the last previous GPCI adjustment, the adjust ment to be applied in the first year of the next adjustment shall be 1/2 of the adjustment that otherw ise would be made.” Therefore, since the previous GPCI update was implemented in CY 2011 and CY 2012, we proposed to phase in 1/2 of the latest GPCI adjustment in CY 2014. We completed a review of the GPCIs and proposed new GPCIs, as well as a revision to the cost share weights that correspond to all three GPCIs in the CY 2014 proposed rule. We also calculated a corresponding geographic adjustment factor (GAF ) for each PFS locality. The GAFs are a weighted composite of each area’s work, PE and MP GPCIs using the national GPCI cost share weights. Although the GAFs are not used in computing the fee schedule payment for a specific service, we provide them

### CMS-1600-FC 478

because they are useful in comparing overall areas co sts and payments. The actual effect on payment for any actual service will deviate from the GAF to the exte nt that the proportions of work, PE and MP RVUs

for the service differ from those of the GAF. As noted above, section 602 of the ATRA extended the 1.0 work GPCI floor only through December 31, 2013. Therefore, the proposed CY 2014 work GPCIs and summarized GAFs do not reflect the 1.0 work floor. However, as required by secti ons 1848(e)(1)(G) and 1848(e)(1)(I) of the Act, the 1.5

work GPCI floor for Alaska and the 1.0 PE GPCI floor for frontier states are permanent, and therefore, applicable in CY 2014 2. GPCI Update As discussed in the CY 2014 PFS proposed rule (78 FR 43322), the proposed updated GPCI values were calculated by a contractor to CMS. There are three GPCIs (work, PE, and MP), and all GPCIs are calculated through comparison to a national average for each type. Additionally, each of the three GPCIs relies on its own data source(s) and methodology for calculating its value as described below. Additional information on the proposed CY 2 014 GPCI update may be found in our contractor’s draft report, “Draft Report on the CY 2014 Update of the Geographic Practice Cost Index for the Medicare Physician Fee Schedule, ” which is available on the CMS website. It is located under the supporting documents section of the CY 2014 PFS proposed rule located at http://www.cms.gov/Medicare/Medicare-Fee-for-Ser vice-Payment/PhysicianFeeSched/PFS-FederalRegulation-Notices.html . Note: Our contractor’s final report and associated analysis will be posted on the CMS website after publication of this final rule w ith comment period (under the downloads section of the

CY 2014 PFS final rule.

a. Work GPCIs The physician work GPCIs are designed to refl ect the relative costs of physician labor by Medicare PFS locality. As required by statute, the physician work GPCI reflects one quarter of the relative wage differences for each locality compared to the national average.

### CMS-1600-FC 479

To calculate the physician work GPCIs, we use wage data for seven professional specialty occupation categories, adjusted to reflect one-quarter of the relative cost differences for each locality compared to the national average, as a proxy for phys icians’ wages. Physicia ns’ wages are not included in the occupation categories used in calculating th e work GPCI because Medicare payments are a key determinant of physicians’ earnings. Including physician wage data in calculating the work GPCIs would potentially introduce some circularity to the adjustment since Medicare payments typically contribute to or influence physician wages. That is, including p hysicians’ wages in the physician work GPCIs would, in effect, make the indices, to some extent, dependent upon Medicare payments. The physician work GPCI updates in CYs 2001, 2003, 2005, and 2008 were based on professional earnings data from the 2000 Census . However, for the CY 2011 GPCI update (75 FR 73252), the 2000 data were outdated and wage and ear nings data were not available from the more recent Census because the “long form” was discontinued. Therefore, we used the median hourly earnings from the 2006 through 2008 Bureau of Labor Statistics (BLS) Occupational Employment Statistics (OES) wage data as a replacement for th e 2000 Census data. The BLS OES da ta meet several criteria that we consider to be important for selecting a data source for purposes of calculating the GPCIs. For example, the BLS OES wage and employment data are derived from a large sample size of approximately 200,000 establishments of varying sizes nationwide from ev ery metropolitan area and can be easily accessible to the public at no cost. Additionally, the BLS OES is updated regularly, and includes a comprehensive set of occupations and industries (for exampl e, 800 occupations in 450 industries). Because of its reliability, public availability, level of detail, a nd national scope, we believe the BLS OES continues to be the most appropriate s ource of wage and employment data for use in calculating the work GPCIs (and as discussed in section II.F.2.b the employee wage component and purchased services component of the PE GPCI). Ther efore, for the proposed CY 2014 GPCI update, we used updated BLS OES data (2009 through 2011) as a replacement for the 2006 through 2008 data to compute the work GPCIs. b. Practice Expense GPCIs

### CMS-1600-FC 480

The PE GPCIs are designed to measure the relative cost difference in the mix of goods and services comprising practice expenses (not including malpractice expenses) among the PFS localities as compared to the national average of these costs. Whereas the physician work GPCIs (and as discussed later in this section, the MP GPCIs) are comprised of a single index, the PE GPCIs are comprised of four component indices (employee wages; purchased services; office rent; and equipment, supplies and other miscellaneous expenses). The employee wage inde x component measures geographic variation in the

cost of the kinds of skilled and unskilled labor that w ould be directly employed by a physician practice. Although the employee wage index adjusts for geographic variation in the cost of labor employed directly by physician practices, it does not account for geographi c variation in the cost of services that typically would be purchased from other entities, such as law firms, accounting firms, information technology consultants, building service managers, or any othe r third-party vendor. Th e purchased services index component of the PE GPCI (which is a separat e index from employee wages) measures geographic

variation in the cost of contracted services that physician practices would typi cally buy. (For more information on the development of the purchased ser vice index, we refer readers to the CY 2012 PFS final rule with comment period (76 FR 73084 through 73085).) The office rent index component of the PE GPCI measures relative geographic variation in the cost of typical physician office rents. For the medical equipment, supplies, and miscellaneous e xpenses component, we believe there is a national market for these items such that there is not signifi cant geographic variation in costs. Therefore, the “equipment, supplies and other miscellaneous expense” cost index component of the PE GPCI is given a value of 1.000 for each PFS locality. For the previous update to the GPCIs (impleme nted in CY 2011 and CY 2012) we used 2006 through 2008 BLS OES data to calculate the em ployee wage and purchased services indices for the PE GPCI. As we discussed in the propo sed rule because of its reliability, pub lic availability, level of detail, and national scope, we continue to believe the BLS OES is the most a ppropriate data source for collecting wage and employment data. Therefore, in calcu lating the proposed CY 2014 GPCI update, we used

### CMS-1600-FC 481

updated BLS OES data (2009 through 2011) as a re placement for the 2006 through 2008 data for purposes of calculating the employee wage component and purchased service index of the PE GPCI.

Office Rent Index Discussion Since the inception of the PFS, we have used resi dential rent data (primarily the two-bedroom residential apartment rent data produced by the De partment of Housing and Urban Development (HUD)

at the 50 th percentile) as the proxy to measure the relative cost difference in physician office rents. As

discussed in the CY 2012 PFS final rule with comment period (76 FR 73084), we had concerns with the

continued use of the HUD rental data because the da ta were not updated freque ntly and the Census “long form,” which was used to collect the necessary base year rents for the HUD Fair Market Rent (FMR) data, was discontinued in CY 2010 and would no longer be available for future updates. Therefore, we examined the suitability of using 3-year (2006-2008) U.S. Census Bureau American Community Survey (ACS) rental data as a proxy for physician office rent s to replace the HUD data. We determined that the ACS is one of the largest nationa lly representative surveys of hou sehold rents in the United States conducted annually by the U.S. Census Bureau, samp ling approximately 3 million addresses with a recent response rate above 97 percent, and th at it reports rental information for residences at the county level. Given that the ACS rental data provided a sufficien t degree of reliability, is updated annually, and was expected to be available for future updates, we u sed the 2006 through 2008 ACS 3-year residential rent data as a replacement for the HUD data to create the o ffice rent index for the CY 2012 PFS final rule with comment (76 FR 73084). For all the same reasons that we used the ACS data for the last GPCI update, we proposed to use updated ACS residential rent data (2008 through 2010) to calculate the office rent component of the PE GPCI. We noted in the propo sed rule that when responding to the ACS survey, individuals also report whether utilities are included in their rent. Thus, the cost of utilities cannot be separated from “gross rents” since some individuals mont hly rent also covers the cost of utilities. As discussed in section II.F.2.d., we combined the cost weights for fixed capital and utilities when assigning a proposed weight to the office rent component of the PE GPCI.

### CMS-1600-FC 482

For many years, we have received requests from st akeholders to use commercial rent data instead

of residential rent data to measure the relative cost di fferences in physician office rent. Additionally, in a report entitled “Geographic Adjustment in Medicare Payment, Phase I: Improving Accuracy, ” prepared for CMS under contract and released on September 28, 2011, the Institute of Medicine recommended that

“a new source of data should be developed to determine the variation in the price of commercial office rent per square foot.” The Institute of Medicine report did not identify any new data source and did not suggest how a new source of data might be deve loped. Because we could not identify a reliable

commercial rental data source that is available on a national basis and includes data for non-metropolitan areas, we continued to use residential rent data for the CY 2012 GPCI update. For the CY 2014 GPCI update, we continued our efforts to identify a reliable source of

commercial rent data that could be used in calculati ng the rent index. We could not identify a nationally representative commercial rent data source that is availa ble in the public sector. However, we identified a proprietary commercial rent data source that has poten tial for use in calculating the office rent indices in future years. To that end, we are attempting to nego tiate an agreement with the proprietor to use the data for purposes of calculating the office rent component of the PE GPCI. One of the challenges of using a proprietary da ta source is our ability to make information available to the public. When using government data, we are able to release all data for public consideration. However, when using a proprietary data source, it is likely that restrictions will be imposed on its use and our ability to disclose data. In such a situation, those wishing to replicate our

calculations based on detailed data would also need to purchase the underlying proprietary data. We also believe that, generally speaking, a proprietary “for profit” data source is more susceptible to periodic changes in the criteria used for data collection, in cluding possible changes in the data collected, the frequency at which the data is updated, changes in ow nership, and the potential for termination of the survey vehicle entirely as changes are made to addr ess economic pressures or opportunities. As such, we cannot predict that a given proprietary data source will be available in the format needed to develop office

rent indices in the future. Since we have not iden tified a nationally representative commercial rent data

### CMS-1600-FC 483

source that is available in the public sector, we belie ve it would be necessary to use a proprietary data source for commercial office rent data. That is, in the absence of using a proprietary data source, it is unlikely that we would be able to use commercial rent data to calculate the office rent index component of the PE GPCI. In the proposed rule we requested co mments on the use of a proprietary commercial rent data source as well as whether there is a source for these data that is not proprietary. c. Malpractice Expense (MP) GPCIs

The MP GPCIs measure the relative cost di fferences among PFS localities for the purchase of professional liability insurance (PLI). The MP GPCI s are calculated based on insurer rate filings of premium data for $1 million to $3 million mature clai ms-made policies (policies for claims made rather than services furnished during the policy term). Fo r the CY 2011 GPCI update (s ixth update) we used 2006 and 2007 malpractice premium data (75 FR 73256). The proposed CY 2014 MP GPCI update was developed using 2011 and 2012 premium data. Additionally, for the past several GPCI updates, we were not able to collect MP premium data from insurer rate filings for the Puerto Rico paym ent locality. For the CY 2014 (seventh) GPCI update, we worked directly with the Puerto Rico Insurance Commissioner and Ins titute of Statistics to obtain data on MP insurance premiums that were used to calcula te an updated MP GPCI for Puerto Rico. We noted in the proposed rule that using updated MP premium data would result in a 17 percent increase in MP GPCI for the Puerto Rico payment locality under the proposed fully phased-in seventh GPCI update,

which would be effective CY 2015. d. GPCI Cost Share Weights To determine the cost share weights for the pr oposed CY 2014 GPCIs, we used the weights we proposed to use for the CY 2014 value for the revi sed 2006-based MEI as discussed in section II.D. of this final rule with comment period. As discussed in detail in that section, the MEI was rebased and revised in the CY 2011 PFS final rule with comment period (75 FR 73262 through 73277) to reflect the weighted-average annual price change for various inputs needed to provide physicians’ services. We have historically updated the GPCI cost share wei ghts to make them consistent with the most recent

### CMS-1600-FC 484

update to the MEI, and proposed to do so again for CY 2014. We would note th at consistent with this approach, in the CY 2011 proposed rule, the last tim e the MEI was revised, we proposed to update the GPCI cost share weights to reflect these revisions to the MEI. However, in response to public comments we did not finalize the proposal in the CY 2011 PFS final rule with comment period (75 FR 73258 and 73260), so that we could explore public comments re ceived suggesting the rea llocation of labor related costs from the medical equipment, supplies and mis cellaneous component to the employee compensation component and comments received on the cost share wei ght for the rent index of the PE GPCI as well as to continue our analysis of the cost share weight s attributed to the PE GPCIs as required by section 1848(e)(1)(H)(iv) of the Act. In the CY 2012 PFS final rule (76 FR 73085 th rough 73086) we addressed commenter concerns regarding the inclusion of the cost share weight assi gned to utilities within the office rent component of the PE GPCI and to geographically adjust wage related industries contained within the medical equipment, supplies and miscellaneous component of th e PE GPCI. As a result, to accurately capture the utility measurement present in the ACS two bedroom gr oss rent data, the cost share weight for utilities was combined with the fixed capital portion to form th e office rent index. Additionally, we developed a purchased service index to geographically adjust the labor-related components of the “All Other Services” and “Other Professional Expenses” categories of the 2006-based MEI market basket. Upon completing our analysis of the GPCI cost share weights (as required by the Act) and addressing commenters’ concerns regarding the office rent and labor relate d industries previously contained in the medical equipment, supplies and other miscellaneous compone nts of the PE GCPI, we updated the GPCI cost share weights consistent with the weights establis hed in the 2006-based MEI in the CY 2012 PFS final rule (76 FR 73086). The proposed revised 2006-based MEI cost share we ights reflect our actuaries’ best estimate of the weights associated with each of the various inputs needed to provide physicians’ services. Use of the current MEI cost share weights also provides consiste ncy across the PFS in the use of this data. Given that we have addressed previous commenters’ concer ns about the allocation of labor related costs (as

### CMS-1600-FC 485

discussed earlier in this section) and that we have co mpleted our analysis of the GPCI cost share weights (as required by the Act) we proposed to adopt the we ights we proposed to use for the revised 2006-based MEI as the GPCI cost share weights for CY 2014. Specifically, we proposed to change the cost share weights for the work GPCI (as a percentage of the total) from 48.266 percent to 50.866 percent, and the cost share weight for the PE GPCI from 47.439 percent to 44.839 percent. In addition we proposed to change the employee compensation component of the PE GPCI from 19.153 to 16.553 percentage points. The proposed cost share weights for the office rent component (10.223 percent), purchased servi ces component (8.095 percent), and the medical equipment, supplies, and other miscellaneous expen ses component (9.968 percent) of the PE GPCI and the cost share weight for the MP GPCI (4.295 per cent) remained unchanged. A discussion of the specific MEI cost centers and the respectiv e weights used to calculate each GPCI component (and subcomponent) is provided below. (1) Work GPCIs We proposed to adopt the proposed revised weight of 50.866 for the physician compensation cost category as the proposed work GPCI cost share weight. (2) Practice Expense GPCIs For the cost share weight for the PE GPCIs, we used the revised 2006-based MEI proposed weight for the PE category of 49.134 percent minus the PLI category weight of 4.295 percent (because the relative costs differences in malpractice expenses are measured by its own GPCI). Therefore, the proposed cost share weight for the PE GPCIs is 44.839 percent. (a) Employee Compensation For the employee compensation portion of the PE GPCIs, we used the proposed non-physician employee compensation category weight of 16.553 pe rcent reflected in the revised 2006-based MEI. (b) Office Rent We set the PE GPCI office rent portion at 10.2 23 percent, which includes the proposed revised 2006-based MEI cost weights for fixed capital (reflec ting the expenses for rent, depreciation on medical

### CMS-1600-FC 486

buildings and mortgage interest) and utilities. As disc ussed previously in this section, we proposed to use 2008-2010 ACS rental data as the prox y for physician office rent. As mentioned previously, these data represent a gross rent amount and include data on utility expenditures. Since it is not possible to separate the utilities component of rent for all ACS survey respondents, we combined these two components to

calculate office rent values that we re used to calculate the office rent index component of the proposed PE GPCI. For purposes of consistency, we combined those two cost categories when assigning a proposed weight to the office rent component. (c) Purchased Services

As discussed in section II.A. of this final rule with comment period, to be consistent with the purchased services index, we proposed to combine th e current MEI cost share weights for “All Other Services” and “Other Professional Expenses” into a component called “All Other Professional Services.” The proposed weight for “All Other Professional Servi ces” is 8.095. As noted in the CY 2012 PFS final rule with comment period (76 FR 73084), we only adju st for locality cost differences of the labor-related share of the purchased services index. We determined that only 5.011 percentage points of the total 8.095 proposed weight are labor-re lated and, thus, would be adjusted for locality cost differences (5.011 adjusted purchased service + 3.084 non-adjusted pur chased services = 8.095 total cost share weight). Therefore, only 62 percent (5.011/8.095) of the purc hased service index is adjusted for geographic cost differences while the remaining 38 percent (3.084/8.095) of the purchased service index is not adjusted for geographic variation. (d) Equipment, Supplies, and Other Miscellaneous Expenses To calculate the medical equipment, supplies, and other miscellaneous expenses component, we removed PLI (4.295 percentage points), non-physi cian employee compensation (16.553 percentage points), fixed capital/utilities (10.223 percentage poi nts), and purchased services (8.095 percentage points) from the total proposed PE category weight (49. 134 percent). Therefore, the proposed cost share weight for the medical equipment, supplies, and other miscellaneous expenses component is 9.968 percent (49.134 – (4.295+16. 553 + 10.223 + 8.095) = 9.968). As explained above, because we

### CMS-1600-FC 487

believe there is a national market for these items, costs that fall within this component of the PE GPCI are not adjusted for geographic variation. (3) Malpractice GPCIs We proposed to use the PLI weight of 4.295 per cent for the MP GPCI cost share weight. The proposed GPCI cost share weights for CY 2014 are displayed in Table 31. TABLE 31: Proposed Cost Share Weights for CY 2014 GPCI Update

Expense Category Current Cost Share

Weight Proposed CY 2014 Cost Share

Weight Work 48.266% 50.866% Practice Expense (less PLI) 47.439% 44.839% - Employee Compensation 19.153% 16.553% - Office Rent 10.223% 10.223% - Purchased Services 8.095% 8.095% - Equipment, Supplies, Other 9.968% 9.968% Malpractice Insurance 4.295% 4.295% Total 100.000% 100.000%

e. PE GPCI Floor for Frontier States Section 10324(c) of the Affordable Care Act added a new subpa ragraph (I) under section 1848(e)(1) of the Act to establish a 1.0 PE GPCI floor for physicians’ services furnished in frontier States effective January 1, 2011. In accordance with sec tion 1848(e)(1)(I) of the Act, beginning in CY 2011, we applied a 1.0 PE GPCI floor for physicians’ services furn ished in states determined to be frontier states. In general, a frontier state is one in which at least 50 percent of the counties are “frontier counties,” which are those that have a population per square mile of less than 6. For more information on the criteria used to define a frontier state, we refer readers to the FY 2011 Inpatient Prospective Payment System final rule (75 FR 50160 through 50161). There are no chang es in the states identified as “frontier states” for CY 2014. The qualifying states are reflected in Table 32. In accordance with the Act, we will apply a 1.0

PE GPCI floor for these states in CY 2014.

### CMS-1600-FC 488

TABLE 32: Frontier States under Section 1848(E)(1)(I) of the Act (As added by section 10324(c) of the Affordable Care Act)

State Total Counties Frontier Counties Percent Frontier Counties (relative to counties in the State) Montana 56 45 80% Wyoming 23 17 74% North Dakota 53 36 68% Nevada 17 11 65% South Dakota 66 34 52%

f. Proposed GPCI Update As explained above, the periodic review and adjustment of GPCIs is mandated by section 1848(e)(1)(C) of the Act. At each update, the proposed GPCIs are published in the PFS proposed rule to provide an opportunity for public comment and furt her revisions in response to comments prior to implementation. The proposed CY 2014 updated GP CIs for the first and second year of the 2-year transition, along with the GAFs, were displayed in Addenda D and E to the CY 2014 proposed rule available on the CMS website under the supporting docu ments section of the CY 2014 PFS proposed rule web page at http://www.cms.gov/Medicare/Medicare-Fee-fo r-Service-Payment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html

. 3. Payment Locality Discussion a. Background The current PFS locality structure was developed a nd implemented in 1997. There are currently 89 total PFS localities; 34 localities are statewide areas (that is, only one locality for the entire state). There are 52 localities in the other 16 states, with 10 states having 2 localities, 2 states having 3 localities, 1 state having 4 localities, and 3 states having 5 or mo re localities. The District of Columbia, Maryland, and Virginia suburbs, Puerto Rico, and the Virgin Islands are additional localities that make up the remainder of the total of 89 localities. The developmen t of the current locality st ructure is described in detail in the CY 1997 PFS proposed rule (61 FR 346 15) and the subsequent final rule with comment period (61 FR 59494).

### CMS-1600-FC 489

Prior to 1992, Medicare payments for physic ians’ services were made under the reasonable charge system. Payments were based on the charging patterns of physicians. This resulted in large differences in payment for physicians’ services am ong types of services, geographic payment areas, and physician specialties. Recognizing this, the Congr ess replaced the reasonable charge system with the Medicare PFS in the Omnibus Budget Reconciliation Ac t (OBRA) of 1989, and the PFS went into effect January 1, 1992. Payments under the PFS are basedon the relative resources involved with furnishing services, and are adjusted to account for geographic variations in resource costs as measured by the

GPCIs. Payment localities originally were established under the reasonable charge system by local Medicare carriers based on their knowledge of local physician charging patterns and economic conditions. These localities changed little between the inception of Medicare in 1967 and the beginning of the PFS in 1992. Shortly after the PFS took effect, CMS unde rtook a study in 1994 that culminated in a comprehensive locality revision that w as implemented in 1997 (61 FR 59494). The revised locality structure reduced the number of localities from 210 to the current 89, and the

number of statewide localities increased from 22 to 34. The revised localities were based on locality resource cost differences as reflected by the GPCIs. For a full discussion of the methodology, see the CY 1997 PFS final rule with comment period (61 FR 594 94). The current 89 fee schedule areas are defined alternatively by state boundaries (for example, Wisco nsin), metropolitan areas (for example, Metropolitan St. Louis, MO), portions of a metropolitan area (for example, Manhattan), or rest-of-state areas that exclude metropolitan areas (for example, rest of Miss ouri). This locality configuration is used to

calculate the GPCIs that are in tu rn used to calculate payments for physicians’ services under the PFS.

As stated in the CY 2011 PFS final rule with comment period (75 FR 73261), we require that changes to the PFS locality structure be done in a budge t neutral manner within a state. For many years, before making any locality changes, we have sought consensus from among the professionals whose payments would be affected. In recent years, we ha ve also considered more comprehensive changes to locality configuration. In 2008, we issued a draft comprehensive report detaili ng four different locality

### CMS-1600-FC 490

configuration options ( www.cms.gov/physicianfeesched/downloads/ReviewOfAltGPCIs.pdf ). The alternative locality configurations in the report are described below.

● Option 1: CMS Core-Based Statistical Area (CBSA) Payment Locality Configuration : CBSAs are a combination of Office of Management and Budget (OMB’s) Metropolitan Statistical Areas (MSAs) and Micropolitan Statistical Areas. Under th is option, MSAs would be considered as urbanCBSAs. Micropolitan Statistical Areas (as defined by OMB) and rural areas would be considered as nonurban (rest of state) CBSAs. This approach would be consistent with the areas used in the Inpatient Prospective Payment System (IPPS) pre-reclassification wage index, which is th e hospital wage index for a geographic area (CBSA or non-CBSA) calculated from submitted hospital cost report data before statutory adjustments reconfigure, or “reclassify” a hos pital to an area other than its geographic location, to adjust payments for differences in local resour ce costs in other Medicare payment systems. Based on data used in the 2008 locality report, this opti on would increase the number of PFS localities from 89 to

439.

● Option 2: Separate High-Cost Counti es from Existing Localities (Separate Counties) : Under this approach, higher cost counties are removed from th eir existing locality structure, and they would each be placed into their own locality. This option wo uld increase the number of PFS localities from 89 to 214, using a 5 percent GAF differential to separate high-cost counties.

● Option 3: Separate MSAs from Statewide Localities (Separate MSAs) : This option begins with statewide localities and creates separate localities for higher cost MSAs (rather than removing higher cost counties from their existing locality as describ ed in Option 2). This option would increase the number of PFS localities from 89 to 130, using a 5 per cent GAF differential to separate high-cost MSAs.

● Option 4: Group Counties Within a State Into Locality Tiers Based on Costs (Statewide Tiers) : This option creates tiers of counties (within each stat e) that may or may not be contiguous but share similar practice costs. This option would increase the number of PFS localities from 89 to 140, using a 5 percent GAF differential to group similar counties into statewide tiers.

### CMS-1600-FC 491

For a detailed discussion of the public comments on the contractor’s 2008 draft report detailing four different locality configurations, we refer r eaders to the CY 2010 PFS proposed rule (74 FR 33534) and subsequent final rule with comment period (7 4 FR 61757). There was no public consensus on the options, although a number of commenters expressed support for Option 3 (separate MSAs from statewide localities) because the commenters believed this alternative would improve payment accuracy and could mitigate potential reductions to rural areas compared to Option 1 (CMS CBSAs). In response to some public comments regarding the third of the four locality options, we had our contractor conduct an analysis of the impacts that w ould result from the application of Option 3. Those results were displayed in the final locality re port released in 2011. The final report, entitled “ Review of Alternative GPCI Payment Locality Structures – Final Report, ” may be accessed directly from the CMS

website at www.cms.gov/PhysicianFeeSched/downloads/Alt_GP CI_Payment_Locality_Structures_Review.pdf

. Moreover, at our request, the Institute of Medici ne conducted a comprehensive empirical study of the Medicare GAFs established under sections 1848( e) (PFS GPCI) and 1886(d)(3)(E) (IPPS hospital wage index) of the Act. These adjustments are desi gned to ensure Medicare payments reflect differences in input costs across geographic areas. The first of the Institute of Medicine’s two reports entitled, “Geographic Adjustment in Medicare Payment, Phase I: Improving Accuracy ” recommended that the

same labor market definition should be used fo r both the hospital wage index and the physician geographic adjustment factor. Further, the Institute of Medicine recommended that MSAs and statewide non-metropolitan statistical areas should serve as the basis for defining these labor markets.

Under the Institute of Medicine’s recommenda tions, MSAs would be considered as urban CBSAs. Micropolitan Areas (as defined by the OMB) and rural areas would be considered as non-urban (rest of state) CBSAs. This approach would be consistent with the areas used in the IPPS prereclassification wage index to make geographic paymen t adjustments in other Medicare payment systems.

For more information on the Institute of Medicine ’s recommendations on the PFS locality structure, see the CY 2013 PFS final rule with comment period (77 FR 68949). We also provided our technical

### CMS-1600-FC 492

analyses of the Institute of Medicine Phase I reco mmendations in a report released on the PFS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Ser vice-Payment/PhysicianFeeSched/PFS-FederalRegulation-Notices.html

. Additionally, the Phase I report can be accessed on the Institute of Medicine's website at http://www.iom.edu/Reports/2011/Geographic-Adjust ment-in-Medicare-Payment-Phase-I-ImprovingAccuracy.aspx

. b. Institute of Medicine Phase II Report Discussion The Institute of Medicine’s second report, entitle d “Geographic Adjustment in Medicare Payment - Phase II: Implications for Access, Quality, and Efficiency ” was released July 17, 2012 and can be

accessed on the Institute of Medicine’s website at http://www.iom.edu/Reports/2011/GeographicAdjustment-in-Medicare-Payment-Phase-I-Improving-Accuracy.aspx

. The Phase II report evaluated the effects of geographi c adjustment factors (hospital wage index and GPCIs) on the distribution of the h ealth care workforce, quality of care , population health, and the ability to provide efficient, high value care. The Institute of Me dicine’s Phase II report also included an analysis of the impacts of implementing its recommendations for accu racy in geographic adjustments which include a CBSA-based locality structure under the PFS. The Ins titute of Medicine analysis found that adopting a CBSA-based locality structure under the PFS creates la rge changes in county GAF values; for example, approximately half of all US counties would experience a payment reduction. The Institute of Medicine also found that GPCIs calculated under a CBSA-based locality structure would result in lower GAFs in rural areas (relative to the national average) because the GP CI values for rural areas would no longer include metropolitan practice costs within the current “r est-of-state” or “statewide” localities. (1) Institute of Medicine Phase II Report Recommendations The Institute of Medicine developed recommendati ons for improving access to and quality of medical

care. The recommendations included in the Institu te of Medicine’s Phase II report are summarized as

follows:

### CMS-1600-FC 493

● Recommendation 1 : The Medicare program should develop and apply policies that promote access to primary care services in geographic areas where Medicare beneficiaries experience persistent access problems.

● Recommendation 2 : The Medicare program should pay for services that improve access to primary and specialty care for beneficiaries in medical ly underserved urban and rural areas, particularly telehealth technologies.

● Recommendation 3 : To promote access to appropriate and efficient primary care services, the Medicare program should support policies that would a llow all qualified practitioners to practice to the full extent of their educational preparation.

● Recommendation 4 : The Medicare program should reexamine its policies that provide location-based adjustments for specific groups of hos pitals, and modify or discontinue them based on their effectiveness in ensuring adequate access to appropriate care.

● Recommendation 5 : Congress should fund an independent ongoing entity, such as the National Health Care Workforce Commission, to su pport data collection, research, evaluations, and strategy development, and make actionable recomme ndations about workforce distribution, supply, and scope of practice.

● Recommendation 6 : Federal support should facilitate i ndependent external evaluations of ongoing workforce programs intended to provide access to adequate health services for underserved populations and Medicare beneficiaries. These progr ams include the National Health Services Corps, Title VII and VIII programs under the Public Health Service Act, and related programs intended to achieve these goals. (2) Institute of Medicine Phase II Report Conclusions

The Institute of Medicine committee concluded that geographic payment adjustments under the PFS are not a strong determinant of access problems and not an appropriate mechanism for improving the distribution of the healthcare workforce, quality of care, population health, and the ability to provide efficient, high value care. Specifically, the Institute of Medicine committee stated “that there are wide discrepancies in

### CMS-1600-FC 494

access to and quality of care across geographic areas partic ularly for racial and ethnic minorities. However, the variations do not appear to be strongly related to differences in or potential changes to fee for service payment” (Page. 6). The committee also concluded “t hat Medicare beneficiaries in some geographic pockets face persistent access and quality problems, and many of these pockets are in medically underserved rural and inner-city areas. However, geographic adjustment of Medicare payment is not an appropriate approach for addressing problems in the supply and distribution of the h ealth care workforce. The geographic variations in the distribution of physicians, nurses and physician assistants, and local shortages that create access problems for beneficiaries should be addressed through other means” (Page 7). Moreover, the committee concluded that “geographic [payment] adjustment is not an appr opriate tool for achieving policy goals such as improving quality of expanding the pool of pr oviders available to see Medicare beneficiaries” (Page 9). (3) CMS Summary Response to Ins titute of Medicine Phase II Report The Institute of Medicine’s Phase II report reco mmendations are broad in scope, do not propose specific recommendations for making changes to the GP CIs or PFS locality structure, or are beyond the statutory authority of CMS. We agree with the Institute of Medicine’s ass essment that many counties would experience a payment reduction and that large payment shifts w ould occur as a result of implementing a CBSA-based locality configuration under the PFS. Based on our c ontractor’s analysis, there would be significant redistributive impacts if we were to implement a policy that would reconfigure the PFS localities based on

the Institute of Medicine’s CBSA-based loca lity recommendation. Many rural areas would see substantial decreases in their corresponding GAF and GPCI values as higher cost counties are removed from current “rest of state” payment areas. Conversely, many urban areas, especially those areas that are currently designated as “rest of state” but are locat ed within higher cost MSAs, would experience increases in their applicable GPCIs and GAFs. That is, given that urban and rural areas would no longer be grouped together (for example, as in the current 34 statewide localities), many rural areas would see a reduction in payment under a CBSA-ba sed locality configuration.

### CMS-1600-FC 495

As noted earlier in this section, we are assessing a variety of approaches to changing the locality structure under the PFS and will continue to study options for revising the locality structure. However, to fully assess the implications of proposing a nationwide lo cality reconfiguration under the PFS, we must also assess and analyze the operational changes necessary to impl ement a revised locality structure. Given that all options under consideration (including the Institute of Medicine’s CBSA- based approach) would expand the number of current localities and result in payment re ductions to primarily rural areas, presumably any nationwide locality reconfiguration co uld potentially be trans itioned over a number of years (to phase-in the impact of payment reductions graduall y, from year-to-year, instead of all at once). As such, transitioning from the current locality structure to a nationwide reconfigured locality structure would present operational and administrative challenges that need to be iden tified and addressed. Therefore, we have begun to assess the broad operational changes that would be involved in implementing a nationwide locality reconfiguration under the PFS. Accordingly, we believe that it would be premature to make any statements about potential changes we would consider making to the PFS localities at this time. Any changes to PFS fee schedule areas would be made through future notice and comment rulemaking. The following is a summary of the comments we received regarding our proposed CY 2014 GPCI update and summary response to the Institute of Medicine’s Phase II report recommendations.

Comment : A few commenters including a national medical association and state medical society expressed support for using more current data in calcu lating the GPCIs. Another commenter stated that the BLS OES provides the best data for calculating the work GPCI and the employee wage component and purchased service component of the PE GPCI. Response : For the reasons outlined in the proposed rule, we agree with the commenters.

Comment : One state medical association expressed support for our proposal to use BLS OES data for calculating the geographic variation in physic ian work. The commenter stated that the BLS OES includes a large sample of data on wages and should be very reliable. Howeve r, the commenter raised concerns about using multi-year averages of wages in years that large demographic and economic changes may have occurred. The commenter contends that because the BLS OES data are so robust,

### CMS-1600-FC 496

using three-year averages is not necessary or appropr iate. The commenter suggested that GPCI updates

based on BLS OES data should be based on the most r ecent annual data available, rather than multi-year

averages. Response : We agree with the commenter that the B LS OES data are a reliable and robust source of wage and earnings data. The BLS OES wage a nd earnings data released in any given year are aggregated using 6 semi-annual panels of data collect ed over 3 years (2 panels per year). The BLS does not produce 1-year wage and earnings data. Acco rding to the Occupational Employment Statistics Frequently Asked Questions: “Significant reduc tions in sampling error can be achieved by taking advantage of a full 3 years of data, covering 1.2 million establishments and about 62 percent of the employment in the United States. This feature is particularly important in improving the reliability of estimates for detailed occupations in small geographical areas. Combining multiple years of data is also necessary to obtain full coverage of the largest estab lishments. In order to reduce respondent burden, the OES survey samples these establishments with virtual certainty only once every three years.” We also note that the BLS recognizes that labor costs change over time. To make the data from all 6 semi-annual panels comparable, the OES program uses the Employme nt Cost Index (ECI) to translate the occupationlevel wages from previous years into a wage num ber for the most recent year. The Occupational Employment Statistics Frequently Asked Questions may be accessed from the Bureau of Labor Statistics

website at: http://www.bls.gov/oes/oes_ques.htm . As discussed above, the OES FAQs explain that the use of multi-year averages improves reliability of the da ta and reduces sampling error. We agree with this assessment, and therefore, we will continue to use the BLS OES wage and earnings data that reflect multi-year averaging.

Comment : A few commenters stated that the proposed GPCI update results in lowering payment amounts to rural areas, which threatens patient acc ess to physician services, including treatments for complex conditions such as cancer and lupus. Another commenter expressed support for the elimination of all geographic adjustment factors under the PFS. The commenter believes that lower GPCIs discourage physicians and practitioners from practicing in rural and underserved areas.

### CMS-1600-FC 497

Response : As discussed previously, section 1848(e)(1 )(A) of the Act requires us to develop separate GPCIs to measure resource cost differen ces among localities compared to the national average for each of the three fee schedule components. We do not have the authority to eliminate geographic payment adjustments under the PFS. We note that the GPCI values for many rural PFS areas, including many single state localities (and rest of state loca lities), will increase as a result of the CY 2014 GPCI update. However, because the statutory 1.0 work GP CI floor expires at the end of CY 2013, beginning January 1, 2014, PFS payment amounts will be calcu lated based upon the actual work GPCI for the locality rather than using the 1.0 work GPCI floor (except in Alaska where the statutory 1.5 work GPCI floor will continue to apply). Accordingly, th e summarized GAFs, provided as noted above for purposes of illustration and comparison, demonstrate decreases in the work GPCIs for th ese same PFS localities.

Comment : A few commenters requested an extension of the statutorily-mandated 1.0 work GPCI floor, which expires on December 31, 2013. Response : As discussed above, the 1.0 work GPCI floor is established by statute and expires on December 31, 2013. We do not have authority to extend the 1.0 work GPCI floor beyond December 31,

2013.

Comment : A few commenters urged us to reassess the professional occupational categories used to determine the relative cost differences in physicia n earnings for purposes of calculating the work GPCI. The commenters believe that the current inputs do not adequately measure the relative cost differences in physician salary across PFS localities. The comment ers also mentioned a recent report published by MedPAC on the work GPCI, which recommended changes to the proxy occupations used in calculating

the work GPCI. The commenters stated that the MedP AC study found that the data sources we currently rely upon for determining the work GPCI bear no corr elation to physician earnings and that rural primary care physicians have higher wages than their urban co unterparts. One commenter suggested that we use actual physician salaries (instead of proxy occupations ) to determine the relative differences in physician wages. Another commenter urged us to modify the work GPCI to include “reference occupations that will accurately reflect the higher input costs of rural physician earnings.”

### CMS-1600-FC 498

Response : We appreciate the comments regarding the professional occupations used to determine the relative cost differences in physician earnings for purposes of calculating the work GPCI. As noted previously in this section, physi cians’ wages are not included in the occupation categories used in calculating the work GPCI because Medicare payments are a key determinant of physicians’ earnings. Including physician wage data in calculating the work GPCIs would potentially introduce some circularity to the adjustment since Medicare paymen ts typically contribute to or influence physician wages. In other words, including physicians’ wages in the physician work GPCIs would, in effect, make the indices, to some extent, dependent upon Medicare payments, which in turn are affected by the indices. Additionally, as noted in the proposed rule the Me dPAC was required by section 3004 of the MCTRJCA to submit a report to the Congress by June 15, 2013, assessing whether any adjustment under section 1848 of the Act to distinguish the difference in work effort by geographic area is appropriate and, if so, what that level should be and where it should be applied. In the report, MedPAC was required to also assess the impact of the work geographic adjustment under the Act, including the extent to which the floor on such adjustment impacts access to care. We also noted in the proposed rule that we did not have sufficient time to review this report, which was issu ed on June 14, 2013, in order to take the report into consideration for the proposed rule. We will be assessing the findings and recommendations from the MedPAC report and, and we will consider whether to make recommendations or proposals for changes in future rulemaking.

Comment : Several commenters noted that they a ppreciated our efforts to obtain more recent malpractice premium data from Puerto Rico for pur poses of calculating the MP GPCIs. The commenters stated that a MP GPCI update for the Puerto Rico payment locality is long overdue. Response : We agree with the commenters. By obtaining more recent malpractice premium insurance data, we were able to calculate an updated MP GPCI for the Puerto Rico payment locality using recent market share and rate filings data, as we we re able to do for most other PFS localities.

### CMS-1600-FC 499

Comment : One commenter stated that we did not use the most recent ACS residential rent data available (2009 through 2011) when calculating the rent index and encouraged us to use the most recent

ACS residential rent data if it does not decrease the PE GPCI for Puerto Rico. Response : We appreciate the commenter’s suggestion to use 2009 through 2011 ACS data for the CY 2014 GPCI update. We note that there was insuffi cient time between the release of the 2009 through 2011 ACS data and the CY 2014 PFS proposed rule to a llow us to use these data for the calculation of the proposed office rent component of the PE GPCI.

Comment : Many commenters requested an increase to the PE GPCI values for the Puerto Rico payment locality. The commenters believe it is necessar y to increase payments to Puerto Rico to prevent the continued exodus of physicians to the U.S. mainla nd, as well as to maintain the quality of care, reflect inflation, and modernize equipment and supplies in Pu erto Rico. The commenters also argue that doctors in Puerto Rico are required to provide the same servi ces for lower reimbursement than those practicing in the U.S. mainland). One commenter acknowledged that the work, PE an d malpractice GPCIs for the Puerto Rico locality were increased as a result of the CY 2014 GPCI update, but noted that, even with the increases, Puerto Rico continues to be the lowest paid PFS lo cality and that its “neighboring locality,” the Virgin Islands, unjustifiably receives a MP GPCI and PE GPCI of 1.0. The commenter also requested specific increases to the proposed PE GPCI fo r the Puerto Rico locality, most notably the rent component and medical equipment and supplies component, and refere nced a previous study entitled “Cost of Medical Services in Puerto Rico,” which included physic ian survey information on the costs of operating a medical practice in Puerto Rico. In addition, the same commenter stated that the methodology u sed to determine the equipment and supplies component of the PE GPCI is unfair to Puerto Rico. For example, the commenter noted that the medical equipment and supplies component of the PE GPCI is currently not adjusted for geographic cost differences; therefore all PFS localities receive an index of 1.0 for the equipment and supplies component. The commenter stated that medical equipm ent and supplies cost more in Puerto Rico because

### CMS-1600-FC 500

of the higher cost of shipping, noting, for example, that air and maritime shipping is more expensive than ground shipping. Because Puerto Rico is depende nt on air and maritime shipping, the commenter believes that our presumption that most medical equipment and supplies are sold through a national market does not adequately capture the higher cost of shipping medical equipment and medical supplies to the Puerto Rico locality. The commenter urged us to increase the PE GPCI calculated for the Puerto Rico locality, “so that it is equal to, or more clo sely approximates, the PE GPCI calculated for the state with the lowest PE GPCI (in this case, West Virginia).” Response : As noted previously in this section, we are required by section 1848(e)(1)(A) of the Act to develop separate GPCIs to measure relative re source cost differences among localities compared to the national average for each of the three fee sc hedule components: work, PE and MP expense and to update the GPCIs at least every 3 years. In the CY 2014 PFS proposed rule, we proposed to update the GPCIs for each Medicare PFS locality using updated data. For the CY 2014 GPCI update, we calculated updated GPCIs for the Puerto Rico locality using the same data sources and methodology as used for

other PFS localities. To calculate the work GPCI and the employee compensation and purchased service components of the PE GPCI, we used 2009 through 2011 BLS OES data. To calculate the office rent component of the PE GPCI we used updated ACS data (2008 through 2010) as replacement for 2006 through 2008. With respect to the comment s uggesting we assign the PE GPCI calculated for West Virginia to the Puerto Rico payment locality, we not e that we are required to calculate GPCIs based upon the geographic cost differences between a specific PF S payment locality and the national average. As noted above, we have sufficient cost data to calcula te GPCI values specific to the Puerto Rico payment locality. It would not be appropriate to assign a PE GPCI calculated for the West Virginia payment locality (based on data specific to West Virginia) to the Puerto Rico payment lo cality. Additionally, with respect to the comment on the differential between the GPCI values assigned to the Virgin Islands payment locality (as compared to the calculated GPCI values for the Puerto Rico payment locality), we note that when a locality has sufficien t locality-specific data, we use those data to calculate GPCI values according to the established methodology. Given that th ere are sufficient locality-specific data for Puerto

### CMS-1600-FC 501

Rico, we calculated the GPCI values for the Puerto Rico payment locality based upon data from Puerto

Rico. As previously mentioned, we continue to belie ve that the BLS OES and ACS are reliable data sources for measuring the relative cost differences in wages and rents. In preparation for the CY 2014 GPCI update, we reviewed the study previously su bmitted by stakeholders entitled “Cost of Medical Services in Puerto Rico.” The study aimed to analyze medical practice costs as well as physicians’ perceptions of cost trends in Puerto Rico. Broadly, many of the study’s findings are not directly relevant to the GPCIs because the study largel y measured increases in the cost of practicing medicine in the Puerto Rico locality over time, but did not compare Puerto Ri co cost trends to those across other PFS localities. We note that updates to the GPCIs are based upon cha nges in the relative costs of operating a medical practice among all PFS localities and not changes in th e costs within a specific locality. Further, the survey methodology did not claim to be representative of all physicians furnishing services in the Puerto Rico payment locality. The physician responses do not appear to be weighted to represent the population of physicians across the Puerto Rico payment locality. Moreover, the study claimed (as did many of th e commenters) that shipping and transportation expenses increase the cost of medical equipment and supplies in Puerto Rico relative to the U.S. mainland. In developing the proposed CY 2014 GPCI update, we evaluated the premise that Puerto Rico physicians incur higher shipping costs when purchasi ng medical equipment and supplies that should be reflected in the GPCIs. At our request, our cont ractor attempted to locate data sources specific to geographic variation in shipping costs for medical equipment and supplies. However, there does not appear to be a comprehensive national data source availa ble. In light of the comment that shipping costs are more expensive for the Puerto Ri co payment locality (and rural areas, as discussed later in this section by other commenters) we are requesting specific info rmation regarding potential data sources for shipping costs for medical equipment and supplies that are ac cessible to the public, available on a national basis for both urban and rural areas, and updated regularly

### CMS-1600-FC 502

Comment : One commenter asserted that reside ntial rents are an inaccurate proxy for commercial (office) rents in Puerto Rico because the residential rental market is less developed in Puerto Rico as compared to the commercial re ntal market. The commenter noted that Puerto Rico’s residential rental market is largely skewed towards the very low (and extremely low) end of the income scale. For example, the commenter st ated that 30 percent of renters in Puerto Rico are subsidized by a HUD program, compared to a national average of about 12 percent. The

commenter also mentioned that the ACS residentia l rent data (which are used to calculate the office rent index) includes utilitie s. The commenter stated that the cost of one utility, electricity, in Puerto Rico, is more than double the national average. However, the commenter believes the high cost of electricity and other utilities that physicians in Puerto Rico incur is not adequately captured in the ACS residential rental data, because nearly one third of all the renters in Puerto Rico receive utility allowances and therefore are not responsib le for their utility costs. Response : The ACS is designed to capture the tota l actual costs of bot h rent and utilities (i.e. gross rent) regardless of whether either or both are subsidized and regardless of whether utility costs are included in rent or paid separately. According to the American Community Survey and Puerto Rico Community Survey (PRCS ) 2010 Subject Definitions: “Gross rent is the contract rent plus the estimated average monthly co st of utilities (electri city, gas, and water and sewer) and fuels (oils, coal, kerose ne, wood, etc.) if these are paid by the renter (or paid for the renter by someone else).” (Page 17.) The rent porti on of gross rent is “the monthly rent agreed to or contracted for, regardless of any furnishings, utilities, fees, meals, or services that may be included.” (Page 15.) Contract rent data were obt ained from Housing Question 15a of the 2010 American Community Survey and Puerto Rico Co mmunity Survey. Utility costs included in the rent payment were also captured in this question while utility costs paid se parately from contract

### CMS-1600-FC 503

rent were obtained from a different set of questions in the survey. For instance, according to the American Community Survey and Puerto Rico Community Survey 2010 Subject Definitions: “The data on utility costs were obtained fr om Housing Questions 11a through 11d in the 2010 American Community Survey. The questions we re asked of occupied housing units. The questions about electricity a nd gas asked for the monthly co sts, and the questions about water/sewer and other fuels (oil, coal, wood, kerosene, etc.) asked fo r the yearly costs. Costs are recorded if paid by or billed to occupants, a welfare agency, relatives, or friends [emphasis added]. Costs that are paid by landlords, in cluded in the rent payment, or included in condominium or cooperative fees are excluded” (Pag e 37). Therefore, it is correct to say the

ACS estimates of residential rent and utility costs account for subsid ized utilities. The American Community Survey and Puerto Rico Community Survey 2010 S ubject Definitions publication may be accessed from the Bureau of Census website at http://www.census.gov/acs/www/Downloads/data _documentation/SubjectDefinitions/2010_ACS SubjectDefinitions.pdf.

Comment : One commenter stated that “our re gion’s office rental rates are, by GPCI measurement, supposedly only one-third of the highest (cost) regions” and that Medical Group Management Association (MGMA) survey data do not support these findings. The commenter requested that relative cost differences be accu rately determined before making any adjustment

to the PE GPCI. Response : We do not believe the MGMA rental information on physician office rent is an adequate source for calculating the office re nt index component of the PE GPCI for the following reasons. First, al though MGMA invites about 11,000 me dical practices to complete each of the two surveys it conducts (cost survey and compensation survey), the response rates for

### CMS-1600-FC 504

these surveys are typically belo w 20 percent and responses primarily capture information for physician practices operating in metropolitan area s. Second, in addition to the low response rates, MGMA has uneven response rates across re gions due to the fact that MGMA relies on a convenience sample rather than a random sample. For example, almost twice as many Colorado practices completed the surveys compared to those in California; the survey also includes more provider responses from Minnesota (ranked 21 st 

### in population) than any other state. Finally, there are few observations for many small states ; in fact, ten states have fewer than 10

observations each. For the reasons discussed above, we do not be lieve the MGMA survey is a viable data source for determining the relative cost differences in rents across PFS localities. As discussed previously in this section, gi ven its national representation, re liability, high response rate and frequent updates we continue to believe that the ACS residential re nt data is the most appropriate data source available at this time for purposes of calculating the rent index of the PE GPCI.

Comment : We received mixed comments regarding the potential use of a proprietary commercial rent data source for purposes of calcu lating the rent index of the PE GPCI. For instance, a few commenters stated that we should continue to e xplore the possibility of using a commercial rent data source (but did not comment specifically on the potential use of proprietary data). One medical association stated that it would be helpful if we could “elucidate how incorporating the commercial rent data would impact the practice expense GPCI and payment rates in each Medicare payment locality.” In contrast, three other commenters did not support the use of a proprietary commercia l rent data source and urged us to continue using publicly available data. One association suggested th at we “should use the most accurate publicly available datasets to set the GPCI adjustments ...because...it is important for the public to have

### CMS-1600-FC 505

an opportunity to comment on proposed changes, a nd they need access to information to provide meaningful comments.” Another co mmenter stated that there is not a more reliable source of data for calculating physician office rents (than th e ACS residential rent data) and that the ACS data serve as a reasonable proxy for the relative di fferences in rents across PFS localities. The same commenter expressed concer n about the cost to the public of purchasing proprietary data and suggested that a commercial rent data sour ce might be used to validate relative cost

differences calculated from the ACS data (but not replace the ACS data). Response : We appreciate the comments receive d on the potential use of a proprietary

commercial rent data source. In the event we make a specific proposal to incorporate a commercial rent data source (either proprietary or publicly available) for calculating the office rent index of the PE GPCI, we would provide locality level impacts of such proposal and the opportunity for public comment as afford ed through the rulemaking process.

Comment : A few commenters supported the conti nuation of the 1.0 PE GPCI floor for

frontier states. Response : The 1.0 PE GPCI floor will continue to be applied for states identified as

“frontier states” in accordance with 1848(e)(1)( I) of the Act.

Comment : Two commenters stated that many rural areas that do not fall within the statutory definition of a frontier state also face challenges associated with patient access to “physician-furnished services.” The commenters stat ed that, even if the 1.0 work GPCI floor is extended, the updates to the PE GPCIs disadvantage rural providers, most notably in the provision of drugs and biologicals administered in a physician’s office. The commenters assert that rural practices have “low purchasing power” (because of lower patient volumes) and higher shipping costs (in comparison to urban areas). The same commenters urged us to take into

### CMS-1600-FC 506

account the “unique challenges faced by rural phys icians in non-designated frontier states” and to fully recognize the significant costs of pr oviding health care in rural communities when updating the GPCIs. Response : We appreciate the comments received on the PE GPCI for rural areas. As discussed previously in this sec tion, we are required to update the GPCIs at least every 3 years to

reflect the relative cost differen ces of operating a medical practice in each locality compared to the national average costs. We do not have authority to apply th e 1.0 PE GPCI floor to states that do not meet the statutory definition of a fron tier state. As discussed above in response to another commenter, we are reque sting specific information regard ing potential data sources for shipping costs for medical equipment and suppl ies – especially sour ces that are publicly available, collect data nationally with sufficient coverage in both urban and rural areas, and are updated at regular intervals.

Comment : Several state medical associations strongly opposed the proposed revised 2006- based MEI that moved compensation for nonphysicia n practitioners from the practice expense category to the physician compensation category, a nd the implications of that proposed change for the GPCIs. Because of those concerns, th e commenters strongly objected to our proposal to update the GPCI cost share weights to make them consistent with the most recent update to the MEI. Additionally, the commenter s expressed concern that the pr oposed changes in cost share weights used in calculating updated GPCIs woul d alone cause signifi cant changes in CY 2014 PFS payment amounts. Response : As discussed in section II.B. revisions to the MEI are used to adjust the RVUs under the PFS so that the work RVUs and PE RVUs (in the aggregate) are in the same proportions as in the MEI. We also make the n ecessary adjustments to achieve budget neutrality

### CMS-1600-FC 507

for the year under the PFS. A discussion of how our adoption of the proposed MEI cost weight revisions affects the adjustment of work RVUs and PE RVUs is provided in section II.B. of this final rule with comment period. With regard to the GPCIs, as noted in s ection II.F.2.d., we histori cally have updated the GPCI cost share weights (and more generally, as noted above, the RVUs under the PFS) to make them consistent with the most recent update to the MEI because the MEI cost share weights

reflect our actuaries’ best estimate of the wei ghts associated with each of the various inputs needed to provide physician services. Use of th e revised MEI weights for purposes of the GPCIs does not represent a change to the data sources or methodology used to calcu late the GPCIs. For purposes of calculating GPCI values, the revise d MEI weights only result in changes to the relative weighting within the PE GPCI (because there are no subcomponent cost share weights for the work GPCI or malpractice GPCI). Si nce the MEI weight only changed for the employee compensation subcomponent (for instance, the ME I weights for office rent, purchased services and equipment and supplies remained unchanged), th e revised MEI affected the relative weight of all PE subcomponents (as a percentage of total PE GPCI). In other words, using the revised MEI cost share weights results in a lower wei ght for the employee compensation component as a percentage of the total PE GPCI and higher we ights for office rents, purchased services, and medical equipment and supplies as a percentage of the total PE GPCI. Use of the revised MEI cost share weights has no implications for cal culating the work GPCI values or malpractice GPCI values. Thus, we believe the comments on our proposal to adopt the revised 2006-based MEI weights predominately reflect concerns about the impact of th e revised weights in terms of

RVU redistribution and conversion factor adjustment, which is discussed in section II.B.2.f.,

rather than on their use in the calculation of GPCI values. An analysis is olating the impact of the

### CMS-1600-FC 508

changes in the subcomponent weighting of the PE GPCIs is available on the CMS website under the supporting documents section of th e CY 2014 PFS final rule web page at http://www.cms.gov/Medicare/Medicare-Fee-for-Ser vice-Payment/PhysicianFeeSched/PFS-FederalRegulation-Notices.html



### . We note that the MEI cost share weights are also used to calculate a geographic adjustment factor (GAF) for each PFS locality, weighting each locality’s GPCIs (work, PE, and MP) by the corresponding na tional MEI cost share weight. Ho wever, as mentioned previously, we calculate the GAFs for purposes of comp aring the approximate aggregate geographic payment adjustments among localities. The GAF is not used to calculate the geographically adjusted payment amount for individual services . Rather, the geographically adjusted payment amount is calculated by applying th e actual GPCI values (for wor k, PE and malpractice) for the particular PFS locality to adjust the RVUs (for work, PE and MP) for a specific service.

Comment : A few national medical associations requested that CMS respond to the

Institute of Medicine’s “Recommendation 3” as contained in its Phase II report. The

commenters noted that the Institu te of Medicine recommended th at the Medicare program should support policies that would allow al l qualified practitioners to practi ce to the full ex tent of their educational preparation. The commenters believe “that there are numerous barriers in Medicare regulations, procedures, and instru ctions that prevent nurse practit ioners and other health care providers from performing the full range of services they are educated and clinically prepared to deliver.” However, the commenter did not provide specific examples as part of their submitted comments on the CY 2014 PFS proposed rule. More over, the commenter urged us to develop proposals to revise Medicare regul ations and policies to address the need for primary care, including women’s health and pediat ric services, in underserved areas.

### CMS-1600-FC 509

Response : The Institute of Medicine’s Phase II report summary analysis indicates: “there are many inconsistencies in state laws regardin g scope of practice and many NPs are more likely

to locate in rural areas in states with mo re progressive, less restrictive regulations.” Additionally, the Institute of Medicine recommende d that “given the shortage of primary care providers in the United States and specifically in rural areas, the committee agrees that it would

be reasonable to remove barriers in Medica re and state licensing la nguage so all qualified practitioners are able to practi ce to the full extent of their ed ucational preparation in providing needed services for Medicare beneficiaries” (P age 10). We did not include any proposals based

on this Institute of Medicine recommendation in the CY 2014 PFS proposed rule. Therefore, we believe the comments relating to this recommendation are beyond the scope of the CY 2014 PFS proposed rule.

Comment : We received several comments on the PFS locality structure that were not within the scope of the CY 2014 proposed rule. For example, several commenters requested a locality change for a specific c ounty. Another commenter reque sted that we consider the operational impact of a locality reconfigura tion on the provider co mmunity, including nonphysician practitioners, before making changes to the PFS locality structure. Two state medical associations emphasized the need to reform PFS localities, preferring an MSA-based approach. One national association was opposed to local ity changes resulting in payment reductions to rural areas and a rural physicia n clinic recommended that we do not make any changes to the PFS locality structure because increasing the number of localities would lo wer payments to rural physicians. Response : We appreciate the suggestions for making revisions to the PFS locality structure. As discussed above, we did not pr opose changes to the PFS lo cality structure.

### CMS-1600-FC 510

Result of Evaluation of Comments

After consideration of the public comments received on the CY 2014 GPCI update, we are finalizing the CY 2014 GPCI update as prop osed. Specifically, we are using updated BLS OES data (2009 through 2011) as a replacement for 2006 through 2008 data for purposes of calculating the work GPCI and the employee co mpensation component and purchased services component of the PE GPCI. We are also us ing updated ACS data (2008 through 2010) as a replacement for 2006 through 2008 data for calculat ing the office rent component of the PE GPCI, and updated malpractice premium data (2011 and 2012) as a replacement for 2006 through 2007 data to calculate the MP GPCI. We also note that we do not adjust the medical equipment, supplies and other miscellaneous expe nses component of the PE GPCI because we

continue to believe there is a national market for these items such that there is not a significant geographic variation in costs. However, in light of comments sugge sting that there are geographic differences in shipping costs for medi cal equipment and supplies, we are requesting specific information regarding potential data sour ces for these shipping cost s – especially sources that are publicly available, natio nally representative with suffici ent coverage in both urban and rural areas, and updated at regular intervals. Additionally, we are finalizing our proposal to update the GPCI cost share weights consistent with the revised 2006-based MEI cost share weights finalized in section II.D. of this final rule with comment period. As discussed above in response to comments, use of the revised GPCI co st share weights changed the weighting of the subcomponents within the PE GPCI (employee wages, office rent, purchased services, and medical equipment and supplies). The CY 2014 updated GPCIs and summarized GAFs by Medicare PFS locality may be

found in Addenda D and E to the CY 2014 final ru le available on the CMS website under the

### CMS-1600-FC 511

supporting documents section of the CY 2014 proposed rule web page at http://www.cms.gov/Medicare/Medicare-Fee-for-Ser vice-Payment/PhysicianFeeSched/PFS-FederalRegulation-Notices.html



### . Additional information on the CY 2014 GPCI u pdate may be found in our contractor’s report, “Report on the CY 2014 Upda te of the Geographic Practice Cost Index for the Medicare Physician Fee Schedule, ” which is available on the CMS we bsite. It is located under the supporting documents section of the CY 2014 PFS final rule with comment period located at http://www.cms.gov/Medicare/Medicare-Fee-for-Ser vice-Payment/PhysicianFeeSched/PFS-FederalRegulation-Notices.html



### .

### CMS-1600-FC 512

G. Allowed Expenditures for Physicians' Services and the Sustainable Growth Rate 1. Medicare Sustainable Growth Rate (SGR) The SGR is an annual growth ra te that applies to physicians’ services paid by Medicare. The use of the SGR is intended to control gr owth in aggregate Medi care expenditures for physicians’ services. Payments fo r services are not withheld if the percentage increase in actual expenditures exceeds the SGR. Rather, the PFS upda te, as specified in section 1848(d)(4) of the Act, is adjusted based on a comparison of allo wed expenditures (determined using the SGR) and actual expenditures. If actual expenditures exc eed allowed expenditures, the update is reduced. If actual expenditures are le ss than allowed expenditures, the update is increased. Section 1848(f)(2) of the Act sp ecifies that the SGR for a year (beginning with CY 2001) is equal to the product of the following four factors: (1) The estimated change in fees for physicians' services; (2) The estimated change in the av erage number of Medicare fee-for-service beneficiaries; (3) The estimated projected growth in re al Gross Domestic Product per capita; and (4) The estimated change in expenditures due to changes in st atute or regulations. In general, section 1848(f)(3) of the Act requires us to determine the SGRs for 3 different time periods], using the best data available as of September 1 of each year. Under section 1848(f)(3) of the Act, (beginning with the FY and CY 2000 SGRs) the SGR is estimated and subsequently revised twice based on later data. (The Act also provides for adjustments to be made to the SGRs for FY 1998 and FY 1999. See the February 28, 2003 Federal Register (68 FR 9567) for a discussion of these SGRs). U nder section 1848(f)(3)(C)(i i) of the Act, there

are no further revisions to the SGR once it has be en estimated and subsequently revised in each

### CMS-1600-FC 513

of the 2 years following the preliminary estimate . In this final rule with comment, we are making our preliminary estimate of the CY 2014 SGR, a revision to the CY 2013 SGR, and our

final revision to the CY 2012 SGR. a. Physicians’ Services Section 1848(f)(4)(A) of the Ac t defines the scope of physicians’ services covered by the

SGR. The statute indicates that “the term ‘physicians’ services’ includes other items and services (such as clinical di agnostic laboratory tests and radi ology services), specified by the Secretary, that are commonly perf ormed or furnished by a physicia n or in a physician's office,

but does not include services furnished to a Medicare+Choice plan enrollee.” We published a definition of physicians’ services for use in the SGR in the November 1, 2001 Federal Register (66 FR 55316). We defined physicians’ services to include many of the medical and other health services li sted in section 1861(s) of the Act. Since that time, the statute has been amended to add new Me dicare benefits. As the statute changed, we modified the definition of physicians’ services for the SGR to include the additional benefits

added to the statute that meet the crite ria specified in sec tion 1848(f)(4)(A). As discussed in the CY 2010 PFS final rule with comment period (74 FR 61961), the statute provides the Secretary with clear disc retion to decide whethe r physician-administered drugs should be included or excluded from the definition of “physicians’ services.” Exercising this discretion, we removed physician-administer ed drugs from the definition of physicians’ services in section 1848(f)(4)(A) of the Act for purposes of computing the SGR and the levels of allowed expenditures and actual expenditures beginning with CY 2010, and for all subsequent years. Furthermore, in order to effectuate fu lly the Secretary’s policy decision to remove drugs

### CMS-1600-FC 514

from the definition of physicians’ services, we removed physician-administered drugs from the

calculation of allowed a nd actual expenditures for all prior years. Thus, for purposes of determining allowed expe nditures, actual expend itures for all years, and SGRs beginning with CY 2010 and for all subse quent years, we specified that physicians’

services include the follo wing medical and other health services if bills for the items and services are processed and paid by Medi care carriers (and those paid through intermediaries where specified) or the equivalent services proce ssed by the Medicare Admini strative Contractors:

● Physicians’ services.

● Services and supplies furnished incident to physicians’ serv ices, except for the expenditures for “drugs and biologicals which ar e not usually self-administered by the patient.”

● Outpatient physical therapy services a nd outpatient occupationa l therapy services,

● Services of PAs, certifi ed registered nurse anesthet ists, certified nurse midwives, clinical psychologists, clinical so cial workers, nurse practitioners , and certified nurse specialists.

● Screening tests for prostate cancer, colorectal cancer, and glaucoma.

● Screening mammography, screening pap smears, and screening pelvic exams.

● Diabetes outpatient self-manag ement training (DSMT) services.

● Medical Nutrition Therapy (MNT) services.



### ● Diagnostic x-ray tests, di agnostic laboratory tests, and ot her diagnostic tests (including outpatient diagnostic laboratory test s paid through intermediaries).

● X-ray, radium, and radioactive isotope therapy.

● Surgical dressings, splints , casts, and other devices used for the reduction of fractures

and dislocations.

● Bone mass measurements.

● An initial preventive physical exam.

### CMS-1600-FC 515

● Cardiovascular sc reening blood tests.

● Diabetes screening tests.

● Telehealth services.

● Physician work and resources to establish and document the need for a power mobility

device.

● Additional prev entive services.

● Pulmonary rehabilitation.

● Cardiac rehabilitation.

● Intensive cardiac rehabilitation.

● Kidney disease education (KDE) services.

● Personalized preven tion plan services b. Preliminary Estimate of the SGR for 2014 Our preliminary estimate of the CY 2014 SGR is -16.7 percent. We first estimated the CY 2014 SGR in March 2013, and we made the es timate available to the MedPAC and on our

website. Table 33 shows the March 2013 estimate and our current estimates of the factors included in the 2014 SGR. The majority of th e difference between the March estimate and our

current estimate of the CY 2014 SGR is e xplained by changes in estimated enrollment after our March estimate was prepared. Estimates of 2014 r eal per capita GDP are also higher than were

included in our March 2 013 estimate of the SGR.

### CMS-1600-FC 516

TABLE 33: CY 2014 SGR Calculation Statutory Factors March Estimate Current Estimate Fees 0.5 percent (1.005) 0.6 percent (1.006) Enrollment 4.5 percent (1.045) 2.2 percent (1.022) Real Per Capita GDP 0.6 percent (1.006) 0.8 percent (1.008) Law and Regulation -19.7 percent (0.803) -19.6 percent (0.804) Total -15.2 percent (0.848) -16.7 percent (0.833) Note: Consistent with section 1848(f)(2) of the Ac t, the statutory factors are multiplied, not added, to produce the total (that is, 1.006 x 1.022 x 1.008 x 0. 804 = 0.833). A more de tailed explanation of each figure is provided in section II.G.1.e. of this final rule with comment period.



### c. Revised Sustainable Gr owth Rate for CY 2013

Our current estimate of the CY 2013 SGR is 1.8 percent. Table 34 shows our preliminary estimate of the CY 2013 SGR, which was pub lished in the CY 2013 PFS final rule with comment period, and our current estimate. Th e majority of the di fference between the preliminary estimate and our current estimate of the CY 2013 SGR is explained by adjustments to reflect intervening legisla tive changes that have occurred since publication of the CY 2013 final rule with comment period.

TABLE 34: CY 2013 SGR Calculation Statutory Factors Estimate from CY 2013 Final Rule Current Estimate Fees 0.3 percent (1.003) 0.4 Percent (1.004) Enrollment 3.6 percent (1.036) 1.0 Percent (1.01) Real Per Capita GDP 0.7 percent (1.007) 0.9 Percent (1.009) Law and Regulation -23.3 percent (0.767) -0.5 Percent (0.995) Total -19.7 percent (0.803) 1.8 Percent (1.018) Note: Consistent with section 1848(f)(2) of the Act, th e statutory factors are multiplied, not added, to produce the total (that is, 1.004 x 1.01 x 1.009 x 0.995 = 1.018). A more detailed explanation of each figure is provided in section II.G.1.e. of this final rule with comment period.



### d. Final Sustainable Growth Rate for CY 2012 The SGR for CY 2012 is 5.1 percent. Table 35 shows our preliminary estimate of the CY 2012

SGR from the CY 2012 PFS final rule with comment period, our revised estimate from the CY 2013 PFS

### CMS-1600-FC 517

final rule with comment period, and the final figur es determined using the best available data as of September 1, 2013.



### TABLE 35: CY 2012 SGR Calculation

Statutory Factors Estimate from CY 2012 Final Rule Estimate from CY 2013 Final Rule Final Fees 0.6 percent (1.006) 0.6 percen t (1.006) 0.6 Percent (1.006) Enrollment 3.5 percent (1.035) 

### 1.6 percent (1.016) 0.9 Percent (1.009) Real Per Capita GDP 0.6 percent (1.006) 0.7 percent (1.007) 0.9 Percent (1.009) Law and Regulation -20.7 percent (0.793) 0.0 percent (1.000) 2.6 Percent (1.026) Total -16.9 percent (0.831) 2.3 percent (1.023) 5.1 Percent (1.051) Note: Consistent with section 1848(f)(2) of the Act, th e statutory factors are multiplied, not added, to produce the total (that is, 1.006 x 1.009 x 1.009 x 1.026 = 1.051). A more detailed explanation of each figure is provided in section II.G.1.e. of this final rule with comment period.



### e. Calculation of CYs 2014, 2013, and 2012 SGRs (1) Detail on the CY 2014 SGR All of the figures used to determine the CY 2014 SGR are estimates that will be revised based on subsequent data. Any differences betw een these estimates and the actual measurement of these figures will be included in future re visions of the SGR and allowed expenditures and incorporated into subsequent PFS updates. (a) Factor 1– Changes in Fees for Physic ians’ Services (Before Applying Legislative Adjustments) for CY 2014

This factor is calculated as a weighted average of the CY 2014 changes in fees for the different types of services included in the de finition of physicians’ services for the SGR.

Medical and other health servic es paid using the PFS are estimated to account for approximately 87.7 percent of total allowed ch arges included in the SGR in CY 2014 and are updated using the percent change in the MEI. As discussed in section A of this fi nal rule with comment period, the

### CMS-1600-FC 518

percent change in the MEI for CY 2014 is 0.8 percent. Diagnostic la boratory tests are estimated to represent approximately 12.3 pe rcent of Medicare allowed ch arges included in the SGR for CY 2014. Medicare payments for these tests are updated by the Consumer Price Index for Urban Areas (CPI-U), which is 1.8 per cent for CY 2014. Section 1833(h )(2)(A)(iv) of th e Act requires that the CPI-U update applied to clinical laboratory tests be reduced by a multi-factor productivity adjustment (MFP adjustment) and, for each of years 2011 through 2015, by 1.75 percentage points (percentage adjustment). Th e MFP adjustment will not apply in a year where the CPI-U is zero or a percentage decrease for a year. Further, the application of the MFP adjustment shall not result in an adjustment to the fee schedule of less than zero for a year. However, the application of the percentage adjustment may result in an adjustment to the fee schedule being less than zero for a year and may result in payment rates for a year being less than such payment rates for the preceding year. The applicable productivity adjustment for CY

2014 is -0.8 percent. Adjusting the CPI-U update by the productivity adjust ment results in a 1.0 percent (1.8 percent (CPI-U) minus 0.8 percent (MFP adjustment)) update for CY 2014. Additionally, the percentage re duction of 1.75 percent is app lied for CYs 2011 through 2015, as discussed previously. Therefore, for CY 2014, di agnostic laboratory tests will receive an update of -0.8 percent (rounded). Table 36 shows the wei ghted average of the MEI and laboratory price changes for CY 2014. TABLE 36: Weighted-Average of the ME I and Laboratory Price Changes for CY 2014 Weight Update Physician 0.877 0.8% Laboratory 0.123 -0.8% Weighted-average 1.000 0.6%

### CMS-1600-FC 519

We estimate that the weighted average incr ease in fees for physicians’ services in CY 2014 under the SGR (before applying any legisl ative adjustments) wi ll be 0.6 percent. (b) Factor 2 – Percentage Change in the Av erage Number of Part B Enrollees from CY 2013 to

CY 2014 This factor is our estimate of the percent change in the average number of fee-for-service

enrollees from CY 2013 to CY 2014. Services provided to Medicare Advantage (MA) plan enrollees are outside the scope of the SGR and are excluded from this estimate. We estimate that the average number of Medicare Part B fee-for-service enro llees will increase by 2.2 percent

from CY 2013 to CY 2014. Table 37 illustrates how this figure was determined. TABLE 37: Average Number of Medicare Part B Fee-For-Service Enrollees from CY 2013 to CY 2014 (Excluding Benefici aries Enrolled in MA Plans) CY 2013 CY 2014 Overall 47.982 million 49.459 million Medicare Advantage (MA) 14.837 million 15.569 million Net 33.144 million 33.890 million Percent Increase 1 percent 2.2 percent

An important factor affecting fee-for-service enrollment is beneficiary enrollment in MA plans. Because it is difficult to estimate the size of the MA enrollee population before the start of a CY, at this time we do not know how actual en rollment in MA plans will compare to currentestimates. For this reason, the estimate may change substantially as actual Medicare fee-forservice enrollment for CY 2014 becomes known. (c) Factor 3– Estimated Real Gross Dome stic Product Per Capita Growth in CY 2014 We estimate that the growth in real GDP per capita from CY 2013 to CY 2014 will be 0.8 percent (based on the annual grow th in the 10 year moving aver age of real GDP per capita 2005 through 2014). Our past experience indicates that there have also been changes in estimates of real GDP per capita growth made before the year begins and the actual ch ange in real GDP per

### CMS-1600-FC 520

capita growth computed after the year is comple te. Thus, it is possible that this figure will change as actual information on economic performance becomes available to us in CY 2014. (d) Factor 4 – Percentage Change in Expenditures for Physicians' Services Resulting From Changes in Statute or Regulations in CY 2014 Compared With CY 2013 The statutory and regulatory provisions that will affect expenditures in CY 2014 relative to CY 2013 are estimated to have an impact on expenditures of -19.6 percent. The impact is primarily due to the expiration of the physician f ee schedule update specif ied in statute for CY 2013 only. (2) Detail on the CY 2013 SGR

A more detailed discussion of our revised estim ates of the four elements of the CY 2013

SGR follows. (a) Factor 1 – Changes in Fees for Physic ians' Services (Before Applying Legislative Adjustments) for CY 2013

This factor was calculated as a weighted-average of the CY 2013 changes in fees that apply for the different types of services included in the definition of physicians' services for the

SGR in CY 2013. We estimate that services paid using the PFS account for approximate ly 90.1 percent of total allowed charges included in the SGR in CY 2013. These se rvices were updated using the CY 2013 percent change in the MEI of 0.8 percent. We estimate that diagnostic laboratory tests represent approximately 9.9 percen t of total allowed charges in cluded in the SGR in CY 2013. For CY 2013, diagnostic laborat ory tests received an update of -3.0 percent. Table 38 shows the weighted-average of th e MEI and laboratory price changes for

CY 2013.

### CMS-1600-FC 521

TABLE 38: Weighted-Average of the MEI, and Laboratory Price Changes for CY 2013 Weight Update Physician 0.901 0.8 Laboratory 0.099 -3.0 Weighted-average 1.000 0.4



### After considering the elements describe d in Table 38, we estimate that the weighted-average increase in fees for physic ians' services in CY 2013 under the SGR was 0.4 percent. Our estimate of th is factor in the CY 2013 PFS fina l rule with comment period was 0.3 percent (77 FR 69133). (b) Factor 2 – Percentage Change in the Aver age Number of Part B Enrollees from CY 2012 to

CY 2013 We estimate that the average number of Me dicare Part B fee-for-service enrollees (excluding beneficiaries enrolled in Medicare Advantage plans) increased by 1.0 percent in

CY 2013. Table 39 illustrates how we determined this figure. TABLE 39: Average Number of Medicare Part B Fee-For-Service Enrollees from CY 2012 to CY 2013 (Excluding Beneficiaries Enrolled in MA Plans)

CY 2012 

### CY 2013 Overall 

### 46.405 million 47.982 million Medicare Advantage (MA) 

### 13.586 million 14.837 million Net 

### 32.818 million 33.144 million Percent Increase 0.9 percent 1.0 percent



### Our estimate of the 1.0 percent change in the number of fee-for-service enrollees, net of Medicare Advantage enrollment for CY 2013 co mpared to CY 2012, is different than our original estimate of an incr ease of 3.6 percent in the CY 2013 PFS final rule with comment period (77 FR 69133)

. While our current projection based on data from 8 months of CY 2013 differs from our original estimat e of 0.4 percent when we had no act ual data, it is still possible

### CMS-1600-FC 522

that our final estimate of this figure will be different once we have complete information on

CY 2013 fee-for-service enrollment. (c) Factor 3 –Estimated Real GDP Per Capita Growth in CY 2013 We estimate that the growth in real GDP per capita will be 0.9 percent for CY 2013 (based on the annual growth in the 10-year movi ng average of real GDP per capita (2004 through 2013)). Our past experience indicates that there have also been di fferences between our estimates of real per capita GDP growth made prior to the year's end and the actual change in this factor. Thus, it is possible that this figure will chan ge further as complete actual information on CY 2013 economic performance becomes available to us in CY 2014. (d) Factor 4 – Percentage Change in Expenditures for Physicians' Services Resulting From Changes in Statute or Regulations in CY 2013 Compared With CY 2012 The statutory and regulatory provisions that affected expenditures in CY 2013 relative to CY 2012 are estimated to have an impact on expe nditures of -0.5 percent. This impact is primarily due to the expiration of the PFS update specified in st atute for CY 2013 only. (3) Detail on the CY 2012 SGR

A more detailed discussion of our final revise d estimates of the four elements of the

CY 2012 SGR follows. (a) Factor 1 – Changes in Fees for Physicians' Services for CY 2012 This factor was calculated as a weighted av erage of the CY 2012 changes in fees that apply for the different types of services included in the definition of physicians' services for the

SGR in CY 2012. We estimate that services paid under the PFS account for approximately 90 percent of total allowed charges included in the SGR in CY 2012. These se rvices were updated using the

### CMS-1600-FC 523

CY 2012 percent change in the MEI of 0.6 percent. We estimate that diagnostic laboratory tests represent approximately 10 percen t of total allowed charges in cluded in the SGR in CY 2012. For CY 2012, diagnostic laborat ory tests received an update of 0.7 percent. Table 40 shows the weighted-average of th e MEI and laboratory price changes for

CY 2012. TABLE 40: Weighted-Average of the MEI, Laboratory, and Drug Price Changes for 2012 Weight Update Physician 0.900 0.6 Laboratory 0.100 0.7 Weighted-average 1.00 0.6

After considering the elements describe d in Table 40, we estimate that the weighted-average increase in fees for physicia ns' services in CY 2012 under the SGR (before applying any legislative adjustments) was 0.6 pe rcent. This figure is a final one based on complete data for CY 2012. (b) Factor 2

– Percentage Change in the Average Nu mber of Part B Enrollees from CY 2011 to

CY 2012 We estimate the change in the number of fee-for-service enrollees (excluding

beneficiaries enrolled in MA plans) from CY 2011 to CY 2012 was 0.9 percent. Our calculation of this factor is based on complete data from CY 2012. Table 41 illustra tes the calculation of

this factor.

### CMS-1600-FC 524

TABLE 41: Average Number of Medicare Part B Fee-For-Service Enrollees from CY 2011 to CY 2012 (Excluding Benefici aries Enrolled in MA Plans)

CY 2011 CY 2012 Overall 44.906 46.405 Medicare Advantage (MA) 12.382 13.586 Net 32.524 32.818 Percent Change

.................. 0.9%

(c) Factor 3 – Estimated Real GDP Per Capita Growth in CY 2012 We estimate that the growth in real per capita GDP was 0.9 percent in CY 2012 (based on the annual growth in the 10-y ear moving average of real GDP per capita (2003 through 2012)). This figure is a final one based on complete data for CY 2012. (d) Factor 4 – Percentage Change in Expenditures for Physicians’ Services Resulting From Changes in Statute or Regulations in CY 2012 Compared With CY 2011. Our final estimate for the net impact on e xpenditures from the st atutory and regulatory provisions that affect expenditu res in CY 2012 relative to CY 2011 is 2.6 percent. This is primarily an effect of the statutory requirements surroundi ng the temporary physician fee schedule update in CY 2012. 2. The Update Adjustment Factor (UAF) Section 1848(d) of the Act pr ovides that the PFS update is equal to the product of the MEI and the UAF. The UAF is applied to make act ual and target expenditures (referred to in the statute as “allowed expenditures”) equal. As discussed previously, al lowed expenditures are equal to actual expenditures in a base period upda ted each year by the SGR. The SGR sets the annual rate of growth in allowed expenditures and is determined by a formula specified in section 1848(f) of the Act.

### CMS-1600-FC 525

The calculation of the UAF is not affected by sequestration. Pursuant to 2 U.S.C. 906(d)(6), “The Secretary of Health and Hu man Services shall not take into account any reductions in payment amounts which have been or may be effected under [sequestration], for purposes of computing any adjustments to paym ent rates under such title XVIII”. Therefore, allowed charges, which are unaffected by seque stration, were used to calculate physician expenditures in lieu of Medicare payments plus beneficiary cost-shari ng. As a result, neither actual expenditures or allowed expenditures were adjusted to reflect the impact of sequestration.

a. Calculation under Current Law Under section 1848(d)(4)(B) of the Act, th e UAF for a year beginning with CY 2001 is equal to the sum of the following--

● Prior Year Adjustment Component . An amount determined by— ++ Computing the difference (which may be positive or negative) between the amount of the allowed expenditures for physicians ’ services for the prior year (t he year prior to the year for which the update is being determined) and th e amount of the actual expenditures for those services for that year; ++ Dividing that difference by the amount of the actual expenditures for those services for that year; and ++ Multiplying that quotient by 0.75.

● Cumulative Adjustment Component . An amount determined by— ++ Computing the difference (which may be positive or negative) between the amount of the allowed expenditures for physicians' services from April 1, 1996, through the end of the prior year and the amount of the act ual expenditures for those se rvices during that period;

### CMS-1600-FC 526

++ Dividing that difference by actual expenditu res for those services for the prior year as increased by the SGR for the year for wh ich the UAF is to be determined; and ++ Multiplying that quotient by 0.33. Section 1848(d)(4)(E) of the Act requires the Secretary to recalculate allowed expenditures consistent with se ction 1848(f)(3) of the Act. As discussed previously, section 1848(f)(3) specifies that the SGR (and, in tur n, allowed expenditures) for the upcoming CY (CY 2014 in this case), the current CY (that is, CY 2013) and the preceding CY (that is, CY 2012) are to be determined on the basis of the best data available as of September 1 of the current year. Allowed expenditures for a year ge nerally are estimated initially and subsequently

revised twice. The second revi sion occurs after the CY has e nded (that is, we are making the second revision to CY 2012 allowed expenditures in this final rule with comment).

Table 42 shows the historical SGRs corre sponding to each period through CY 2014.

TABLE 42: Annual and Cumulative Allowed and Actual Expenditures for Physicians' Services from April 1, 1996 through the End of the Upcoming Calendar Year

Period Annual Allowed Expenditures ($ in billions) Annual Actual Expenditures ($ in billions) Cumulative Allowed Expenditures ($ in billions) Cumulative Actual Expenditures ($ in billions) FY/CY SGR

4/1/96-3/31/97 47.0 47.0 47 .0 47.0 ........................ 4/1/97-3/31/98 48.5 47.2 95.6 94.3 3.2 4/1/98-3/31/99 50.6 48.1 146.2 142.4 4.2 1/1/99-3/31/99 12.7 12.5 14 6.2 142.4 ........................ 4/1/99-12/31/99 40.5 37.2 186.7 179.6 6.9 1/1/99-12/31/99 53.2 49.7 18 6.7 179.6 ........................ 1/1/00-12/31/00 57.1 54.4 243.7 234.0 7.3 1/1/01-12/31/01 59.7 61.5 303.4 295.5 4.5 1/1/02-12/31/02 64.6 64.8 368.0 360.3 8.3 1/1/03-12/31/03 69.3 70.4 437.3 430.7 7.3 1/1/04-12/31/04 73.9 78.5 511.2 509.1 6.6 1/1/05-12/31/05 77.0 83.8 588.2 593.0 4.2 1/1/06-12/31/06 78.2 85.1 666.4 678.1 1.5 1/1/07-12/31/07 80.9 85.1 747.2 763.1 3.5 1/1/08-12/31/08 84.5 87.3 831.8 850.4 4.5 1/1/09-12/31/09 89.9 91.1 921.7 941.5 6.4

### CMS-1600-FC 527

Period Annual Allowed Expenditures ($ in billions) Annual Actual Expenditures ($ in billions) Cumulative Allowed Expenditures ($ in billions) Cumulative Actual Expenditures ($ in billions) FY/CY SGR

1/1/10-12/31/10 97.9 96 1,019.60 1,037.40 8.9 1/1/11-12/31/11 102.5 99.6 1,122.20 1,137.10 4.7 1/1/12-12/31/12 107.8 99.5 1,230.00 1,236.60 5.1 1/1/13-12/31/13 109.7 102.2 1,339.70 1,338.80 1.8 1/1/14-12/31/14 91.4 N/A 1,431.10 N/A -16.7 (1) Allowed expenditures in the first year (April 1, 1996-March 31, 1997) are equal to actual expenditu res. All subsequent figure s are equal to quarterly allowed expenditure figures increas ed by the applicable SGR. Cumulative a llowed expenditures are equal to the sum of annual allowed expenditures. We provide more detailed quarterly allowed and actual expenditure data on our we bsite at the following address: http://www.cms.hhs.gov/Sust ainableGRatesConFact/ . We expect to update the website with th e most current information later this month. (2) Allowed expenditures for the first quart er of 1999 are based on the FY 1999 SGR. (3) Allowed expenditures for the last three quarters of 1999 are based on the FY 2000 SGR.



### Consistent with section 1848(d )(4)(E) of the Act, Table 42 includes our second revision of allowed expenditures for CY 2012, a recalculation of allowed expenditures for CY 2013, and our initial estimate of allowed expenditures for CY 2014. To determine the UAF for CY 2014, the statute requires that we use allowed and actual expendit ures from April 1, 1996 through December 31, 2013 and the CY 2014 SGR. Consistent with section 1848(d)(4)(E) of the Act, we will be making revisions to the CY 2013 and CY 2014 SGRs and CY 2013 and CY 2014 allowed expenditures. Because we have incomplete ac tual expenditure data for CY 2013, we are using an estimate for this period. Any difference be tween current estimates and final figures will be taken into account in determining the UAF for future years. We are using figures from Table 42 in the following statutory formula:

33

. 0 75

. 0 13 / 12 96 / 4 13 / 12 96 / 4 14 

### × × − + × −

− −

= 14 13 13 13 13 

### SGR Actual Actual Target Actual Actual Target UAF



### UAF 14 

### = Update Adjustment Factor for CY 2014= 3.0 percent Target 13 

### = Allowed Expenditures for CY 2013= $109.7 billion

Actual 13 

### = Estimated Actual Expenditures for CY 2013 = $102.2 billion

### CMS-1600-FC 528

Target 4/96-12/13 

### = Allowed Expenditures from 4/1/1996 - 12/31/2013 = $1,339.70 billion

Actual 4/96-12/13 

### = Estimated Actual Expenditures fr om 4/1/1996 - 12/31/2013 = $1,338.80 billion

SGR 14 

### = -16.7 percent (0.833)

Section 1848(d)(4)(D) of the Act indicates that the UAF determined under section 1848(d)(4)(B) of the Act for a year may not be less than -0.07 or greater than 0.03. Since 0.059 (5.9 percent) is greater than 0.03, the UAF for CY 2014 will be 3 percent. Section 1848(d)(4)(A)(ii ) of the Act indicates that 1.0 should be added to the UAF determined under section 1848(d)(4)(B) of the Act. Thus, adding 1.0 to 0.03 makes the UAF equal to 1.03. 3. Percentage Change in the MEI for CY 2014 MEI is required by section 1842(b)(3) of the Ac t, which states that prevailing charge levels beginning after June 30, 1973 may not exceed the level from the previous year except to the extent that the Secretary finds, on the basi s of appropriate economic index data, that the higher level is justified by year -to-year economic changes. The current form of the MEI was detailed in the CY 2010 PFS final rule (75 FR 73262), which updated the co st structure of the index from a base year of 2000 to 2006. Additiona l updates to the MEI are discussed in section II.D of this final rule with comment period. The MEI measures the weighted-average annua l price change for various inputs needed to produce physicians' services. The MEI is a fixe d-weight input price inde x, with an adjustment for the change in economy-wide multifactor productivity. This index, which has CY 2006 base % 9

. 5 33

. 0 833

. 2

. 102 $ 80

. 1338 $ 70

. 1339 $ 75

. 0 2

. 102 $ 2

. 102 $ 7

. 109 $

= × × − + × −

### CMS-1600-FC 529

year weights, is comprised of two broad categorie s: (1) physician's own time; and (2) physician's practice expense (PE). The physician's compensation (own time) comp onent represents the net income portion of business receipts and primarily reflects the input of the physician's own time into the production of physicians' services in physicians ' offices. This category consists of two subcomponents: (1) wages and salari es; and (2) fringe benefits. The physician's practice expense (PE) categor y represents nonphysician inputs used in the production of services in physicians' offices. This category consists of wages and salaries and fringe benefits for nonphys ician staff (who cannot bill inde pendently) and other nonlabor inputs. The physician's PE compone nt also includes the following categories of nonlabor inputs: office expenses; medical materials and supplies; professional liability insurance; medical equipment; medical materials and supplies; and other professional expenses. Table 43 lists the MEI cost categories with associated weights and percent changes for price proxies for the CY 2014 update. The CY 2014 final MEI update is 0.8 percent and reflects a 1.9 percent increase in physician’s own time an d a 1.4 percent increase in physician’s PE. Within the physician’s PE, the largest increase occurre d in postage, which increased 4.9 percent. For CY 2014, the increase in the MEI is 0.8 pe rcent, which reflects an increase in the nonproductivity adjusted MEI of 1.7 percent and a pr oductivity adjustment of 0.9 percent (which is based on the 10-year moving average of econom y-wide private nonfarm business multifactor productivity). The BLS is the agency that publis hes the official measure of private non-farm business MFP. Please see http://www.bls.gov/mfp, which is the link to the BLS historical published data on the measure of MFP.

TABLE 43: Increase in the Medicare Economic Index Update for CY 2014 1

### CMS-1600-FC 530

Revised Cost Category 2006 Revised Cost Weight 2 CY14 Update (percent) MEI Total, productivity adjusted 100.000% 0.8 Productivity: 10-year moving average of MFP 1 N/A 5 0.9 MEI Total, without productivity adjustment 100.000% 1.7 Physician Compensation 3 50.866% 1.9 Wages and Salaries 43.641% 1.9 Benefits 7.225% 2.2 Practice Expense 49.134% 1.4 Non-physician compensation 16.553% 1.7 Non-physician wages 11.885% 1.7 Non-health, non-physician wages 7.249% 1.8 Professional & Related 0.800% 1.9 Management 1.529% 1.8 Clerical 4.720% 1.8 Services 0.200% 1.5 Health related, non-physician wages 4.636% 1.4 Non-physician benefits 4.668% 1.9 Other Practice Expense 32.581% 1.2 Utilities 1.266% 0.7 Miscellaneous Office Expenses 2.478% 0.3 Chemicals 0.723% -1.2 Paper 0.656% 1.1 Rubber & Plastics 0.598% 0.5 All other products 0.500% 1.9 Telephone 1.501% 0.0 Postage 0.898% 4.9 All Other Professional Services 8.095% 1.8 Professional, Scien tific, and Tech. Services 2.592% 1.7 Administrative and support & waste 3.052% 1.9 All Other Services 2.451% 1.6 Capital 10.310% 0.7 Fixed 8.957% 0.7 Moveable 1.353% 0.7 Professional Liability Insurance 4 4.295% 1.5 Medical Equipment 1.978% 1.2 Medical supplies 1.760% 1.0 1 The forecasts are based upon the late st available Bureau of Labor Statisti cs data on the 10-year average of BLS private nonfarm business multifactor productivity published on June 28, 2013. ( http://www.bls.gov/news.release/prod3.nr0.htm ) 2 The weights shown for the MEI components are the 2006 base-year weights, which may not sum to subtotals or totals because of rounding. The MEI is a fixed-weight, Laspeyres-type input price index whose category

### CMS-1600-FC 531

weights indicate the distribution of expenditures among the inputs to physi cians' services for CY 2006. To determine the MEI level for a given year, the price pr oxy level for each component is multiplied by its 2006 weight. The sum of these products (weights multiplied by the price index levels) overall cost categories yields the composite MEI level for a given year. The annual percent change in the MEI levels is an estimate of price change over time for a fixed market bask et of inputs to physicians' services. 3 The measures of productivity, average hourly earnings, Employment Cost Indexes, as well as the various Producer and Consumer Price Indexes can be found on the Bureau of Labor Statistics Web site at http://stats.bls.gov

. 4 Derived from a CMS survey of several major commercial insurers. 5 Productivity is factored into the MEI categories as an adjustment; therefore, no explicit weight exists for productivity in the MEI.



### 4. Physician and Anesthesia Fee Schedule Conversion Factors for CY 2014

The CY 2014 PFS CF is $27.2006. The CY 2014 national average anesthesia CF is $17.2283. a. Physician Fee Schedule Update and Conversion Factor (1) CY 2014 PFS Update The formula for calculating the PFS update is set forth in section 1848(d)(4)(A) of the Act. In general, the PFS update is determined by multiplying the CF for the previous year by the percentage increase in the MEI le ss productivity times the UAF, wh ich is calculated as specified under section 1848(d)(4)(B) of the Act. (2) CY 2014 PFS Conversion Factor Generally, the PFS CF for a year is calculat ed in accordance with section 1848(d)(1)(A) of the Act by multiplying the previous year’s CF by the PFS update. We note section 101 of the Medicare Improveme nts and Extension Act, Division B of the Tax Relief and Health Care Act of 2006 (MIEA- TRHCA) provided a 1-y ear increase in the CY 2007 CF and specified that the CF for CY 2008 must be computed as if the 1-year increase had never applied.

### CMS-1600-FC 532

Section 101 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) provided a 6-month increase in the CY 2008 CF, from January 1, 2008, through June 30, 2008, and specified that the CF for the remaining portion of CY 2008 and the CFs for CY 2009 and subsequent years must be computed as if the 6-month increase had never applied.

Section 131 of the MIPPA extended the increas e in the CY 2008 CF that applied during the first half of the year to the entire year, provided for a 1.1 percent increase to the CY 2009 CF, and specified that the CFs for CY 2010 and subs equent years must be computed as if the increases for CYs 2007, 2008, and 2009 had never applied. Section 1011(a) of the DODAA an d section 5 of the TEA specified a zero percent update for CY 2010, effective January 1, 2010 through March 31, 2010. Section 4 of the Continuing Extension Ac t of 2010 (CEA) extended the zero percent update for CY 2010 through May 31, 2010. Subsequently, section 101(a )(2) of the PACMBPRA provide d for a 2.2 percent update to the CF, effective from June 1, 2010 to November 30, 2010. Section 2 of the Physician Payment and Therapy Relief Act of 2010 (Pub. L. No. 111- 286) extended the 2.2 percent th rough the end of CY 2010. Section 101 of the MMEA provided a zero perc ent update for CY 2011, effective January 1, 2011 through December 31, 2011, and specified that the CFs for CY 2012 and subsequent years must be computed as if the increases in previous years had never applied. Section 301 of the Temporary Payroll Ta x Cut Continuation Act of 2011 (TPTCCA) provided a zero percent update effectiv e January 1, 2012 through February 29, 2012, and specified that the CFs for subsequent time periods must be computed as if the increases in previous years had never applied.

### CMS-1600-FC 533

Section 3003 of the Middle Class Tax Relie f and Job Creation Act of 2012 (Job Creation Act) provided a zero percent update effec tive March 1, 2012 through December 31, 2012, and specified that the CFs for subsequent time periods must be computed as if the increases in previous years had never applied.

Section 601 of the American Taxpayer Relief Act (ATRA) of 2012 (Pub. L. 112-240) provided a zero percent update for CY 2013, effective January 1, 2013 through December 31, 2013, and specified that the CFs for subsequent time periods must be computed as if the increases in previous year s had not been applied. Therefore, under current law, the CF that would be in effect in CY 2013 had the prior increases specified above not applied is $25.0070. In addition, when calculating the PFS CF for a year, section 1848(c)(2 )(B)(ii)(II) of the Act requires that increases or decreases in R VUs may not cause the amount of expenditures for the year to differ more than $20 million from what it would have been in the absence of these changes. If this threshold is exceeded, we must make adjustment s to preserve budget neutrality.

We estimate that CY 2014 RVU changes would result in a decrease in Medicare physician expenditures of more than $20 million. Accord ingly, we are increasing the CF by 0.046 percent

to offset this estimated decrease in Medi care physician expenditu res due to the CY 2014 RVU changes. Furthermore, as discussed in section A of this final rule with comment period, we are increasing the CF by 4.72 percent in order to offs et the decrease in Medicare physician payments due to the CY 2014 rescaling of the RVUs so that the proportions of total payments for the work, PE, and malpractice RVUs match the proportion s in the final revised MEI for CY 2014. Accordingly, we calculate the CY 2014 PFS CF to be $27.2006. This final rule with comment period announces a reduction to payment rates for physicians' services in CY 2014 under the

### CMS-1600-FC 534

SGR formula. These payment ra tes are currently scheduled to be reduced under the SGR system on January 1, 2014. The total reduction in th e MPFS conversion factor between CY 2013 and CY 2014 under the SGR system will be 20.1 percent. By law, we are required to make these reductions in accordance with section 1848(d) and (f) of the Act, and these reductions can only be averted by an Act of Congress. While Congr ess has provided temporary relief from these reductions every year since 2003, a long-term solution is critical. We will c ontinue to work with Congress to fix this untenable situation so doc tors and beneficiaries no longer have to worry about the stability and adequacy of payments fr om Medicare under the Physician Fee Schedule.

We illustrate the calculation of the CY 2014 PFS CF in Table 44.

TABLE 44: Calculation of the CY 2014 PFS CF Conversion Factor in effect in CY 2013 $34.0230 CY 2013 Conversion Factor had statutory increases not applied $25.0070

CY 2014 Medicare Economic Index 0.8 percent (1.008) CY 2014 Update Adjustment Factor 3.0 percent (1.03) CY 2014 RVU Budget Neutrality Adjustment 0.046 percent (1.00046) CY 2014 Rescaling to Match MEI Weights Budget Neutrality Adjustment 4.718 percent (1.04718)

CY 2014 Conversion Factor $27.2006 Percent Change from Conversion Factor in effect in CY 2013 to CY 2014 Conversion Factor -20.1%



### We note payment for services under the PFS will be calculated as follows: Payment = [(Work RVU x Work GPCI) + (P E RVU x PE GPCI) + (Malpractice RVU x Malpractice GPCI)] x CF.

b. Anesthesia Conversion Factor

We calculate the anesthesia CF as indicated in Table 45. Anesthesia services do not have RVUs like other PFS services. Therefore, we account for any necessary RVU adjustments

### CMS-1600-FC 535

through an adjustment to the anesthesia CF to si mulate changes to RVUs. More specifically, if there is an adjustment to the work, PE, or malp ractice RVUs, these adjust ments are applied to the respective shares of the anesthesia CF as th ese shares are proxies for the work, PE, and malpractice RVUs for anesthesia services. Info rmation regarding the an esthesia work, PE, and malpractice shares can be found at the following: https://www.cms.gov/center/anesth.asp

. The anesthesia CF in effect in CY 2013 is $ 21.9243. As explained previously, in order

to calculate the CY 2014 PFS CF, the statute requires us to calculate the CFs for all previous years as if the various legisl ative changes to the CFs for t hose years had not occurred. Accordingly, under current law, the anesthesia CF in effect in CY 2013 had statutory increases not applied is $16.1236. The percent change from the anesthesia CF in effect in CY 2013 to the

CF for CY 2014 is –21.4 percent. We illustrate the calculation of the CY 2014 anesthesia CF in

Table 45.

TABLE 45: Calculation of the CY 2014 Anesthesia CF 2013 National Average Anesthesia Conversion Factor in effect in CY 2013 $21.9243

2013 National Anesthesia Conversion Factor had Statutory Increases Not Applied $16.1236 CY 2014 Medicare Economic Index 0.8 (1.008) CY 2014 Update Adjustment Factor 3.0 (1.003) CY 2014 Budget Neutrality Work and Malpractice Adjustment 0.046 (1.00046) CY 2014 Rescaling to Match MEI Weights Budget Neutrality Adjustment 4.718 percent (1.4718)

CY 2014 Anesthesia Fee Sc hedule Practice Expense Adjustment .9823 (.9823)

CY 2014 Anesthesia Conversion Factor $17.2283 Percent Change from 2013 to 2014 -21.4%

### CMS-1600-FC 536

H. Medicare Telehealth Services for the Physician Fee Schedule 1. Billing and Payment for Telehealth Services a. History Prior to January 1, 1999, Medicare coverage for services delivered via a telecommunications system was limited to services that did not require a face-to-face encounter under the traditional model of medical care. Examples of these services included interpretation of an x-ray, electroencephalogram tracing, and cardiac pacemaker analysis. Section 4206 of the BBA provided for coverage of, and payment for, consultation services delivered via a telecommunications system to Medicare beneficiaries residing in rural health professional shortage areas (HPSAs) as defined by the Public Heal th Service Act. Additionally, the BBA required that a Medicare practitioner (telepresenter) be with the patient at the time of a teleconsultation. Further, the BBA specified that payment for a teleconsultation ha d to be shared between the consulting practitioner and the referring practitioner and could not exceed the fee schedule payment that would have been made

to the consultant for the service furnished. The BBA prohibited payment for any telephone line charges or facility fees associated with the teleconsultation. We implemented this provision in the CY 1999 PFS final rule with comment period (63 FR 58814). Effective October 1, 2001, section 223 of th e Medicare, Medicaid and SCHIP Benefits Improvement Protection Act of 2000 (BIPA) (Pub. L. 106-554) added section 1834( m) to the Act, which significantly expanded Medicare telehealth services. Section 1834(m)(4)(F)(i) of the Act defines

Medicare telehealth services to include consultations , office visits, office psychiatry services, and any additional service specified by the Secretary, when de livered via a telecommunications system. We first implemented this provision in the CY 2002 PFS final rule with comment period (66 FR 55246). Section 1834(m)(4)(F)(ii) of the Act required the Secretary to establish a process that provides for annual updates

to the list of Medicare telehealth services. We estab lished this process in the CY 2003 PFS final rule with comment period (67 FR 79988).

### CMS-1600-FC 537

As specified in regulations at §410.78(b), we ge nerally require that a telehealth service be

furnished via an interactive telecommunications system. Under §410.78(a)(3), an interactive telecommunications system is defined as, “multime dia communications equipment that includes, at a minimum, audio and video equipment permitting two- way, real-time interactive communication between the patient and distant site physic ian or practitioner. Telephones, facsimile machines, and electronic mail systems do not meet the definition of an interac tive telecommunications system.” An interactive telecommunications system is generally required as a condition of payment; however, section 1834(m)(1) of the Act allows the use of asynchronous “store-and -forward” technology when the originating site is a

federal telemedicine demonstrati on program in Alaska or Hawaii. As specified in regulations at §410.78(a)(1), store-and-forward means the asynchron ous transmission of medical information from an originating site to be reviewed at a later time by the practitioner at the distant site. Medicare telehealth services may be furnished to an eligible telehealth individual notwithstanding the fact that the practitioner furnishing the telehealth service is not at the same location as the beneficiary. An eligible telehealth individual means an indivi dual enrolled under Part B who receives a telehealth service furnished at an originating site. Under th e BIPA, originating sites were limited under section 1834(m)(3)(C) of the Act to specified medical faciliti es located in specific geographic areas. The initial list of telehealth originating sites included the office of a practitioner, CAH, a rural health clinic (RHC), a federally qualified health center (FQHC) and a hospital (as defined in section 1861(e) of the Act). More recently, section 149 of the Medicare Improveme nts for Patients and Pr oviders Act of 2008 (Pub. L. 110-275) (MIPPA) expanded the list of telehea lth originating sites to include a hospital-based renal dialysis center, a skilled nursing facility (SNF), and a community mental health center (CMHC). To serve as a telehealth originating site, the Act requires th at a site must also be located in an area designated as a rural HPSA, in a county that is not in a MSA, or must be an entity that participates in a federal telemedicine demonstration project that has been approved by (or receives funding from) the Secretary as of December 31, 2000. Finally, section 1834(m) of the Act does not require the eligible telehealth individual to be with a telepresenter at the originating site.

### CMS-1600-FC 538

b. Current Telehealth Billing and Payment Policies As noted previously, Medicare telehealth services can only be furnished to an eligible telehealth beneficiary in a qualifying originating site. An originating site is defined as one of the specified sites where an eligible telehealth individual is located at the time the service is being furnished via a telecommunications system. The originating sites authorized by the statute are as follows:

● Offices of a physician or practitioner;

● Hospitals;

● CAHs;

● RHCs;

● FQHCs;

● Hospital-Based or Critical Access Hospital-Bas ed Renal Dialysis Centers (including Satellites);

● SNFs;

● CMHCs. Currently approved Medicare telehea lth services include the following:

● Initial inpatient consultations;

● Follow-up inpatient consultations;

● Office or other outpatient visits;

● Individual psychotherapy;

● Pharmacologic management;

● Psychiatric diagnostic interview examination;

● End-stage renal disease (ESRD) related services;

● Individual and group medi cal nutrition therapy (MNT);

● Neurobehavioral status exam;

● Individual and group he alth and behavior assessment and intervention (HBAI);

● Subsequent hospital care;

● Subsequent nursing facility care;

### CMS-1600-FC 539

● Individual and group kidney disease education (KDE);

● Individual and group diabetes self-management training (DSMT);

● Smoking cessation services;

● Alcohol and/or substance abuse a nd brief intervention services;

● Screening and behavioral counseling interventi ons in primary care to reduce alcohol misuse;

● Screening for depression in adults;

● Screening for sexually transmitted infections (STI s) and high intensity behavioral counseling (HIBC) to prevent STIs;

● Intensive behavioral therapy for cardiovascular disease; and

● Behavioral counseling for obesity. In general, the practitioner at the distant site may be any of the following, provided that the practitioner is licensed under state law to furnis h the service via a telecommunications system:

● Physician;

● Physician assistant (PA);

● Nurse practitioner (NP);

● Clinical nurse specialist (CNS);

● Nurse-midwife;

● Clinical psychologist;

● Clinical social worker;

● Registered dietitian or nutrition professional. Practitioners furnishing Medicare telehealth servi ces submit claims for telehealth services to the Medicare contractors that process claims for the service area where their distant site is located. Section 1834(m)(2)(A) of the Act requires that a practitioner w ho furnishes a telehealth service to an eligible telehealth individual be paid an amount equal to the amount that the practitioner would have been paid if

the service had been furnished without the use of a te lecommunications system. Distant site practitioners must submit the appropriate HCPCS procedure code for a covered professional telehealth service,

### CMS-1600-FC 540

appended with the –GT (via interactive audio a nd video telecommunications system) or –GQ (via asynchronous telecommunications system) modifier. By reporting the –GT or –GQ modifier with a covered telehealth procedure code, the distant site practitioner certifies that the beneficiary was present at a telehealth originating site when the telehealth ser vice was furnished. The usual Medicare deductible and coinsurance policies apply to the telehealth services reported by distant site practitioners. Section 1834(m)(2)(B) of the Act provides for payment of a facility fee to the originating site. To be paid the originating site facility fee, the provider or supplier where the eligible telehealth individual is located must submit a claim with HCPCS code Q3014 (t elehealth originating site facility fee), and the provider or supplier is paid according to the applicable payment methodology for that facility or location. The usual Medicare deductible and coinsurance polic ies apply to HCPCS code Q3014. By submitting HCPCS code Q3014, the originating site certifies that it is located in either a rural HPSA or non-MSA county or is an entity that participates in a federa l telemedicine demonstration project that has been approved by (or receives funding from) the Secretary as of December 31, 2000 as specified in section 1834(m)(4)(C)(i)(III) of the Act. As previously described, certain professional services that are commonly furnished remotely using telecommunications technology, but that do not re quire the patient to be present in-person with the practitioner when they are furnished, are covered a nd paid in the same way as services delivered without

the use of telecommunications tec hnology when the practitioner is in-person at the medical facility furnishing care to the patient. Such services typically involve circumstances where a practitioner is able to visualize some aspect of the patient’s conditio n without the patient being present and without the interposition of a third person’s judgment. Visuali zation by the practitioner can be possible by means of x-rays, electrocardiogram or electroencephalogram tr acings, tissue samples, etc. For example, the interpretation by a physician of an actual electrocardi ogram or electroencephalogram tracing that has been transmitted via telephone (that is, electronically, rather th an by means of a verbal description) is a covered physician’s service. These remote services are not Medicare telehealth services as defined under section 1834(m) of the Act. Rather, these remote servi ces that utilize telecommunications technology are

### CMS-1600-FC 541

considered physicians’ services in the same way as ser vices that are furnished in-person without the use of telecommunications technology; they are paid under the same conditions as in-person physicians’ services (with no requirements regarding permissible or iginating sites), and should be reported in the same way (that is, without the –GT or –GQ modifier appended). c. Geographic Criteria for Originating Site Eligibility Section 1834(m)(4)(C)(i)(I) – (III) of the Act specifi es three criteria for the location of eligible telehealth originating sites. One of these is for entiti es participating in federal telemedicine demonstration projects as of December 31, 2000, and the other two are geographic. One of the geographic criteria is that the site is located in a county that is not in an MSA and the other is that the site is located in an area that is designated as a rural HPSA under section 332(a)(1)(A) of the Public Health Service Act (PHSA) (42 U.S.C. 254e(a)(1)(A)). Section 332(a)(1)(A) of the PHSA provides for the designation of various types of HPSAs, but does not provide for “rural” HPSAs. In the absence of guidance in the PHSA, CMS has in the past interpreted the term “rural” under section 1834( m)(4)(C)(i)(I) to mean an area that is not located in an MSA. As such, the current geographic criteria for telehealth originating sites limits eligible sites to

those that are not in an MSA. To determine rural designations with more pr ecision for other purposes, HHS and CMS have sometimes used methods that do not rely solely on MSA designations. For example, the Office of Rural Health Policy (ORHP) uses the Rural Urban Commut ing Areas (RUCAs) to determine rural areas within

MSAs. RUCAs are a census tract-based classification sch eme that utilizes the standard Bureau of Census

Urbanized Area and Urban Cluster definitions in co mbination with work commuting information to characterize all of the nation's census tracts regarding their rural and urban status and relationships. They were developed under a collaborative project between ORHP, the U.S. Department of Agriculture's Economic Research Service (ERS), and the WWAMI Ru ral Health Research Center (RHRC). A more comprehensive description is available at the USDA ERS website at: www.ers.usda.gov/dataproducts/rural-urban-commuting-area-c odes/documentation.aspx#.UcsKfZwzZKE . The RUCA classification scheme contains 10 primary and 30 secondary codes. The primary code numbers (1 through

### CMS-1600-FC 542

10) refer to the primary, or single largest, commuting share. Census tracts with RUCA codes of 4 through 10 refer to areas with a primary commuting share outsi de of a metropolitan area. In addition to counties that are not in an MSA, ORHP considers some census tracts in MSA counties to be rural. Specifically, census tracts with RUCA codes 4 through 10 are consid ered to be rural, as well as census tracts with RUCA codes 2 and 3 that are also at least 400 square miles and have a population density of less than 35 people per square mile. We proposed to modify our regulations regarding originating sites to define rural HPSAs as those

located in rural census tracts as de termined by ORHP stating that by defining “rural” to include geographic areas located in rural census tracts within MSAs we would allow for the appropriate inclusion

of additional HPSAs as areas for tele health originating sites. We also noted that by adopting the more precise definition of “rural” for this purpose we w ould expand access to health care services for Medicare

beneficiaries located in rural areas. We also proposed to change our policy so that geographic eligibility for an originating site would be established and maintained on an annual basis, c onsistent with other telehealth payment policies. Absent this proposed change, the status of a geographi c area’s eligibility for telehealth originating site payment is effective at the same time as the effectiv e date for changes in designations that are made outside of CMS. This proposed change would reduc e the likelihood that mid-year changes to geographic designations would result in sudden disruptions to be neficiaries’ access to ser vices, unexpected changes in eligibility for established telehealth originating s ites, and avoid the operational difficulties associated with administering mid-year Medicare telehealth pa yment changes. We proposed to establish geographic eligibility for Medicare telehealth originating sites fo r each calendar year based upon the status of the area as of December 31st of the prior calendar year. Accordingly, we proposed to revise our regulati ons at §410.78(b)(4) to conform with both of these proposed policies. The following is a summary of the comments we re ceived regarding our proposed changes regarding geographic eligibility for serving as a Medicare telehealth originating site.

### CMS-1600-FC 543

Comment : Commenters supported our proposal to modi fy the geographic criteria for originating site eligibility to define rural HPSAs as those located in rural census tracts, as determined by ORHP. In addition, commenters supported our proposal to est ablish and maintain geographic eligibility on an

annual basis. Commenters noted that these modifications will:

● Expand access to health care services for Medi care beneficiaries by allowing some rural areas within MSAs to be eligible for Medicare telehealth services.

● Provide greater clarity and consiste ncy for those involved in telehealth.

● Allow for better continuity of care in ru ral areas by avoiding sudden disruptions to

beneficiaries’ access to telehealth services.

● Restore eligibility for some counties that we re affected by the updated MSAs based on the

2010 census. Response : We appreciate the broad support for revising the geographic criteria for originating site eligibility and for establishing and maintaining ge ographic eligibility for an originating site on an annual basis. We are finalizing our CY 2014 proposals (1) to define rural HPSAs as those located in rural census tracts as determined by ORHP, and (2) to est ablish and maintain geographic eligibility for an originating site on an annual basis. Consistent with these proposals, we are also revising our regulations at §410.78(b)(4) to conform to these policies.

Comment : Commenters expressed concern that our pr oposed definition of a rural HPSA does not

conform to the definition of a rural HPSA used for ru ral health clinic qualification, that is, a federally designated shortage area or a non-urbanized area, as de fined by the U.S. Census Bureau. As a result, existing RHCs may be excluded from providing telehea lth services to Medicare beneficiaries. To avoid this discrepancy, the commenters re quested further expansion of the geographic criteria for originating site eligibility to include both non-urbanized areas, as defined by the U.S. Census Bureau, and those rural HPSAs located in rural census tracts, as determin ed by ORHP. A commenter also recommended that

CMS work with the Health Resources and Services Ad ministration (HRSA) to update all data with 2010

census information.

### CMS-1600-FC 544

Other commenters recommended expansion of the ge ographic criteria for originating site to urban and suburban areas. A commenter recommended including sites that are located in (1) areas other than rural HPSAs and (2) counties that are included in MSAs . The commenter noted that beneficiaries in both urban and rural areas face significant barriers in accessing care, including access to certain specialists, such as gerontologists, and access to transportation.

A commenter noted that urban and suburban areas do not have appropriate access to acute stroke care, noting that 77 percent of U.S. counties did not have a hospital with neurological services. As a result of these and other barriers, only a small fracti on of patients receive the treatment recommended by the latest scientific guidelines for acute stroke. The commenter concluded that our policy of limiting payment for telehealth services to those originatin g in rural areas has hampered the development of sufficient stroke consultation coverage and recommend el iminating the rural originating site requirement. Another commenter made similar points concerning ca ncer patients living in small urban areas without access to complex subspecialty care. A commenter proposed using RUCAs to determine eligible originating sites, to ensure greater access to telemedicine services. Response : Telehealth originating sites are defined in section 1834(m)(4)(C) of the Act. Only a site that meets one of these requirements can qualify as an originating site: (1) Located in an area that is designated as a ru ral health professional shortage area under section 332(a)(1)(A) of the Public Health Se rvice Act (42 U.S.C. 254e(a)(1)(A)); (2) Located in a county that is not includ ed in a Metropolitan Statistical Area; or (3) From an entity that participates in a Federal telemedicine demonstration project that has been approved by (or receives funding from) the Secretary of Health and Human Services as of December 31,

2000. Although RHCs are among the types of locations that are statutorily authorized to serve as originating sites for telehealth services, they also mu st meet the geographic requirements specified in the statute in order to serve as a telehealth originating s ite. While most RHCs would meet at least one of the geographic requirements to serve as a telehealth orig inating site, the separate statutory provisions that

### CMS-1600-FC 545

establish geographic requirements for telehealth origin ating sites and for RHCs are sufficiently different that they do not necessarily overlap. We do not have the authority to waive the geographic telehealth requirements for those RHCs that do not meet any of the requirements to serve as an originating site. Accordingly, we are not modifying our proposal to expand the scope of telehealth originating sites to include all RHCs, and we are finalizing our proposed regulation without change. We agree with

the commenter that the data that are used to determ ine which areas are rural should be updated to reflect

the 2010 census information.

Comment : Several commenters expressed that the complexity involved in determining geographic eligibility to serve as an originating site to provide telehealth ser vices may deter providers from offering telehealth services. Commenters indicat ed that due to recent ch anges in the 2010 census there have been numerous changes in all rural desi gnations. Commenters noted that RUCAs are a census tract-based classification scheme and there is no single source to determine one’s census tract. Commenters recommended that CMS provide an online tool to allow beneficiaries and providers to determine what specific geographic areas are eligible as telehealth originating sites. One commenter suggested simplifying the process in future years by considering using postal ZIP codes or ZIP+4. Response : We share the commenters’ concern that expanding the geographic definition of “rural” to include more telehealth originating s ites has increased the complexity in determining the eligibility of a particular location to serve as an origin ating site. We are working with HRSA to develop a website tool to provide assistance to potential origin ating sites to determine their eligibility. As it becomes available, we will post further in formation about this on the CMS website at www.cms.gov/teleheath/

. Comment : A commenter expressed concern about the annual changes in coverage within census tracts that may occur under the proposal. The comme nter recommended that CMS use its authority under the statute to avoid annual on/off/on/off coverage to re duce constant fluctuations in coverage of telehealth

services. The commenter concluded that once covere d for telehealth services, a beneficiary should not lose coverage because of accidental circumstances of geographic location and administrative designation.

### CMS-1600-FC 546

Response : This regulation addresses which providers can qualify to be an originating site to

furnish telehealth services. Beneficiaries do not have to meet specialized criteria for telehealth services.

Beneficiaries who are covered under Medicare Part B can receive services on the list of Medicare telehealth services from providers that meet the criteria to serve as an originating site (and other criteria to furnish telehealth services). We recognize that bene ficiaries may experience disruptions in service or challenges in accessing services when a provi der that has been an originating s ite is not eligible in a future year. As discussed above, we believe our proposed po licy mitigates the disruptions caused by mid-year changes in geographic status and expands the scope of providers eligible to serve as telehealth originating sites. However, as noted above, we believe it is n ecessary to use updated inform ation regarding whether a site meets the statutory criteria for originating site e ligibility. We do not believe we have authority to continue treating a site as a telehealth originating site if it ceases to meet the statutory criteria. Thus, we are finalizing the regulations regarding originating sites, as proposed to define rural HPSAs as those

located in rural census tracts as de termined by ORHP and to establish and maintain geographic eligibility for an originating site on an annual basis. 2. Adding Services to the List of Medicare Telehealth Services As noted previously, in the December 31, 2002 Federal Register (67 FR 79988), we established a process for adding services to or deleting services from the list of Medicare telehealth services. This process provides the public with an ongoing opport unity to submit requests for adding services. We assign any request to make additions to the list of tele health services to one of two categories. In the November 28, 2011 Federal Register (76 FR 73102), we finalized revisions to criteria that we use to review requests in the second category. The two categories are:

● Category 1 : Services that are similar to profession al consultations, office visits, and office psychiatry services that are currently on the list of te lehealth services. In reviewing these requests, we look for similarities between the requested and ex isting telehealth services for the roles of, and interactions among, the beneficiary, the physician (or other practitioner) at the distant site and, if

### CMS-1600-FC 547

necessary, the telepresenter. We also look for sim ilarities in the telecommunications system used to deliver the proposed service; for example, the u se of interactive audio and video equipment.

● Category 2 : Services that are not similar to the curren t list of telehealth services. Our review of these requests includes an assessment of whet her the service is accurately described by the corresponding code when delivered via telehealth and whether the use of a telecommunications system to deliver the service produces demonstrated clinical benef it to the patient. In reviewing these requests, we look for evidence indicating that the use of a telecommunications system in delivering the candidate telehealth service produces clinical benefit to th e patient. Submitted evidence should include both a description of relevant clinical studies that demonstr ate the service furnished by telehealth to a Medicare beneficiary improves the diagnosis or treatment of an illness or injury or improves the functioning of a malformed body part, including dates and findings, and a list and copies of published peer reviewed

articles relevant to the service when furnished via teleh ealth. Our evidentiary standard of clinical benefit

does not include minor or incidental benefits. Some examples of clinical benefit include the following:

● Ability to diagnose a medical condition in a patient population without access to clinically appropriate in-person diagnostic services.

● Treatment option for a patient population withou t access to clinically appropriate in-person treatment options.

● Reduced rate of complications.

● Decreased rate of subsequent diagnostic or therapeutic interventions (for example, due to reduced rate of recurrence of the disease process).

● Decreased number of future hosp italizations or physician visits.

● More rapid beneficial resolution of the disease process treatment.

● Decreased pain, bleeding, or other quantifiable symptom.

● Reduced recovery time.

### CMS-1600-FC 548

Since establishing the process to add or remove services from the list of approved telehealth services, we have added the following to the list of Medicare telehealth services: individual and group HBAI services; psychiatric diagnostic interview examination; ESRD services with 2 to 3 visits per month and 4 or more visits per month (altho ugh we require at least 1 visit a month to be furnished in-person by a physician, CNS, NP, or PA to examine the v ascular access site); individual and group MNT; neurobehavioral status exam; initial and follow-up inpatie nt telehealth consultations for beneficiaries in hospitals and SNFs; subseque nt hospital care (with the limitation of one telehealth visit every 3 days); subsequent nursing facility care (with the limitation of one telehealth visit ever y 30 days); individual and group KDE; and individual and group DSMT (with a mi nimum of 1 hour of in-person instruction to ensure effective injection training), smoking cessation services; alcohol and/or substance abuse and brief intervention services; screening and behavioral counse ling interventions in primary care to reduce alcohol misuse; screening for depression in adults; screening for sexually transm itted infections (STIs) and high intensity behavioral counseling (HI BC) to prevent STIs; intensive be havioral therapy for cardiovascular disease; and behavioral counseling for obesity. Requests to add services to the list of Medicare telehealth services must be submitted and received no later than December 31 of each calendar year to be considered for the next rulemaking cycle. For example, requests submitted before the end of CY 2013 will be considered for the CY 2015 proposed rule. Each request for adding a service to the list of Medicare telehealth services must include any supporting documentation the requester wishes us to cons ider as we review the request. Because we use the annual PFS rulemaking process as a vehicle for ma king changes to the list of Medicare telehealth services, requestors should be advised that any inform ation submitted is subject to public disclosure for this purpose. For more information on submitting a request for an addition to the list of Medicare telehealth services, including where to mail these requ ests, we refer readers to the CMS website at www.cms.gov/telehealth/

. 3. Submitted Requests and Other Additions to the List of Telehealth Services for CY 2014

### CMS-1600-FC 549

We received a request in CY 2012 to add online assessment and E/M services as Medicare

telehealth services effective for CY 2014. The foll owing presents a discussion of this request, and our proposals for additions to the CY 2014 telehealth list. a. Submitted Requests The American Telemedicine Association (ATA ) submitted a request to add CPT codes 98969 (Online assessment and management service provided by a qualified nonphysician health care professional to an established patient, guardian, or health care provider not originating from a related assessment and management service provided within the previous 7 days, using the Internet or similar electronic communications network) and 99444 (Onlin e evaluation and management service provided by a physician to an established patient, guardian, or h ealth care provider not originating from a related E/M service provided within the previous 7 days, using the Internet or similar electronic communications network) to the list of Medicare telehealth services. As we explained in the CY 2008 PFS final rule with comment period (72 FR 66371), we assigneda status indicator of ‘‘N’’ (Non-covered service) to these services because: (1) these services are nonface-to-face; and (2) the code descr iptor includes language that recognizes the provision of services to parties other than the beneficiary and for whom Me dicare does not provide coverage (for example, a guardian). Under section 1834(m)(2)(A) of the Act, Medicare pays the physician or practitioner furnishing a telehealth service an amount equal to th e amount that would have been paid if the service was furnished without the use of a telecommunications system. Because CPT codes 98969 and 99444 are currently noncovered, there would be no Medicare pa yment if these services were furnished without the use of a telecommunications system. Since these codes are noncovered services for which no payment may be made under Medicare, we did not propose to add online evaluation and management services to

the list of Medicare Telehealth Services for CY 2014.

b. Other Additions Under our existing policy, we add services to th e telehealth list on a category 1 basis when we determine that they are similar to services on the exis ting telehealth list with respect to the roles of, and

### CMS-1600-FC 550

interactions among, the beneficiary, physician (or othe r practitioner) at the distant site and, if necessary, the telepresenter. As we stated in the CY 2012 propo sed rule (76 FR 42826), we believe that the category 1 criteria not only streamline our review process for publically requested services that fall into this category, the criteria also expedite our ability to identi fy codes for the telehealth list that resemble those services already on this list. For CY 2013, CMS finalized a payment polic y for new CPT code 99495 (Transitional care management services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver within 2 business days of discharge medical decision making of at least moderate complexity during the service period face-to-face visit, within 14 calendar days of discharge) and CPT code 99496 (Transitional care management services with the following required elements: Communication (direct contact, telephone, elect ronic) with the patient and/or caregiver within 2 business days of discharge medical decision making of high complexity during the service period faceto-face visit, within 7 calendar days of discharge). These services are for a patient whose medical and/or psychosocial problems require moderate or high co mplexity medical decision making during transitions in care from an inpatient hospital setting (including acu te hospital, rehabilitation hospital, long-term acute care hospital), partial hospitalization, observation stat us in a hospital, or skilled nursing facility/nursing facility, to the patient’s community setting (home, domiciliary, rest home, or assisted living). Transitional care management is comprised of one face-to-face vi sit within the specified time frames following a discharge, in combination with non-face-to-face services th at may be performed by the physician or other qualified health care professional and/or licensed clinical staff under his or her direction.

We believe that the interactions between the fu rnishing practitioner and the beneficiary described by the required face-to-face visit component of th e transitional care management (TCM) services are sufficiently similar to services currently on the list of Medicare telehealth services for these services to be added under category 1. Specifically, we believe th at the required face-to-face visit component of TCM services is similar to the office/outpatient evaluati on and management visits described by CPT codes

99201-99205 and 99211-9 9215. We note that like certain other non-face-to-face PFS services, the other

### CMS-1600-FC 551

components of the TCM service are commonly furnished remotely using telecommunications technology, and do not require the patient to be present in-person with the practitioner when they are furnished. As such, we do not need to consider whether the non -face-to-face aspects of the TCM service are similar to other telehealth services. Were these components of the TCM services separately billable, they would not

need to be on the telehealth list to be covered a nd paid in the same way as services delivered without the use of telecommunications technology. Therefor e, we proposed to add CPT codes 99495 and 99496 to the list of telehealth services for CY 2014 on a category 1 basis. Consistent with this proposal, we revised our regulations at §410.78(b) and §414.65(a)(1) to include TCM services as Medicare telehealth services. 4. Telehealth Frequency Limitations

The ATA asked that we remove the telehealth frequency limitation for subsequent nursing facility services reported by CPT codes 99307 through 99310. Subsequent nursing facility services were added

to the list of Medicare telehealth services in th e CY 2011 PFS final rule ( 75 FR 73317 through 73318), with a limitation of one telehealth subsequent nurs ing facility care service every 30 days. In the CY 2011 PFS final rule (75 FR 73615) we noted that, as specified in our regulation at §410 .78(e)(2), the federally mandated periodic SNF visits required under §483.40(c) could not be furnished through telehealth. The ATA requested that the frequency lim itation be removed due to “recent federal telecommunications policy changes” and newly availabl e information from recent studies. Specifically, the ATA pointed to the Federal Communications Commission (FCC) pilot funding of a program to

facilitate the creation of a nationw ide broadband network dedicated to health care, connecting public and private non-profit health care providers in rural and urban locations, and a series of studies that demonstrated the value to patients of telehealth technology. In considering this request, we began with th e analysis contained in the CY 2011 proposed rule (75 FR 73318), when we proposed to add SNF subsequent care, to the list of Medicare telehealth services. We discussed our complementary commitments to en suring that SNF residents, given their potential clinical acuity, continue to receive in-person visits as appropriate to manage their complex care and to make sure that Medicare pays only for medica lly reasonable and necessary care. To meet these

### CMS-1600-FC 552

commitments, we believed it was appropriate to limit the provision of subsequent nursing facility care services furnished through telehealth to once every 30 days. We then reviewed the publicly available inform ation regarding both the FCC pilot program and the ATA-referenced studies in light of the prev iously stated commitments to assess whether these developments warrant a change in 30-day frequency li mitation policy. Based on our review of the FCC demonstration project and the studies referenced in the request, we found no information regarding the relative clinical benefits of SNF subsequent care when furnished via telehealth more frequently than once every 30 days. We did note that the FCC informa tion reflected an aim to improve access to medical specialists in urban areas for rural health care provide rs, and that medical specialists in urban areas can continue to use the inpatient telehealth consultati on HCPCS G-codes (specifically G0406, G0407, G0408, G0425, G0426, or G0427) when re porting medically reasonable and n ecessary consultations furnished to

SNF residents via telehealth wit hout any frequency limitation. We also reviewed the studies referenced by the ATA to assess whether they provided evidence that more frequent telehealth vi sits would appropriately serve th is particular population given the potential medical acuity and complexity of patient needs. We did not find an y such evidence in the studies. Three of the studies identified by the ATA we re not directly relevant to SNF subsequent care services. One of these focused on using telehealth te chnology to treat patients with pressure ulcers after spinal cord injuries. The second focused on the useful ness of telehealth technology for patients receiving home health care services. A third study addressed the use of interactive communication technology to facilitate the coordination of care between hospital an d SNF personnel on the day of hospital discharge. The ATA also mentioned a peer-reviewed presentation delivered at its annual meeting related to SNF patient care, suggesting that the presentation demonstrated that telehealth visits are better for SNF patients than in-person visits to emergency departments or, in some cases, visits to physician offices. Although we did not have access to the full presentation it does not appear to address subsequent nursing facility services, so we do not believe this is directly relevant to the clinical benefit of SNF subsequent care furnished via telehealth. More importantly, no ne of these studies addresses the concerns we have

### CMS-1600-FC 553

expressed about the possibility that nursing facility subsequent care visits furnished too frequently through telehealth rather than in -person could compromise care for this potentially acute and complex patient population. We remain committed to ensuring that SNF inpatie nts receive appropriate in-person visits and that Medicare pays only for medically reasonable a nd necessary care. We are not persuaded by the information submitted by the ATA that it would be be neficial or advisable to remove the frequency limitation we established for SNF subsequent care when furnished via telehealth. Because we want to ensure that nursing facility patients with complex medical conditions have appropriately frequent, medically reasonable and necessary encounters with th eir admitting practitioner, we continue to believe that it is appropriate for some sub sequent nursing facility care services to be furnished through telehealth. At the same time, because of the potential acuity an d complexity of SNF inpatients, we remain committed to ensuring that these patients continue to receive in -person, hands-on visits as appropriate to manage their care. Therefore, we did not propose any chan ges to the limitations regarding SNF subsequent care

services furnished via telehealth for CY 2014. The following is summary of the comments we received regarding adding services to the list of

Medicare telehealth services.

Comment : All commenters expressed support for our proposals to add transitional care management (CPT codes 99495 and 994 96) to the list of Medicare telehealth services for CY 2014. A commenter suggested that CMS allow the required E/ M visit component of the two CPT codes to be

delivered via telehealth. Response : We appreciate the support for the proposed a dditions to the list of Medicare telehealth services. In response to the commenter asking that the required E/M visit comp onent be allowed to be furnished via telehealth, adding TCM CPT codes 994 95 and 99496 to the list of Medicare telehealth services allows the E/M portion of these services to be fu rnished via telehealth. Af ter consideration of the public comments received, we are finalizing our CY 2014 proposal to add TCM CPT codes 99495 and 99496 to the list of telehealth services for CY 2014 on a category 1 basis.

### CMS-1600-FC 554

Comment : Another commenter recommended that the originating site be required to conduct a physical examination of a patient’s mental and physical condition following a care transaction, and

transmit the results to the consultin g physician before or during the te lehealth session, as a condition for coverage of transitional care manageme nt services provided via telehealth. Response : Concerning the conduct of a physical examination, nothing would preclude such an in person, face-to-face examination from occurring at th e originating site; and the TCM codes describe communication between practitioners, when appropriate. We are not adopting this recommendation as

we do not believe there is a reason to treat these new a dditions to the list of telehealth services differently than services already on the list.

Comment : A commenter asked whether providing tran sitional care management via telehealth applies to services furnished in privat e homes and assisted living facilities. Response : No, in furnishing TCM services as tele health services, all other conditions for telehealth services still apply. In addition to geogra phic criteria, the statutory criteria for eligible originating sites include only certain types of loca tions specified in section 1834(m)(4)(C)(ii) of the Act, and those do not include private homes and assisted living facilities.

Comment : A commenter supported our decision not to remove the telehealth frequency limitation for subsequent nursing facility services reported by CPT codes 99307 through 99310. The commenter noted that telehealth occupational ther apy services are just beginni ng to be provided and evaluated, and indicated that it is important to ensu re that care for the acute and complex patients found in SNFs is not compromised, regardless of the mode used to provide services. Another commenter disagreed with our determina tion that there is no relative clinical benefit from allowing SNF services to be provided via telehea lth more than once every 30 days. The commenter indicated that CMS recently issued Survey and Certification Memo 13-35-NH, which put additional emphasis on the survey process for managing behavior al or psychological symptoms of dementia and limiting the use of antipsychotic medications in SN Fs. The commenter concluded that having this medical/behavioral evaluation performed by the primar y care provider or a psychiatrist using telehealth

### CMS-1600-FC 555

could help reduce the need to transfer the patient to the emergency department, which could possibly exacerbate dementia symptoms. A commenter stated that the frequency limitation can result in additional unnecessary transports for office or emergency department visits, additi onal opportunities for patient injury, and significant transportation costs especially for the immobile and di sabled patient. In light of the evolving mobile health technologies, robotics, and miniaturization of telecommunications tools and medical devices, as well as the increasing complexity and co-morbidities of SNF patients, the commenter recommended setting the limit at one visit per 10 days. A commenter suggested that subsequent nursi ng facility care services furnished through

telehealth should not be limited to one service ever y 30 days, as long as the federally mandated SNF visits are conducted on an in-person basis. Response : We appreciate the comment in support of maintaining the 30-day limit. Commenters opposed to the 30-day limit offered no clinically pers uasive evidence to support their positions. Survey and Certification Memo 13-35-NH addresses dementia care in nursing homes and unnecessary drug use. The memo does not address telehealth services, a nd does not represent clinical evidence supporting removal of the telehealth frequency limitation for subs equent nursing facility services. Therefore, we are maintaining the 30-day frequency limitation for subseque nt nursing facility services due to the absence of evidence regarding the relative clinical benefits of SNF subsequent care when furnished via telehealth more frequently than once every 30 days, and to ensure that SNF patients continue to receive in-person, hands-on visits as appropriate to manage their care.

Comment : A commenter urged CMS to reconsider its decision to not include CPT codes 98969 (Online assessment and management service provided by a qualified nonphysician health care professional to an established patient, guardian, or health care provider not originating from a related assessment and management service provided within the previous 7 days, using the Internet or similar electronic communications network) and 99444 (Onlin e evaluation and management service provided by a physician to an established patient, guardian, or h ealth care provider not originating from a related E/M

### CMS-1600-FC 556

service provided within the previous 7 days, using the Internet or similar electronic communications network) on the list of Medicare telehealth services. The commenter noted that such services can serve as a valuable preventive benefit in the treatment and car e of Medicare beneficiaries; that such services are

often are unavailable to beneficiaries who reside in ve ry rural areas; and that telehealth services should be expanded in view of the increasing number of bene ficiaries and the projected physician shortage. Response : As noted previously, we did not propose to add the subject codes to the list of telehealth services because they are noncovered services for which no payment may be made under Medicare. Accordingly we are finalizing our proposal. In summary, after consideration of the comments we received we are finalizing the changes to our regulation at §410.78 to add “trans itional care management” to the list of services in paragraph (b) as proposed.

We remind all interested stakeholders that we are currently soliciting public requests to add

services to the list of Medicare telehealth services. To be considered durin g PFS rulemaking for CY 2015, these requests must be submitted and received by December 31, 2013, or the close of the comment period for this final rule with comment period. E ach request to add a service to the list of Medicare telehealth services must include any supporting documen tation the requester wishes us to consider as we review the request. For more information on submitti ng a request for an addition to the list of Medicare telehealth services, including where to mail these requ ests, we refer readers to the CMS website at www.cms.gov/telehealth/

. 5. Telehealth Originating Site Facility Fee Payment Amount Update Section 1834(m)(2)(B) of the Act establishes th e payment amount for the Medicare telehealth originating site facility fee for telehealth services provided from October 1, 2001, through December 31 2002, at $20.00. For telehealth service s provided on or after Janua ry 1 of each subsequent calendar year, the telehealth originating site facility f ee is increased by the perc entage increase in the MEI as defined in section 1842(i)(3) of the Act. The MEI increase for 2014 is 0.8 percent. Therefore, for CY 2014, the payment amount for HCPCS code Q3014 (T elehealth originating site facility fee) is

### CMS-1600-FC 557

80 percent of the lesser of the actual charge or $24.63 . The Medicare telehealth originating site facility fee and MEI increase by the applicable time period is shown in Table 46. TABLE 46: The Medicare Telehealth Originat ing Site Facility Fee and MEI Increase by the Applicable Time Period Facility Fee MEI Increase Period

$20.00 N/A 10/01/2001 – 12/31/2002 $20.60 3.0% 01/01/2003 – 12/31/2003 $21.20 2.9% 01/01/2004 – 12/31/2004 $21.86 3.1% 01/01/2005 – 12/31/2005 $22.47 2.8% 01/01/2006 – 12/31/2006 $22.94 2.1% 01/01/2007 – 12/31/2007 $23.35 1.8% 01/01/2008 – 12/31/2008 $23.72 1.6% 01/01/2009 – 12/31/2009 $24.00 1.2% 01/01/2010 – 12/31/2010 $24.10 0.4% 01/01/2011 – 12/31/2011 $24.24 0.6% 01/01/2012 – 12/31/2012 $24.43 0.8% 01/01/2013 – 12/31/2013 $24.63 0.8% 01/01/2014 – 12/31/2014

### CMS-1600-FC 558

I. Therapy Caps 1. Outpatient Therapy Caps for CY 2014 Section 1833(g) of the Act applies annual, per beneficiary, limitations on expenses that can be considered as incurred expenses for outpatient therapy services under Medicare Part B, commonly referred to as “therapy caps.” There is one therapy cap for outpatient occupational therapy (OT) services and another separate therapy cap for physical ther apy (PT) and speech-language pathology (SLP) services

combined. Until October 1, 2012, the therapy caps applied to all outpatient therapy services except those under section 1833(a)(8)(B) of the Act, which describes services furnished by a hospital or another entity under an arrangement with a hospital. For convenien ce, we will refer to the exemption from the caps for services described under section 1833(a)(8)(B) of the Ac t as the “outpatient hospital services exemption.” Section 3005(b) of the MCTRJCA added section 1833(g)(6) of the Act to temporarily suspend the outpatient hospital services exemption, thereby requir ing that the therapy caps apply to services described under section 1833(a)(8)(B) of the Act from October 1, 2012 to December 31, 2012 for services furnished beginning January 1, 2012. This broadened app lication of the therapy caps was extended through December 31, 2013, by section 603(a) of the ATRA. In addition, section 603( b) of the ATRA amended section 1833(g)(6) of the Act to specify that during CY 2013, for outpatient therapy services paid under section 1834(g) of the Act (those furnished by a CAH), we must count towards the therapy caps the amount that would be payable for the services under Medicare Part B if the services were paid as outpatient therapy services under section 1834(k)(1)(B) of the Act, which describes payment for outpatient therapy services furnished by hospitals and certain other entities, instead of as CAH outpatient therapy services under section 1834(g) of the Act. Payment for outpatient therapy services under section 1834(k)(1)(B) of the Act is made at 80 percent of the lesser of the actual charge for the services or the applicable fee schedule amount as defined in section 1834( k)(3) of the Act. Section 1834(k)(3) of the Act defines applicable fee schedule to mean the paym ent amount determined under a fee schedule established under section 1848 of the Act, which refers to the PFS, or an amount under a fee schedule for comparable

### CMS-1600-FC 559

services as the Secretary specifies. The PFS is the appli cable fee schedule to be used as the payment basis under section 1834(k)(3) of the Act. Section 603( b) of the ATRA specified that nothing in the amendments to section 1833(g)(6) of the Act “shall be construed as changing the method of payment for outpatient therapy services under 1834(g) of the Act.” Since CY 2011, a therapy multiple procedure pa yment reduction (MPPR) policy has applied to the second and subsequent “always therapy” services bille d on the same date of service for one patient by the same practitioner or facility under the same NPI. Prior to April 1, 2013, the therapy MPPR reduced the practice expense portion of office-based service s by 20 percent and reduced the practice expense portion of institutional-based services by 25 percent. As of April 1, 2013, section 633(a) of the ATRA amended sections 1848(b)(7) and 1 834(k) of the Act to increase the therapy MPPR to 50 percent for all outpatient therapy services furnished in office-based a nd institutional settings. (For more information on the MPPR and its history, see section II.C.4 of this final rule with comment period.) Section 1833(g) of the Act applies the therapy caps to incurred expenses for outpatient therapy services on a calendar year basis, and section 603(b) of the ATRA requires that we accrue toward the therapy caps a proxy value for a beneficiary’s incu rred expenses for outpatient therapy services furnished by a CAH during CY 2013. Since payment for outpatient therapy services under section 1834(k)(1)(B) of the Act is made at the PFS rate and includes any applicable therapy MPPR, the proxy amounts accrued toward the caps for therapy services furnished by a CAH also reflect any applicable therapy MPPR.

We believe that this is consis tent with the statutory amendments made by the ATRA. Including the therapy MPPR in calculating incurred expenses for therapy services furnished by CAHs treats CAH services consistently with services fu rnished in other applicable setti ngs. Therefore, therapy services furnished by CAHs during CY 2013 count towards th e therapy caps using the amount that would be payable under section 1834(k)(1)(B) of the Act, which includes an applicable MPPR. For a list of the “always therapy” codes subject to the therapy MPPR policy, see Addendum H of this final rule with comment period.

### CMS-1600-FC 560

The therapy cap amounts under section 1833(g) of the Act are updated each year based on the MEI. Specifically, the annual caps are calculated by updating the previous year’s cap by the MEI for the upcoming calendar year and rounding to the nearest $10 as specified in section 1833(g)(2)(B) of the Act. Increasing the CY 2013 therapy cap of $1,900 by the CY 2014 MEI of 0.8 percent, results in a therapy cap amount for CY 2014 of $1,920. An exceptions process for the ther apy caps has been in effect sin ce January 1, 2006. Originally required by section 5107 of the Deficit Reduction Ac t of 2005 (DRA), which amended section 1833(g)(5) of the Act, the exceptions process for the therapy caps has been continuously extended several times through subsequent legislation (MIEA-TRHCA, MMSEA, MIPPA, the Affordable Care Act, MMEA, TPTCCA, and MCTRJCA). Last amended by section 603(a) of the ATRA, the Agency’s current authority to provide an exceptions process for th erapy caps expires on December 31, 2013. After expenses incurred for the beneficiary’s services for the year have exceeded th e therapy caps, therapy suppliers and providers use the KX modifier on claims for services to request an exception to the therapy caps. By use of the KX modifier, the therapist is attesting that the services above the therapy caps are reasonable and necessary and that there is documenta tion of medical necessity for the services in the beneficiary’s medical record. Under section 1833(g)(5)(C) of the Act, whic h was added by the MCTRJCA and extended through 2013 by the ATRA, we are required to appl y a manual medical review process to therapy claims when a beneficiary’s incurred expenses exceed a th reshold amount of $3,700. There are two separate thresholds of $3,700, just as there are two therap y caps, and incurred expenses are counted towards the thresholds in the same manner as the caps. Under the statute, the required application of the manual medical review process expires December 31, 2013. For information on the manual medical review process, go to www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/MedicalReview/TherapyCap.html

. 2. Application of Therapy Caps to Services furnished by CAHs

### CMS-1600-FC 561

Section 4541 of the BBA amended section 1833(g) of the Act to create the therapy caps discussed above. This BBA provision applied the therapy caps to outpatient therapy services described at section 1861(p) of the Act except for the outpatient therapy services described in section 1833(a)(8)(B) of the Act. Section 1833(a)(8)(B) of the Act refers to ther apy services furnished by a hospital to an outpatient; to services furnished to a hospital inpatient who has exha usted, or is not entitled to , benefits under Part A; and to these same services when furnished by an entit y under arrangements with a hospital. Payment for the services described under section 1833(a)(8)(B) of th e Act is made under section 1834(k)(1)(B) of the

Act.

Section 4201 of the BBA amende d section 1820 of the Act to require a process for establishment of CAHs. Payment for CAH outpatient services is described under section 1834(g) of the Act. When we proposed language to implement the BBA provision establishing therapy caps in the CY 1999 PFS proposed rule, we indicated in the pream ble that the therapy caps do not apply to therapy services furnished directly or under arrangements by a hos pital or CAH to an outpatient or to an inpatient who is not in a covered Part A stay (63 FR 30818, 30858). We included a similar statement in the preamble to the final rule; however, we did not include the same reference to CAHs in that sentence in the CY 1999 PFS final rule with comment period (63 FR 5881 4, 58865). In the CY 1999 PFS final rule with comment period, we also stated generally that the therapy caps apply only to items and services furnished by nonhospital providers and therapis ts (63 FR 58865). In the CY 1999 proposed rule, we proposed to include provisions at §410.59(e)(3 ) and §410.60(e)(3) to describe, respectively, the outpatient therapy services that are exempt from the statutory therapy caps for outpatient OT services, and for outpatient PT and SLP services combined. Specifically, in the CY 1999 PFS proposed rule, we proposed to add the following regulatory language for OT and for PT at §410.59(e)(3) and §410.60(e)(3 ): “For purposes of applying the limitation, outpatient [occupational therap y/physical therapy] excludes services furnished by a hospital or CAH directly or under arrangements” (63 FR 30880). However, in the CY 1999 PFS final rule with comment period, the phrase “or CAH” was omitted from the final regulation text for OT in §410.59(e)(3), but was included in the final regulatio n text for PT in §410.60(e)(3). We note that for

### CMS-1600-FC 562

purposes of the therapy cap, outpatient PT services unde r our regulation at §410.60 include outpatient SLP services described under §410.62. As such, SLP ser vices are included in the references to PT under §410.60. Although the rulemaking history and regulati ons appear inconclusive as to whether outpatient therapy services furnished by CAHs were intende d to be subject to the therapy caps between January 1, 1999 and October 1, 201 2, we believe that we inadvert ently omitted the phrase “or CAH” in the CY 1999 final regulation for the occupational therap y cap. Moreover, we have consistently excluded all outpatient therapy services furnished by CAHs from the therapy caps over this time frame, whether the services were PT, SLP, or OT. Accordingly, from the outset of the therapy caps under section 1833(g) of the Act, therapy services furnished by CAHs have not been subject to the therapy caps. Thus, CAHs have not been required to use the exceptions process (including the KX modifier and other requirements) when furnishing medically necessary therapy services above the therapy caps; and therapy services furnished by

CAHs above the threshold amounts have not been su bject to the manual medical review process. Similarly, until section 603(b) of the ATRA amended the statute to specify the amount that must be counted towards the therapy caps and thresholds for ou tpatient therapy services furnished by CAHs in CY 2013, we did not apply towards the therapy caps or thresholds any amounts for therapy services furnished by CAHs. Therefore, we have consistently interp reted the statutory exclusion for outpatient therapy services furnished by hospital outpatient departments al so to apply to CAHs and implemented the therapy caps accordingly. As noted above, section 3005(b) of the MCTRJCA temporarily suspended the outpatient hospital services exemption from October 1, 2012 through Dece mber 31, 2012 (which has subsequently been extended through December 31, 2013 by the ATRA). As a result, from October 1, 2012 to the present,

CAH services have been treated di fferently than services furnished in other outpatient hospital settings. In implementing this change required by the MCTRJC A, we had reason to assess whether, as a result of the amendment, the therapy caps should be applied to outpatient therapy services furnished by CAHs.

We concluded that the MCTRJCA amendment did no t make the therapy caps applicable to services

### CMS-1600-FC 563

furnished by CAHs for which payment is made under section 1834(g) of the Act because it affected only the outpatient hospital services described under section 1833(a)(8)(B) of the Act for which payment is made under section 1834(k)(1)(B) of the Act. With the enactment in section 603(b) of the ATRA of specific language requiring us to count amounts towa rds the therapy caps and thresholds for services furnished by CAHs, we again had reason to assess wh ether the therapy caps apply to services furnished by CAHs. We concluded that the ATRA amendment did not explicitly make the therapy caps applicable to services furnished by CAHs, but directed us to count CAH services towards the caps. However, after reflecting on the language of section 1833(g) of the Act, we have concluded based upon the language of the Act that the therapy caps should be applied to outpatient therapy services furnished by CAHs. To explain further, under section 1833(g)(1) and (3) of the Act, the therapy caps are made applicable to all services described under section 186 1(p) of the Act except those described under the outpatient hospital services exemption. Section 1861( p) of the Act establishes the benefit category for outpatient PT, SLP and OT services, (expressly for PT services and, through section 1861(ll)(2) of the Act, for outpatient SLP services and, through section 1861( g) of the Act, for outpatient OT services). Section 1861(p) of the Act defines outpatient therap y services in the three disci plines as those furnished by a provider of services, a clinic, rehabilitation agency , or a public health agency, or by others under an arrangement with, and under the supervision of, such provider, clinic, rehab ilitation agency, or public health agency to an individual as an outpatient; and those furnished by a therapist not under arrangements with a provider of services, clinic, rehabilitation agen cy, or a public health agency. As such, section 1861(p) of the Act defines outpatient therapy servi ces very broadly to include those furnished by providers and other institutional settings, as well as those furnished in office settings. Under section 1861(u) of the Act, a CAH is a “provider of services.” As such, unless the outpatient therapy services furnished by a CAH fit within the outpatient hosp ital services exemption under section 1833(a)(8)(B) of the Act, the therapy caps would be applicable to PT, SLP, OT services furnished by a CAH. As noted above, section 1833(a)(8)(B) of the Act describes only outpatient therapy services for which payment is made under section 1834(k) of the Act. Payment for CAH services is made under section 1834(g) of the

### CMS-1600-FC 564

Act. Thus, the outpatient hospital services exempti on to the therapy caps under section 1833(a)(8)(B) of the Act does not apply, and the therapy caps are app licable, to outpatient therapy services furnished by a

CAH. However, we recognize that our current regulation specifically excludes PT and SLP services furnished by CAHs from the therapy caps, and our c onsistent practice since 1999 has been to exclude PT, SLP and OT services furnished by CAHs from the therapy caps. As such, in order to apply the therapy caps and related policies to services furnished by CAHs for CY 2014 and subsequent years, we believe we would need to revise our regulations. We proposed to apply the therapy cap limitati ons and related policies to outpatient therapy services furnished by a CAH beginning on January 1, 2014. In the proposed rule, we noted that not only do we believe this is the proper stat utory interpretation, but we also be lieve it is the appropriate policy. Under the existing regulations, with the suspension of the outpatient hospital services exemption through 2013, the therapy caps apply to outpatient therapy ser vices paid under Medicare Part B and furnished in all applicable settings except CAHs. We believe that outpatient therapy services furnished by a CAH should be treated consistently with outpatient thera py services furnished in all other settings. Therefore, we proposed to revise the therapy cap regulation at §410.60(e)(3) to remove the exemption for services furnished by a CAH and make conforming amendments. CAH outpatient therapy services are distinct from other outpatient therapy services in that outpatient therapy services furnished in office-based or other institutional settings are paid at the rates contained in the PFS, whereas CAHs are paid fo r outpatient therapy services under the methodology described under section 1834(g) of the Act. Beca use the CAH reasonable cost-based payment amounts are reconciled at cost reporting year-end, and are diff erent from the fee schedule-based payments for other outpatient therapy services, it might have been difficult to identify the amounts that we should have accrued towards the therapy caps for services furnished by CAHs. Therefore, prio r to 2013, not only did CMS not apply any caps to services provided by a CAH, but also did not count CAH services towards the caps. However, the ATRA amended the statute to require for outpatient therapy services furnished by

### CMS-1600-FC 565

CAHs during 2013 that we count towards the caps a nd the manual medical review thresholds the amount that would be payable for the services under Medicare Part B as if the services were paid as outpatient therapy services under section 1834(k)(1)(B) of the Act instead of as CAH services under section 1834(g) of the Act. We proposed to continue this me thodology of counting the amount payable under section 1834(k)(1)(B) of the Act towards the therapy cap and threshold for services furnished by CAHs in CY 2014 and subsequent years. We recognize that the outpatient hospital services exemption is suspended under current law only through December 31, 2013. If this provision is not extended, with our proposal to apply the therapy caps to services furnished by CAHs, effective January 1, 2014, therapy services furnished by CAHs would be treated differently than services furnished in other outpatient hospital settings. We recognize that the exceptions and manual medical review processes expi re on December 31, 2013 , and we would apply those polices to therapy services furnis hed by a CAH only if they are extended by statute. The exceptions process described above, including use of the KX modifier to attest to the medical necessity of therapy services above the caps and other requirements, if extended by legislation, would apply for services furnished by a CAH in the same way that it appli es to outpatient therapy services furnished by other facilities (except for any that are expressly exempted). Similarly, the manual medical review process for claims that exceed the $3,700 thresholds, if extende d by legislation, would apply to therapy services furnished by a CAH in the same way that they appl y for outpatient therapy services furnished by certain

other facilities. We proposed to amend the regulations establis hing the conditions for PT, OT, and SLP services by removing the exemption of CAH services from the therapy caps and specifyi ng that the therapy caps apply to such services. Specifically, we proposed to amend the regulations, which pertain to the OT therapy cap and the combined PT and SLP therapy cap , respectively, by including paragraph (e)(1)(iv) under §410.59 and (e)(1)(iv) under §410.60 to specify that (occupa tional/physical) therapy services furnished by a CAH directly or under arrangement s shall be counted towards the annual limitation on incurred expenses as if such services were paid under section 1834(k)(1)(B) of the Act. We also proposed

### CMS-1600-FC 566

to add new paragraph (e)(2)(v) to §410.59 and (e)(2)(vi) to §410. 60. These new paragraphs would expressly include outpatient (occupational/ physical) therapy services furnished by a CAH directly or under arrangements under the description of services to wh ich the annual limitation applies. Further, we proposed to amend the regulation at §410.60(e)(3), which currently excludes services furnished by a CAH from the therapy cap for PT and SLP servi ces, to remove the phrase “or CAH.” The following is a summary of the comments we received regarding the proposal to apply the therapy cap limitations and relate d policies to outpatient therapy services furnished by a CAH beginning on January 1, 2014. We received many comment s from professional therapy associations, hospital associations, health systems, nonprofit health care orga nizations, and specialty pr ovider groups regarding our proposal, all of which opposed the application of the therapy caps to CAH services. A summary of the reasons stated for opposition follow.

Comment : Most of the comments we received argued that due to the critical role that CAHs play in furnishing healthcare services in underserved or ru ral areas, imposing the financial and administrative burden of the therapy caps on CAHs would result in Me dicare beneficiaries having fewer, if any, options for accessing needed therapy services in CAH servi ce areas. A few commenters noted that Congress established the CAH designation in order to make health care services accessible to Medicare

beneficiaries in rural areas who would otherwise be unable to access hospital services and argued that our proposed policy would be contrary to Congress’s goal. Commenters noted that those most affected by this policy are beneficiaries living in rural areas who are on average older, sicker, poorer, and more geographically isolated compared to individuals in ur ban areas. Commenters pointed out that in rural or underserved areas therapy services enable beneficiarie s to recover and reconstruct their lives after experiencing medical emergencies such as a stroke. Commenters also noted that if a therapy cap exceptions process is not in place, our proposed policy w ould result in Medicare beneficiaries either being financially liable for additional services or foregoing medically necessary services. Several commenters stated that this proposal would place an unnecessary burden on CAHs since it was unlikely that applying

### CMS-1600-FC 567

the therapy caps to CAHs would result in significan t cost savings or reduce unnecessary care; and some even said that our proposed policy would actua lly increase costs for the Medicare program. 

### Response : After reassessing our interpretation of section 1833(g) of the Act under our proposed policy, we continue to conclude that the proper statutory inte rpretation would be to apply the therapy caps and related provisions to outpatient th erapy services furnished by CAHs. We agree with commenters that CAHs provide important access to medically necessary therapy

services for Medicare beneficiar ies; however, we do not believe th at application of the therapy caps and related policies to services furnished by CAHs will lead to significant new impediments for Medicare beneficiaries. Under our proposed policy, CAHs would be subject to the therapy caps, as well as any potential extension of th e therapy caps exceptions and manual medical review processes, in the same ma nner as other providers of thera py services except for those that are specifically exempted by statute from applic ation of the caps and related provisions. As such, the therapy caps and related provisions would affect therapy services furnished by a CAH and other providers of such services in a comp arable degree. We also do not believe that applying the therapy caps to servi ces furnished by CAHs would nega tively affect the ability of CAHs to furnish therapy services to Medicare bene ficiaries. We believe that any increase in the administrative burden presented by the thera py caps and, if extended by legislation, the exceptions and manual medical review processes, will be only minor. As we explained in the proposed rule and noted above, we believe the prope r interpretation of the st atute requires us to apply the therapy caps to services furnished by CAHs.

Comment : We received a few comments stating that the drawbacks of the therapy caps would be exacerbated by applying this policy to additional provider settings. Most of these commenters argued that the ther apy cap has been problematic since its inception. One

### CMS-1600-FC 568

commenter suggested that, instead of applying the therapy caps to CAHs, we should develop an alternative policy to replace the cap. Response : The therapy caps are mandated by statut e and we do not have authority to repeal the caps. As such, we will continue to apply the statutorily mandated therapy caps as specified under the statute whic h, as we have discussed above, includes applying the therapy caps policy to CAHs.

Comment : We received several comments stating that our current policies, in addition to our proposed regulations, overly co ntrol the utilization of therapy services . Most of these commenters noted that under §409.17 of the regula tions, therapy services are required to be ordered by a physician prior to a qualified profes sional initiating a plan of care, and these commenters argued that the requirement for an order can control utilization of therapy services in

CAHs. One commenter noted that the direct s upervision policy expressed in the CY 2014 OPPS proposed rule coupled with our proposal would caus e services in CAHs to be overregulated. Response : We disagree with commenters that CAHs are overregulated with respect to outpatient therapy services. We do not believe our proposed policy overregulates CAH services as compared to other providers of therapy serv ices. We also do not believe that §409.17 requires an order for outpatient thera py services in a CAH as suggested by the commenters. This regulation requires that a qualified professional pursuant to a plan of care furnish PT, OT, or SLP services, which is not the same as an order. Section 409.17 does not prov ide for any utilization control or limits on the quantity of outpatient th erapy services furnished by CAHs, but rather assures that therapy is furnishe d under a plan of care by a qualif ied professional. Further, as explained above, we believe that proper interpre tation of the statute re quires us to apply the therapy caps and related provisions to therapy services furnished by CAHs. As such, the therapy

### CMS-1600-FC 569

caps and related provisions would have a compar able effect on therapy services furnished by a CAH and those furnished by other therapy services providers (unless they are exempted by statute from the application of the caps).

Comment : We received numerous comments sta ting that our proposal resulted from a misinterpretation of the ATRA, and that it is preferable policy to treat CAHs and hospitals similarly for the purpose of the therapy caps. Several commenters believed that we have misinterpreted the language of the ATRA to concl ude that the therapy caps should be applied to services furnished by CAHs. Commenters noted that the ATRA specifies a proxy value to accrue therapy services furnished by CAHs toward the caps, but doe s not indicate that we should count this value beyond December 31, 2013, or th at we should generally subject services furnished by CAHs to the therapy caps. Most of these commenters argue d that if Congress had intended to apply the therapy cap to CAHs, it woul d have explicitly indica ted in the ATRA that CAHs should be subject to the th erapy caps. One commenter rais ed concern that “the proposed change is unlawful” since the ATRA neither requ ires, nor allows the Secretary to revise the federal regulations to permanently subject to the caps outpatient therapy services furnished by

CAHs.

Most commenters said that we should trea t CAHs and outpatient hospital departments similarly with regard to the therapy caps by c ontinuing to exclude services furnished by CAHs (presumably to the extent such exclusion is re quired by statute). Commenters argued that a CAH is intended to be “provider of services” by furnis hing inpatient and outpatient hospital services in areas where care is severely lim ited and thereby acts as a “hosp ital” in the areas that it serves

. One commenter believed that our interpretation of the exemption from the therapy caps of outpatient therapy services described under se ction 1833(a)(8)(B) of the Act and paid under

### CMS-1600-FC 570

section 1834(k)(1)(B) of the Act is misguided si nce the exemption only describes the provider type rather than the provider type and payment methodology for those services. As evidence for this reasoning, the commenter noted that ski lled nursing facilities (SNFs), comprehensive outpatient rehabilitation facilitie s (CORFs), rehabilitation agenci es, and home health agencies, described under section 1833(a)(8 )(A) of the Act and paid unde r section 1834(k)(1)(B) of the Act, are not exempt from th e therapy caps. The commenter suggested that we make a determination that, based on the statutory defini tion in section 1861(e) of the Act, a CAH is a hospital in the context of applyi ng the therapy caps, and interpret the hospital services exemption from the therapy caps to include CAHs. Response : We agree with commenters that the ATRA does not direct or require us to apply the therapy caps to services furnished by CAHs. As noted above, we agree that the ATRA only directed us to count therapy services furn ished by CAHs towards the caps. However, the ATRA is not the basis of the proposed change to our regulations. Rather , we based our proposed change on our reassessment of language of sectio n 1833(g) of the Act as added by the BBA. After considering the comments concerning our interpretation of section 1833(g) of the Act, we again reassessed the statut e and reviewed the rationale for our proposal. We continue to conclude that our proposal to revise our regulations to appl y the therapy caps to services furnished by CAHs reflects the proper interpreta tion of section 1833(g) of the statute. We

continue to believe that thera py services furnished by a CAH and paid under section 1834(g) of

the Act are not described under section 1833(a)(8)(B) of the Act and thus do not meet the requirements of the outpatient hospital exemption. Rather, as we explained in the proposed rule, the outpatient hospital services exemption relates to the specific services described under section 1833(a)(8)(B) of the Act, which delineates both the entities that furnis h the services and the

### CMS-1600-FC 571

manner in which those services are paid. We acknowledge the commenter’s recognition that therapy services furnished by rehabilitation agen cies, CORFs, SNFs, and home health agencies (some of which are also considered “provide rs of services” along with CAHs under section 1861(u) of the statute) are s ubject to the therapy caps ev en though they are paid under 1834(k)(1)(B) of the Act, as are hospitals. However, th e providers mentioned by the commenters are described under section 1833(a) (8)(A) of the Act ra ther than section 1833(a)(8)(B) of the Act. The outpatient hospita l services exemption onl y applies to services described under section 1833(a)(8)(B ) of the Act. We believe that the statute explicitly exempts only services described under se ction 1833(a)(8)(B) of the Act, which does not include any services for which payment is no t made under section 1834(k)(1)(B) of the Act. We continue to believe that neither services furnished by CAHs, nor those furnished by SNFs, CORFs, rehabilitation agencies, and home health agen cies, fall under that exemption. Regardless of whether we consider a CAH as a “hospital” for purposes of the therapy caps, therapy services furnished by CAHs are not described under sectio n 1833(a)(8)(B) of the Act and, as such, do not fall within the scope of the outpatient hospital services exemption from the therapy caps. Therefore, we continue to believe that the outp atient hospital services exemption to the therapy caps under section 1833(g)(1) and (3) of the Act doe s not apply to outpatient therapy services furnished by a CAH.

Comment : Commenters expressed concern that therapy services furnished by CAHs after January 1, 2014 would be treated differently than therapy services furnished by outpatient hospital departments although both entities are s ubject to the same regulations regarding outpatient therapy services.

### CMS-1600-FC 572

Response : Although we believe it would be pref erable policy to treat all outpatient therapy services furnished in all settings cons istently, we continue to believe the proper interpretation of the statute requires applica tion of the therapy caps and related policies to services furnished by CAHs. As a result, if the outpatient hospital services exemption is no longer suspended by legislation, there may be diff erences in the application of the statutory therapy caps and related provisions betw een outpatient hospitals and CAHs. After consideration of all comments, we are finalizing our proposal. As proposed, we are including paragraph (e)(1)(iv) under both §410.59 and §410.60 to specify that outpatient occupational therapy, physical therapy and sp eech-language pathology se rvices furnished by a CAH directly or under arrangements shall be co unted towards the annual limitation on incurred expenses as if such services were paid under section 1834(k)(1)(B) of the Act. In order to improve clarity that PT and SLP services are co mbined for the purposes of applying the cap, but not to change the substance of the current regulations or the pr oposed changes to the regulations, we are making a modification to the proposal. Specifically, we are adding the phrase “and speech-language pathology” to the text in §410.60(e)(1)(iv). Also as proposed, we are adding new paragraph (e)(2)(v) to §410.59 and (e)(2)(v i) to §410.60. These new paragraphs will expressly include outpatient occupational th erapy, physical therapy and speech-language pathology services furnished by a CAH directly or under arrangements in the description of services to which the annual limitation applie s. Lastly, as proposed, we are amending the regulation at §410.60(e)(3), which currently exclud es services furnished by a CAH from the therapy cap for PT and SLP services , to remove the phrase “or CAH.” We received a number of comments that were not related to our proposal to amend our regulations to specify that the therapy caps and related provisions are applicable to therapy

### CMS-1600-FC 573

services furnished by a CAH. These comments pertained to repeal of the therapy caps, the therapy caps exceptions process, the manual medi cal review process, the therapy MPPR, and Functional Reporting. Because we made no proposals regarding these subjects, these comments are outside of the scope of the proposed rule and, therefore, are not addres sed in this final rule with comment period.

### CMS-1600-FC 574

J. Requirements for Billing “Incident To” Services 1. Background 

### Section 1861(s)(2)(A) of the Act establishes th e benefit category for services and supplies furnished as incident to the pr ofessional services of a physicia n. The statute specifies that “incident to” services and supplies are “of kinds which are commonly furnished in physicians’ offices and are commonly either rendered without charge or included in physicians’ bills.” In addition to the requirements of the statut e, our regulation at §410.26 sets forth specific requirements that must be met in order for physicia ns and other practitioners to bill Medicare for incident to physicians’ services. Section 410.26( a)(7) limits “incident to ” services to those

included under section 1 861(s)(2)(A) of the Act and that are not covered under another benefit category. Section 410.26(b) specifie s (in part) that in order for se rvices and supplies to be paid

as “incident to” services under Medicare Part B, the services or supplies must be:

● Furnished in a noninstitutional set ting to noninstitutio nal patients.

● An integral, though incidental, part of the service of a physician (o r other practitioner) in the course of diagnosis or trea tment of an injury or illness.

● Furnished under direct supervis ion (as specified under §410.26(a)(2)) of a physician or other practitioner eligible to bill and directly receive Medicare payment.

● Furnished by a physician, a pr actitioner with an “incident to” benefit, or auxiliary personnel. In addition to §410.26, there are regulations specif ic to each type of practitioner who is

allowed to bill for “incident to” services. Th ese are found at §410.71(a)(2) (clinical psychologist services), §410.74(b) (physician as sistants’ services), §410.75(d) (nur se practitioners’ services), §410.76(d) (clinical nurse special ists’ services), and §410.77(c) (certified nurse-midwives’

### CMS-1600-FC 575

services). When referring to pr actitioners who can bill for servi ces furnished incident to their professional services, we are referring to physicians and these practitioners. “Incident to” services are treated as if they were furnished by the billing practitioner for purposes of Medicare billing and payment. Cons istent with this termi nology, in this discussion when referring to the practitioner furnishing the se rvice, we are referring to the practitioner who is billing for the “incident to” se rvice. When we refer to the “auxiliary personnel” or the person who “provides” the service, we are referring to an individual who is pe rsonally performing the service or some aspect of it as distinguished fr om the practitioner who bills for the “incident to”

service.

Since we treat “incident to” services as se rvices furnished by th e billing practitioner for purposes of Medicare billing and payment, paym ent is made to the bi lling practitioner under the PFS, and all relevant Medicare rules apply includ ing, but not limited to, requirements regarding medical necessity, documentation, and billing. Those practitioners who can bill Medicare for “incident to” services are paid at their applicable Medicare payment rate as if they furnished the service. For example, when “incident to” servic es are billed by a physician, they are paid at 100 percent of the fee schedule amount, and when the services are billed by a nurse practitioner or clinical nurse specialist, they are paid at 85 percent of th e fee schedule amount. Payments are subject to the usual deductible and coin surance amounts. As the services commonly furnished in physic ians’ offices and other nonfacility settings have expanded to include more co mplicated services, the types of services that can be furnished “incident to” physicians’ services have also expanded. St ates have increasingly adopted standards regarding the delivery of health care services in a ll settings, including physicians’ offices, in order to protect the health and safety of their citizens. Th ese state standards often

### CMS-1600-FC 576

include qualifications for the individuals who are permitted to furnish specific services or requirements about the circumstances under whic h services may actually be furnished. For example, since 2009, New York has required that o ffices in which surgery is furnished must be accredited by a state-approved accredited agency or organization. Similarly, Florida requires certain standards be met when surgery is furnis hed in offices, including that the surgeon must “examine the patient immediately before the surgery to evaluate the risk of anesthesia and of the surgical procedure to be perfor med” and “qualified anesthesia personnel shall be present in the room throughout the conduct of all general anes thetics, regional anesthetics and monitored

anesthesia care.” Over the past years, several situations have come to our attention where Medicare was billed for “incident to” services that were pr ovided by auxiliary personnel who did not meet the

state standards for those services in the state in which the services were furnished. The physician or practitioner billing for the services would have been permitted under state law to personally furnish the services, but the services were pr ovided by auxiliary personnel who were not in compliance with state law in providing the partic ular service (or aspect of the service).

Practitioners authorized to bill Medicare for services that they furnish to Medicare beneficiaries are required to comply with state law when furnishing services for which Medicare will be billed. For example, section 1861(r) of the Ac t specifies that an individual can be considered a physician in the performance of any function or action only when legally authorized to practice in the particular field by the state in which he performs such function or action. Section 410.20(b) of our regulations provides that payment is made for services only if furnished by a doctor who is “...legally author ized to practice by the State in which he or she performs the functions or actions, and who is act ing within the scope of his or her license.” Similar statutory

### CMS-1600-FC 577

and regulatory requirements exist for nonphysic ian practitioners. For example, section 1861(s)(2)(K)(i) of the Act, whic h provides a benefit category for services of a physician assistant (PA), includes only servic es that the PA is “...legally au thorized to perform by the State in which the services are performed...”, and §410.74(a )(2)(ii) of our regulati ons provides that the services of a PA are covered only if the PA is “...legally authorized to perform the services in the State in which they are performed...” Ther e are similar statutory and regulatory provisions for nurse practitioner services (1861(s)(2)(K)(ii) , §410.75(b)), certified nurs e specialist services (1861(s)(2)(K)(ii), §410.76(b)), qualified psychologi st services (1861(s)(2 )(M), §410.71(a)), and

certified nurse-midwife servic es (1861(s)(2)(L), §410.77(a)(1)). However, the Medicare requirements for serv ices and supplies inci dent to a physician’s professional services (§410.26 discussed above), do not specifically make compliance with state law a condition of payment for serv ices (or aspects of services) a nd supplies furnished and billed as “incident to” services. Nor do any of the regul ations regarding services furnished incident to the services of other practitione rs contain this requirement. Thus, Medicare has had limited

recourse when services furnished incident to a physician’s or practiti oner’s services are not furnished in compliance with state law. In 2009, the Office of Inspector General i ssued a report entitle d “Prevalence and Qualifications of Nonphysicians Who Perfor med Medicare Physician Services” (OEI-09-06- 00430) that considered in part the qualifications of auxiliary personnel who provided incident to physician services. This report f ound that services being billed to Medicare were provided by auxiliary personnel. After finding that services were being provided by auxiliary personnel “. . .who did not possess the required li censes or certifications accor ding to State laws, regulations,

and/or Medicare rule” and billed to Medicare the OIG recommended that we revise the “incident

### CMS-1600-FC 578

to” rules to, among other things, “...require that physicians who do not personally perform the services they bill to Medicare ensure that no persons except... nonphysicians who have the necessary training, certification, and/or licensure, pursuant to St ate laws, State regulations, and Medicare regulations personally perform the serv ices under the direct s upervision of a licensed physician.” 2. Compliance with State Law To ensure that auxiliary personnel providing services to Medicare be neficiaries incident to the services of other practitioners do so in accordance with the requirements of the state in

which the services are furnished and to ensure that Medicare payments can be denied or

recovered when such services are not furnished in compliance with the state law, we proposed to add a requirement to the “inciden t to” regulations at §410.26, Servi ces and supplies incident to a physician’s professional services: Conditions. Specifically, we proposed to amend §410.26(b) by redesignating paragraphs (b)(7 ) and (b)(8) as paragraphs (b)(8 ) and (b)(9), respectively, and by adding a new paragraph (b)(7) to state that “Services and s upplies must be furnished in accordance with applicable State law.” We also proposed to amend the definition of auxiliary personnel at §410.26(a)(1) to require that the individual providing “incident to” se rvices “meets any applicable requirements to provide the services, including licensure, im posed by the State in which the services are being furnished.” 3. Elimination of Redundant Language In addition, we proposed to eliminate redundant and potentially inc ongruent regulatory language by replacing the specific “incident to ” requirements currently contained in the regulations relating to each of the various types of practitione rs with a reference to the requirements of §410.26. Specifically, we proposed to:

### CMS-1600-FC 579

● Revise §410.71(a)(2) regarding clinical psychologists’ services to read “Medicare Part B covers services and supplies incident to the services of a clinical psychologist if the requirements of §410.26 are met.”

● Revise §410.74(b) regarding physician assist ants’ services to r ead “Medicare Part B covers services and supplies inci dent to the services of a physic ian assistant if the requirements of §410.26 are met.”

● Revise §410.75(d) regarding nurse practitioners’ services to read “Medicare Part B covers services and supplies incide nt to the services of a nurse pr actitioner if the requirements of §410.26 are met.”

● Revise §410.76(d) regarding certified nurse specialists’ services to read “Medicare Part B covers services and supplie s incident to the services of a clinical nurse specialist if the requirements of §410.26 are met.”

● Revise the language in §410.77(c) regarding ce rtified nurse-midwives’ services to read

“Medicare Part B covers services and supplies incident to the services of a certified nursemidwife if the requirements of §410.26 are met.” We noted in the proposed rule that these practi tioners are, and would continue to be under this proposal, required to comply with the regulation at §410.26 for services furnished incident to their professional services. We believe it is redu ndant and potentially confusing to have separate regulations that generally rest ate the requirements for “incid ent to” services of §410.26 using slightly different terminology. We stated that our goal in propos ing the revisions to refer to §410.26 in the regulation for each practitioner’s “incident to” services was to reduce the regulatory burden and make it less difficult for pr actitioners to determine what is required. Reconciling these regulatory require ments for physicians and all other practitioners who have the

### CMS-1600-FC 580

authority to bill Medicare for “incident to” services is also consistent with our general policy to treat nonphysician practitioners si milarly to physicians unless there is a compelling reason for disparate treatment. We noted that we believed that this proposal made the requirements clearer for practitioners furnishing “incident to” serv ices without eliminating existing regulatory requirements or imposing new ones and welcomed comments on any requirements that we may have inadvertently overlooked in our proposed revisions, or any benefit that accrues from continuing to carry these separate regulatory requirements. 4. Rural Health Clinics and Federal Qualified Health Centers The regulations applicable to Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) have similar “incident to” rules, and we proposed to make conforming changes to these regulations. Specifically, we proposed to revise §405.2413(a), which addresses services and supplies incident to physicians’ services for RHCs and FQHCs, by redesignating paragraphs (a)(4) and (a)(5) as paragraphs (a)( 5) and (a)(6), respectively and by adding a new paragraph (a)(4) that states se rvices and supplies must be furnished in accordance with applicable state law. Additionally, we proposed to amend §405.2415(a), which addresses

services incident to nurse practitioner a nd physician assistant services by redesignating paragraphs (a)(4) and (a)(5) as paragraphs (a)( 5) and (a)(6), respectively and by adding a new paragraph (a)(4), which specifies services and supplies must be furnished in accordance with applicable state law. We proposed to am end §405.2452(a), which addresses services and supplies incident to clinical ps ychologist and clinical social worker services by redesignating paragraphs (a)(4) and (a)(5) as paragraphs (a)( 5) and (a)(6), respectively and by adding a new paragraph (a)(4), which states services and suppl ies must be furnished in accordance applicable

### CMS-1600-FC 581

state law. Finally, we also proposed the removal of the word “personal” in §405.2413, §405.2415, and §405.2452 to be consistent with the “incident to” prov isions in §410.26. The following is a summary of the comments we received regarding the proposal to amend our regulations to include the requirement th at “incident to” services must be furnished in accordance with applicable state law.

Comment : The vast majority of commenter s supported requiring compliance with applicable state law as a condition of paymen t for “incident to” serv ices. Many of these commenters noted that adoption of this regulation would increase quality of care and safety for

Medicare beneficiaries and ensure that funds dedicated to servi ces and supplies ar e appropriately utilized. We received only two comments opposing the adoption of a condition of payment requiring compliance with state laws. One of th ese stated that since at least 1997, Medicare has had a “demonstration project” that has tested th e effects of lifting stat e scope of practice restrictions, and that with this proposed regulation we are abrup tly ending this demonstration

without an assessment of the eff ects of such action. The other st ated that this regulation was unnecessary because section 1156 of the Act requires health care practitioners to ensure that

“...the services it furnishes are of a quality that meets professi onal standards of care....” Some who supported the concept of our proposal suggest ed that the condition of payment only require compliance with state laws relating to training, cert ification, and/or licensure . In support of this suggestion, a commenter noted that the broader re quirement of compliance with any applicable state laws would allow CMS to deny Medicare paymen t for technical violations of state laws that are not targeted at patient health or safety, ev en when care was appropriately delivered and the quality of care not affected. One commenter poi nted out that our regul ations if revised as proposed would put providers at risk of havi ng to defend False Claims Act actions brought on

### CMS-1600-FC 582

the theory that the provider improperly billed for services based on a minor defect with the physician or other practitioner’s licen se or certification; and, in tu rn that this minor defect is unrelated to the quality of care furnished and out side the scope of practi ce and should therefore not result in the risk of possible False Claims Act allegations. Response : After consideration of the comments, we are finali zing our proposal to adopt a new condition of payment imposing a requirement to comply with state laws for services furnished incident to a physician’s or other practitioner’s professional services. We believe this requirement will protect the health and safety of Medicare beneficiaries and enhance our ability

to recover federal dollars when care is not delivered in accordance with state laws

. In response to concerns that the proposal should be limited to state laws relating to who could perform the services, such as scope of prac tice or licensure laws, we believe that there are many and varied state laws that would protect the safety and health of Medicare beneficiaries. As such, we do not believe it would be prudent to limit the appli cability as suggested. In response to the commenter’s concern regarding tech nical and unintended violations of state laws, it is important that CMS only pays for services furnished in acco rdance with state law. In an effort to ensure

that services are furnished in accordance with st ate law, it is expected that practitioners are cognizant of the qualifications of any individuals who provide serv ices incident to the physician (or other practitioner). With regard to the commen t stating that this regulation is unnecessary based on section 1156 of the Act, we note that complian ce with section 1156 is a condition of eligibility and not an explicit basis for CMS to deny or rec over payments for services furnished incident to services of a physician (or other practitioner) wher e services are not furnished in accordance with state law. After reviewing the co mments we conclude that it is beneficial to make explicit as a condition of payment for “incident to” services the requirement to comply with state law. The fact

### CMS-1600-FC 583

that another provision of the law might also be relevant to the situation does not mean that both are not appropriate or beneficial to the program. With regard to th e comment that we are ending a demonstration project that has existed since at least 1997 without an assess ment, we disagree. We are unaware of any such de monstration project either currently underway, or undertaken in the past. Moreover, as we noted in the proposed rule, practitioners furnishing services to Medicare beneficiaries are not exempt from complying with state law.

Comment : Several commenters, including some who supported our proposal, expressed concern about enforcement and expanding the admi nistrative burden on Medi care practitioners. Suggestions were made that we be transparent in implementing the provision and provide ample education on the policy and how it will be enforced. One commenter asked that we “...take into account the already significant ad ministrative burden that phys icians face under Medicare, and avoid adding to that burden.” Another commente r urged us to work with medical societies, particularly those representing practitioners in rural communities, to ensure the policy is well understood and does not impede beneficiary access to care. It was further suggested that we should know who is actually providing services or at least when se rvices are provided “incident to” the billing professional’s services, and that we cons ider implementing the OIG’s recommendation to require the use of modifi ers on the claim when reporting “incident to”

services. Response : We do not believe that this c ondition of payment would increase the administrative burden on practitioners as practitione rs are already expected to comply with state law. As we have discussed above, we believe th at this provision enhances our ability to deny or recover payments when the condition is not met. With regard to the suggestion that we impose a requirement for practitioners to bill “incident to” services using a modifier, we do not believe

### CMS-1600-FC 584

that a modifier requirement would assist in impl ementing or enforcing this condition of payment. Since a modifier requirement w ould not assist us in implemen ting this provision, we are not adopting one at this time. We would also note that there are impediments to imposing a modifier requirement at this time, including that a modifi er and required definitions for use of a modifier do not exist. With regard to informing those a ffected by this change in regulations, we will use

our usual methods to alert stakeholders of this new condition of payment and feel confident that the information will be efficiently and effectively disseminated to those who need it.

Comment : One commenter pointed out that stat es can and do punish individuals for furnishing services inappropriate ly, and that CMS should therefor e leave it to the states to

determine whether or when services are provided by an unlicensed professional. Response : We agree with this commenter that it is primarily the respon sibility of states to develop and enforce complian ce with licensure laws for hea lth care professionals, and note that nothing in this proposal would impede the st ates’ ability to do so. Nor would anything in this proposal duplicate the states’ activities in this arena. Rather, this proposal would reinforce the states’ laws by providing e xplicit authority to limit Medicare payment for “incident to”

services to those furnished in accordance with state laws. As noted above, in the absence of our proposed regulation, situations c ould arise where Medicare would otherwise make payment for

services not furnished in accordance with state law. Such situations are not consistent with our recognition of states as principle regulators of health care practic es for the protection and benefit of their citizens. The adoption of compliance with state law as a condition of Medicare payment allows us to deny, or if already paid, recove r payment when services are not furnished in compliance with state law and t hus supports state activities.

### CMS-1600-FC 585

Comment : A commenter suggested that we eliminate the new proposed §410.26(b)(7), which requires that “incident to” services be pr ovided in compliance with applicable state law, because it was redundant with §410.26(a)(1). Response : Section 410.26(a)(1) de fines “Auxiliary personnel” whereas §410.26(b)(7) provides the conditions that must be met for Medicar e Part B to pay for services and supplies. It is therefore not redundant, but instead necessary , to both define auxiliary personnel and to include the specific requirements that must be met. In addition to the comments discussed above, we received several comments regarding

the “incident to” benefit that were not within the scope of our proposal. Specifically, we received requests to expand the types of pract itioners who are allowed to bill Medicare for

“incident to” services an d to limit auxiliary perso nnel under our “incident to” regulations to those who cannot bill Medicare directly for their services. Not only are these comments outside the scope of this regulation, but in most respects they are addressed by the Medicare statute and

outside our discreti on to change. After consideration of public comments rega rding our proposed rule, we are finalizing the changes to our regulations as proposed. The specific regul atory changes being made are

described below. Specifically, we are amending §410.26(a)(7), which defines “auxiliary personnel” to add “and meets any applicable requirements to provide the services, including licensure, imposed by the State in which the services are being furnished.” In §410.26(b) we are redesignating paragraphs (b)(7) and (b)(8) as pa ragraphs (b)(8) and (b)(9), respectively, and adding a new paragraph (b)(7) to state that “S ervices and supplies must be furnished in accordance with applicable State laws;”.

### CMS-1600-FC 586

In addition, we are finalizing our proposal to eliminate redundant and potentially incongruent regulatory language by replacing the specific “inciden t to” requirements currently contained in the regulations relating to each of th e various types of practi tioners with a reference to the requirements of §410.26. Specifically, we are:

● Revising §410.71(a)(2) regard ing clinical psychologist se rvices to read “Medicare Part B covers services and supp lies incident to the services of a clinical psychologist if the requirements of §410.26 are met.”

● Revising §410.74(b) regarding ph ysician assistants’ services to read “Medicare Part B covers services and supplies inci dent to the services of a physic ian assistant if the requirements of §410.26 are met.”

● Revising §410.75(d) regarding nurse practitione rs’ services to read “Medicare Part B covers services and supplies incide nt to the services of a nurse pr actitioner if the requirements of §410.26 are met.”

● Revising §410.76(d) regarding cl inical nurse specialists’ se rvices to read “Medicare Part B covers services and supplie s incident to the services of a clinical nurse specialist if the requirements of §410.26 are met.”

● Revising the language in §410.77(c) regardi ng certified nurse-midwives’ services to

read “Medicare Part B covers serv ices and supplies incident to th e services of a certified nursemidwife if the requirements of §410.26 are met.” We are also revising the regul ations applicable to RHCs and FQHCs to make similar changes. Specifically, we are revising §405.2413( a), which addresses services and supplies incident to physicians’ services for RHCs a nd FQHCs, by redesignating paragraphs (a)(4) and (a)(5) as paragraphs (a)(5) and (a)(6), respec tively and by adding a new paragraph (a)(4) that

### CMS-1600-FC 587

states “Services and supplies must be furnishe d in accordance with applicable State laws;”. Additionally, we are amending §405.2415(a), which addresses services incident to nurse practitioner and physician assistan t services by redesignating para graphs (a)(4) and (a)(5) as paragraphs (a)(5) and (a)(6), re spectively and by adding a new pa ragraph (a)(4) that “Services and supplies must be furnished in accordance wi th applicable State laws;”. We are amending §405.2452(a), which addresses services and supplie s incident to clini cal psychologist and

clinical social worker servi ces by redesignating paragraphs (a )(4) and (a)(5) as paragraphs (a)(5) and (a)(6), respectively and by adding a new paragraph (a)(4 ) that states “Services and supplies must be furnished in accordance with applicable State laws.” Finally, we are removing the wo rd “personal” in §405.2413, §405.2415, and §405.2452

to be consistent with the “inc ident to” provisions in §410.26 Servic es and supplies incident to a physician’s professional services: Conditions. The changes being adopted in this final rule with comment period are consistent with the traditional approach of relying primarily on the stat es to regulate the health and safety of their residents in the delivery of h ealth care services. Throughout the Medicare program, and as evidenced by several examples a bove, the qualifications required for the delivery of health care services are generally determined with reference to state law. As discussed above, our current regulations governing practitioners billing Medicare for services personally furnished include a basic requirement to comply with state law when furnishing Medicare covered services. However, the Medicare regulations for “inciden t to” services and suppl ies did not specifically make compliance with state law a condition of pa yment for services and supplies furnished and billed as incident to a practitione r’s services. In addition to hea lth and safety benefits that we believe will accrue to Medicare beneficiaries, th ese changes will help to assure that federal

### CMS-1600-FC 588

dollars are not expended for servic es that do not meet the standard s of the states in which they are being furnished while providing the ability fo r the federal government to recover funds paid where services and supplies are not furnis hed in accordance with these requirements.

### CMS-1600-FC 589

K. Chronic Care Management (CCM) Services

As we discussed in the CY 2013 PFS final rule with comment period, we are committed to supporting primary care and we have increasingly r ecognized care management as one of the critical components of primary care that contributes to bette r health for individuals and reduced expenditure growth (77 FR 68978). Accordingly, we have priori tized the development and implementation of a series of initiatives designed to improve payment for, and en courage long-term investme nt in, care management

services. These initiatives include the fo llowing programs a nd demonstrations:

● The Medicare Shared Savings Program (descr ibed in “Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule'' which a ppeared in the November 2, 2011 Federal Register (76 FR 67802)).

● The testing of the Pioneer ACO model, desi gned for experienced health care organizations (described on the Center for Medicare and Medicaid Innovation’s (Innovation Center's) website at innovations.cms.gov/initiatives/ACO/Pioneer/index.html ).

● The testing of the Advance Payment AC O model, designed to support organizations participating in the Medicare Shared Savings Program (described on the Innovation Center’s website at innovations.cms.gov/initiatives/AC O/Advance-Payment/index.html ).

● The Primary Care Incentive Payment (PCIP) Program (described on the CMS website at www.cms.gov/Medicare/Medicare-Fee-for-Service-Pa yment/PhysicianFeeSched/Downloads/PCIP-2011- Payments.pdf ).

● The patient-centered medical home model in the Multi-payer Advanced Primary Care Practice (MAPCP) Demonstration designed to test whether the quality and coordination of health care services are improved by making advanced primary care practices more broadly available (described on the CMS

website at www.cms.gov/Medicare/DemonstrationProjects/DemoProjectsEvalRpts/downloads/mapcpdemo_Factsheet.pdf ).

● The Federally Qualified Health Center (FQHC) Advanced Primary Care Practice demonstration (described on the CMS website at www.cms.gov/Medicare/Demonstration-

### CMS-1600-FC 590

Projects/DemoProjectsEvalRpts/downloads/mapcpdemo_Factsheet.pdf and the Innovation Center’s

website at innovations.cms.gov/initiatives/FQHCs/index.html ).

● The Comprehensive Primary Care (CPC) in itiative (described on the Innovation Center’s

website at innovations.cms.gov/initiatives/Comprehens ive-Primary-Care-Initiative/index.html ). The CPC initiative is a multi-payer initiative fostering collaborati on between public and private health care payers to strengthen primary care in certain markets across the country. In addition, HHS leads a broad initiative focused on optimizing health and quality of life for individuals with multiple chronic conditions. HHS’ Strategic Framewor k on Multiple Chronic Conditions outlines specific objectives and strategies for HHS and pr ivate sector partners centered on strengthening the health care and public health systems; empow ering the individual to use self-care management; equipping care providers with tools, information, and other interventions; and supporting targeted research about individuals with multiple chronic conditions and effective interventions. Further

information on this initiative can be found on the HHS website at http://www.hhs.gov/ash/initiatives/mcc/index.html. In coordination with all of these initiatives, we also have continued to explore potential refinements to the PFS that would appropriately va lue care management within Medicare's statutory structure for fee-for-service physician payment and qu ality reporting. For example, in the CY 2013 PFS final rule with comment period, we adopted a policy to pay separately for care management involving the transition of a beneficiary from care furnished by a treating physician during a hospital stay to care furnished by the beneficiary's primary physician in the community (77 FR 68978 through 68993). We view potential refinements to the PFS such as these as pa rt of a broader strategy that relies on input and information gathered from the initia tives described above, research and demonstrations from other public and private stakeholders, the work of all parties i nvolved in the potentially misv alued code initiative, and from the public at large.

### CMS-1600-FC 591

1. Patient Eligibility for Separately Payable N on-Face-to-Face Chronic Care Management Services Under current PFS policy, the payment for non-f ace-to-face care management services is bundled into the payment for face-to-face E/M visits because care management is a component of those E/M services. The pre- and post-encounter non-face-to-face care management work is included in calculating the total work for the typical E/M services, and the to tal work for the typical service is used to develop RVUs for the E/M services. In the CY 2012 PFS propo sed rule, we highlighted some of the E/M services that include substantial care management work. Speci fically, we noted that the vignettes that describe a typical service for mid-level office/outpatient servi ces (CPT codes 99203 and 99213) include furnishing care management, communication, and other necessary care management related to the office visit in the post-service work (76 FR 42917). However, the physician community continues to tell us that the care management included in many of the E/M services, such as office visits, do es not adequately describe the typical non-face-to-face care management work involved for certain categories of beneficiaries. In addition, there has been substantial growth in medical practices that ar e organized as medical homes and devote significant resources to care management as one of the keys to improve the quality and coordination of health care

services. Practitioners in these medical homes have al so indicated that the care management included in many of the E/M services does not adequately descr ibe the typical non-face-to-face care management work that they furnish to patients. Because the current E/M office/outpatient visit CPT codes were designed to support all office visits and reflect an overall orientation toward epis odic treatment, we agree that these E/M codes may not reflect all the services and resources required to furn ish comprehensive, coordinated care management for certain categories of beneficiaries. For example, we currently pay physicians separately for the non faceto-face care plan oversight services furnished to bene ficiaries under the care of home health agencies or hospices and we currently pay separately for care management services furnished to beneficiaries transitioning from care furnished by a treating physicia n during a hospital stay to care furnished by the beneficiary's primary physician in the community.

### CMS-1600-FC 592

Similar to these situations, we believe that the resources required to furnish chronic care management services to beneficiaries with multiple (that is, two or more) chronic conditions are not adequately reflected in the existing E/M codes. Therefore, for CY 2015, we proposed to establish a separate payment under the PFS for chronic care manage ment services furnished to patients with multiple chronic conditions that are expected to last at least 12 months or until the death of the patient, and that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline. We also stated our intent to develop standards for furnishing chronic care management services to ensure that the physicians and practitioners who bill for these services have the capability to provide

them.

Comment : The vast majority of commenters overw helmingly supported the broad policy of paying separately for non-face-to-face chronic care management services, but submitted comments on many specific aspects of our proposal. Response : We appreciate the widespread support expressed by commenters for our proposed policy. We address the more specific comments below in this section.

Comment : Some commenters supported our proposed patient eligibility for chronic care management services, at least for the initial implemen tation of separate payment for the services. Typical of these comments was this statement by one commenter: “CMS should initially offer these services to patie nts with multiple chronic conditions that are expected to last at least 12 months or until the death of the patient, and that place the patient at significant risk of death, acute exacerbation/ decompensation, or functional decline.”

We also received comments indicating that th e patient eligibility should be broadened, for example, to allow eligibility for patients with one cond ition or for all patients in a practice that meets the practice standards we establish. On the other hand, some commenters believed that the eligible patient population should be narrowed. Many of these commenters indicated that the benefits of chronic care management are likely to increase with thethe patient’s acuity and risk. Many commenters indicated that the criteria described in

### CMS-1600-FC 593

the prefatory language for the complex chronic care coordination CPT codes 99487-99489 describes a narrower and more appropriate pa tient population. The CPT criteria for CY 2014 currently state:“Patients who require complex chronic care coordination services may be identified by practicespecific or other published algorithms that rec ognize multiple illnesses, multiple medication use, inability to perform activities of daily living, requirement for a caregiver, and/or repeat admissions or emergency department visits. Typical adult patients take or receive three or more prescription medications and may also be receiving other types of therapeutic interventions (eg, physical therapy, occupational therapy) and have two or more chronic continuous or episodic health conditions expected to last at least 12 m onths, or until the death of the patient, that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline. Typical pediatric patients receive three or more therapeutic interventions (eg, medications, nutritional support, respiratory therapy) and have two or more chronic continuous or episodic health conditions expected to last at least 12 m onths, or until the death of the patient, that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline. Because of the complex nature of their diseases and morbidities, these patients commonly require the coordination of a number of specialties and services. In some cases, due to inability to perform IADL/ADL and/or cognitive impairment the patient is unable to adhere to the treatment plan without substantial assistance from a caregiv er. For example, patients may have medical and psychiatric behavioral co-morbidities (eg, demen tia and chronic obstructive pulmonary disease or substance abuse and diabetes) that complicate thei r care. Social support requirements or access to care difficulties may cause a need for these services. Medical, functional, and/or psychosocial problems that require medical decision making of moderate or high complexity and extensive clinical staff support are required.”

MedPAC and other some commenters did not r ecommend specific alternative patient eligibility criteria, but stated that CMS should develop such cr iteria to better target the beneficiaries requiring significant management. One commenter recommended that the eligible patient population be narrowed to patients with four or more chronic conditions. Response : As we stated in the proposed rule, we believe that the resources required tofurnish chronic care management services to beneficiaries with two or more chronic conditions are not adequately reflected in the existing E/M codes. Furnishing care management to beneficiaries with multiple chronic conditions requires multidisciplinary care modalities that involve: regular physic ian development and/or revision of care plans; subsequent reports of patient status; review of laboratory and other studies; communication with other health professionals not employ ed in the same practice who are involved in the patient’s care; integration of new information into th e care plan; and/or adjustment of medical therapy.

### CMS-1600-FC 594

Our proposal was also supported by an analysis of Medicare claims for patients with selected multiple chronic conditions (see http://www.cms.gov/Research-Statistics-Data -and-Systems/Statistics-Trends-andReports/Chronic-Conditions/D ownloads/2012Chartbook.pdf ). This analysis indicated that patients with these selected multiple chronic conditions are at incre ased risk for hospitalizations, use of post-acute care services, and emergency department visits. We contin ue to believe these findings would hold in general for patients with multiple chronic conditions that are e xpected to last at least 12 months or until the death of the patient, and that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline. (We note that we did not propo se to limit the eligible chronic conditions to those contained in our Medicare data analysis.) We con tinue to believe that successful efforts to improve chronic care management for these patients could im prove the quality of care while simultaneously decreasing costs (for example, through reductions in hospitalizations, use of post-acute care services, and emergency department visits.) Therefore, we ag ree with the commenters who supported our proposed patient eligibility criteria. While we also agree with the commenters w ho stated that the benefits from chronic care management are likely to increase the greater the acu ity and risk to the patient, we disagree that the benefits and higher resource requirements for furnishi ng the service are limited to those even higher risk patients within the population of patients with two or more chronic conditions. Therefore, we disagree that the eligible patient population should be narrowed. We also disagree with commenters who indicated that we should immediately expand the eligible patient population, for example, to include some patie nts with a single chronic condition or all the patients in a practice that meets future standards. It is not clear at this time that the resources required to provide typical chronic care management to these patients are not reflected adequately in the existing E/M codes. However, as we indicated in the proposed rule, we have over time recognized certain categories of beneficiaries for whom we allow separate payment for care management. We have not indicated that we have exhaustively identified all such categories of bene ficiaries. We will continue to carefully consider whether there are categories of patients for whom the resources required to provide chronic care

### CMS-1600-FC 595

management services are not adequately reflected in the existing E/M codes. We may consider changes to the patient eligibility in future rulemaking. In summary, we are finalizing without modification our proposed patient eligibility for chronic care management services to be patients with multiple ch ronic conditions that are expected to last at least 12 months or until the death of the patient, and that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline. We note that although we are finalizing our pro posed eligibility criteria, since we agree with

commenters that the benefits from chronic care mana gement are likely to increase with the greater the acuity and risk to the patient, we expect that physic ians and other practitioners will particularly focus on higher acuity and higher risk patients (for example, patients with four or more chronic conditions as suggested by one commenter) when furnishing chronic care management services to eligible patients.

Comment : Many commenters found our use of the te rm “complex” to describe these services to be confusing in light of the number of Medicare be neficiaries within a practice potentially meeting our proposed eligibility criteria, and suggested that the wo rd could be interpreted to significantly narrow the appropriate patient population eligible for chronic care management services. Response : We regret any confusion generated by our proposed use of the term “complex” to describe the chronic care management services that are not adequately reflected in the existing E/M codes. Although the provision of these services is comp lex relative to the care management reflected in the existing E/M codes, we understand the confusion on the part of commenters regarding the number of patients within a practice that are potentially eligible for the service versus those that would be considered “complex.” Therefore, to reduce potential confusi on, we will revise the code description for these services to describe “chronic care management” servic es rather than complex chronic care management

services. We note that we have revised referenc es throughout this preamble to remove the word “complex” from the description of these services. 2. Scope of Chronic Care Management Services 

### We proposed that the scope of chronic care management services includes:

### CMS-1600-FC 596

● The provision of 24-hour- a-day, 7-day- a-week access to address a patient’s acute chronic care needs. To accomplish these tasks, we would expect th at the patient would be provided with a means to make timely contact with health care providers in the practice to address urgent chronic care needs regardless of the time of day or day of the week. Members of the chronic care team who are involved in the after-hours care of a patient must have access to the patient’s full electronic medical record even when the office is closed so they can continue to participate in care decisions with the patient.

● Continuity of care with a designated practitione r or member of the care team with whom the patient is able to get successive routine appointments.

● Care management for chronic conditions includi ng systematic assessment of patient’s medical, functional, and psychosocial needs; system-based appr oaches to ensure timely receipt of all recommended preventive care services; medication reconciliation with review of adherence and potential interactions; and oversight of patient self-manage ment of medications. In consulta tion with the patient and other key practitioners treating the patient, the practitioner fu rnishing chronic care management services should create a patient-centered plan of care document to assur e that care is provided in a way that is congruent with patient choices and values. A plan of care is based on a physical, mental , cognitive, psychosocial, functional and environmental (re)a ssessment and an inventory of resources and supports. It is a comprehensive plan of care for all health issues. It typically includes, but is not limited to, the following elements: problem list, expected outcome and prognosis, measurable treatment goals, symptom management, planned interventions, medication mana gement, community/social services ordered, how the services of agencies and specialists unconnected to the practice will be directed/coordinated, identify the individuals responsible for each intervention, requ irements for periodic review and, when applicable, revision, of the care plan. The provider should seek to reflect a full list of problems, medications and medication allergies in the electroni c health record to inform the car e plan, care coordination and ongoing

clinical care.

● Management of care transitions within health car e including referrals to other clinicians, visits following a patient visit to an emergency department , and visits following discharges from hospitals and

### CMS-1600-FC 597

skilled nursing facilities. The practice must be able to facilitate communication of relevant patient information through electronic exchange of a summa ry care record with other health care providers regarding these transitions. The practice must also have qualified personnel who are available to deliver transitional care services to a patient in a timely wa y so as to reduce the need for repeat visits to emergency departments and re-admissions to hospitals and skilled nursing facilities.

● Coordination with home and community based c linical service providers required to support a patient’s psychosocial needs and functional deficits. Communication to and from home and community based providers regarding these clinical patient need s must be documented in practice’s medical record system.

● Enhanced opportunities for a patient to communicate with the provider regarding their care through not only the telephone but also through the use of secure messaging, internet or other asynchronous non face-to-face consultation methods.

Comment : Some commenters supported our proposed scope of services, indicating that the requirements are consistent with what is expected in a primary care medical home. Other commenters, while generally supportive of the proposed scope of services, provided comments on specific aspects of the proposed scope. Response : We agree with the commenters who suppo rted our proposed scope of services and agree that the requirements are consistent with what is expected in a primary care medical home. We summarize and respond to comments on specific aspects of the proposed scope below.

Comment : Some commenters indicated that while th ey agreed with the goal of having members of the chronic care team who are involved in the after-hours care of a patient having access to the patient’s full EHR, that this was not currently possi ble for too many physicians who would otherwise be able to provide this service. Some commenters i ndicated that many practices will be using EHR systems that qualify for Meaningful Use Stage 2, but that do not support 24/7 remote access. Some commenters suggested that the 24/7 EHR access requirement be changed to require that members of the chronic care team have access to timely EHR information (t hat is, through the EHR or other formats.)

### CMS-1600-FC 598

Response : Given that the comments on our proposed policy to require 24/7 access to the EHR were generally part of broader comment s on the role of EHRs in the standards that must be met in order to furnish chronic care management services, we inte nd to address this issue in future rulemaking to

establish the standards. Summaries of these broade r comments can be found below in the standards

section.

Comment : Some commenters stated that it was not feasible in many practices for a patient’s personal practitioner or another clini cal team member to be available on a 24/7 basis for every patient. Other commenters recommended gradually phasing in this requirement over time. Response : The evolving medical literature on chr onic care management and patient centered medical homes emphasizes the central importance of members of the care team being available 24/7 to address a patient’s acute chronic care needs. Moreover , we believe the 24/7 availability of the care team is an important factor contributing to higher res ource costs for these services that are not currently reflected in E/M services. Therefore, we disagree wi th commenters who requested that we relax or phase in the 24/7 requirement.

Comment : Some commenters requested that we clarify the scope of services with respect to caregivers for patients with chronic care needs. So me of these commenters recommended that we require providers to address the needs of caregivers, especia lly caregivers who are Medicare beneficiaries, since caregivers are at elevated risk of health issues from emotional and physical stresses. Response : As with transitional care management ( 77 FR 68989), communication that is within the scope of services for chronic care management includes communication with the patient and caregiver. We also agree with commenters that careg ivers who are Medicare beneficiaries, as with any Medicare beneficiary, should be provided with need ed high quality, efficient care congruent with the patient’s choices and values. We note, however, that we do not have the statutory authority to extend

Medicare benefits to individuals who are not eligible for those benefits.

Comment : While the majority of commenters expr essed support for our proposal to require a patient-centered plan of care, some commenters believed that this requirement was not necessary in all

### CMS-1600-FC 599

cases. These commenters suggested th at the requirement be changed to require a plan of care document

as needed. Response : We disagree with these comments. As we indicated in the propose rule, we believe that patients with multiple chronic conditions are at increased risk for hospitalizations, use of post-acute care services, and emergency department visits. Gi ven this increased risk, we believe that a patientcentered plan of care document is a critical tool to help ensure appropriate care management for these patients. In the absence of such of document, we be lieve there would be significantly greater potential for gaps in care coordination. In addition, we recei ved many comments supporting active involvement of the patient and caregiver in chronic care management. We believe our requirement that a written or electronic copy of the patient-centered plan of care document be provided to the patient facilitates this

involvement.

Comment : Some commenters expressed concern regarding our proposal to include enhanced opportunities for a patient to communicate with the pr ovider regarding their care through not only the telephone but also through the use of secure messag ing, internet or other asynchronous non face-to-face consultation methods. They indicated that many pati ents and/or caregivers may not be capable of using this type of communication, even if the practice is equipped to provide it. Response : We disagree with these comments. Recognizing the growing use of, and patient and caregiver interest in, asynchronous communication through secure email, text and other modalities to support access to health care, we believe that it is reasonable for beneficiaries and their caregivers who would receive non-face-to-face chronic care management services to be able to communicate with the practice not only by telephone but through asynchr onous communication modalities. We note that although the expectation is for the practice to provide these communication options, there is no requirement that the practice ensure that every patient and caregiver makes use of these options.

Comment : Some commenters requested that we exp licitly require the chronic care management practitioner to consider various specific services or disease specific services when furnishing the scope of chronic care management services.

### CMS-1600-FC 600

Response : In our proposed scope of services, we stated that, “A plan of care is based on a physical, mental, cognitive, psychosocial, functional and environmental (re)asse ssment and an inventory of resources and supports. It is a comprehensive plan of care for all health issues (emphasis added).” Since the plan of care, as we described it, is to be comprehensive, we do not believe it is necessary for the scope of services to exhaustively list specific possible services that the chronic care management practitioner should consider when furnishing the scope of chronic care management services. In summary, we are finalizing the following as th e scope of chronic care management services.

● The provision of 24-hour- a-day, 7-day- a-week access to address a patient’s acute chronic care needs. To accomplish these tasks, we would expect th at the patient and caregiver would be provided with a means to make timely contact with health care provi ders in the practice to address the patient’s urgent chronic care needs regardless of the time of day or day of the week.

● Continuity of care with a designated practitione r or member of the care team with whom the patient is able to get successive routine appointments.

● Care management for chronic conditions includi ng systematic assessment of patient’s medical, functional, and psychosocial needs; system-based appr oaches to ensure timely receipt of all recommended preventive care services; medication reconciliation with review of adherence and potential interactions; and oversight of patient self-manage ment of medications. In consulta tion with the patient, caregiver, and other key practitioners treating the patient, the pr actitioner furnishing chronic care management services should create a patient-centered plan of care document to assure that care is provided in a way that is congruent with patient choices and values. A plan of care is based on a physical, mental, cognitive, psychosocial, functional and environm ental (re)assessment and an invent ory of resources and supports. It is a comprehensive plan of care for all health issues. It typically includes, but is not limited to, the following elements: problem list, expected outcome and prognosis, measurable treatment goals, symptom management, planned interventions, medication mana gement, community/social services ordered, how the services of agencies and specialists unconnected to the practice will be directed/coordinated, identify the individuals responsible for each intervention, requ irements for periodic review and, when applicable,

### CMS-1600-FC 601

revision, of the care plan. The provider should seek to reflect a full list of problems, medications and medication allergies in the electroni c health record to inform the car e plan, care coordination and ongoing

clinical care.

● Management of care transitions within health car e including referrals to other clinicians, visits following a patient visit to an emergency department , and visits following discharges from hospitals and skilled nursing facilities. The practice must be able to facilitate communication of relevant patient information through electronic exchange of a summa ry care record with other health care providers regarding these transitions. The practice must also have qualified personnel who are available to deliver transitional care services to a patient in a timely wa y so as to reduce the need for repeat visits to emergency departments and re-admissions to hospitals and skilled nursing facilities.

● Coordination with home and community based c linical service providers required to support a patient’s psychosocial needs and functional deficits. Communication to and from home and community based providers regarding these clinical patient need s must be documented in practice’s medical record system.

● Enhanced opportunities for a patient and caregiv er to communicate with the provider regarding the patient’s care through not only the telephone but also through the use of secure messaging, internet or other asynchronous non face-to-fa ce consultation methods. We also note that we continue to assess the poten tial impact of the scope of our chronic care management policy on our current programs and dem onstrations designed to im prove payment for, and encourage long-term investment in, care management services. Likewise, to assure that there are not duplicate payments for delivery of care management services, we continue to consider whether such payments are appropriate for providers partic ipating in other program s and demonstrations. 3. Standards for Furnishing Chronic Care Management Services Not all physicians and nonphysic ian practitioners who wish to furnish chronic care management services currently have the capability to fully furnish the scope of these services without making additional investments in technology, staff training, and the development and maintenance of systems and

### CMS-1600-FC 602

processes to furnish the services. We stated in the pr oposed rule that we inte nded to establish standards that would be necessary to furnish high quality, comprehensive and safe chronic care management services. We also stated that one of the primary r easons for our 2015 implementa tion date was to provide sufficient time to develop and obtain public input on the standards. Since we continue to believe that practice standards are one of the most critical com ponents of our chronic care management policy. We are developing the standards in 2014 and will implemen t them in 2015. They will be established through notice and comment rulemaking for CY 2015 PFS. In the proposed rule (78 FR 43338-43339), we solicited public comments for suggestions regarding standards for furnishing chronic care ma nagement. Although we solicited comments, we did not propose to adopt any specific standards and are, ther efore, not finalizing a policy relating to this issue in this final rule with comment period. Below are our responses to public comments received. As stated above, the public comments received for these potential standards for chronic care management are beyond the scope of the proposed rule, and therefore, the adoption of any such st andards would be addressed through separate notice-andcomment rulemaking.

Comment: Some commenters were in favor of estab lishing standards for furnishing chronic care management services, generally supporting CMS’s acknowledgement of the critical importance of managing care for these Medicare beneficiaries with ch ronic conditions. Commenters also believe that care coordination is an integral part of improving patient care. Many commenters expressed concerns and did not support establishing standards for furnishing chronic care management services as we discussed in the proposed rule (78 FR 43338-43339). Some commenters stated the standards we suggested we re too aggressive, needed clarification and/or refinement, and were overly burdensome citing that a doption should be delayed, perhaps for years or indefinitely. Commenters suggested that practice capabilities as outlined could exclude many physicians from furnishing these services, despite the physicians be ing specially trained in chronic care management and having demonstrated the ability to furnish signi ficant quality of care. Many commenters suggested

### CMS-1600-FC 603

that CMS partner (through an advisory group, wor kgroups, etc.) with interested stakeholders, obtain public input, and work with the CMS Innovation Cent er to continue developing and refining more reasonable potential future standards for furnishing ch ronic care management in order to ensure that the physicians who bill for these services have the cap abilities to furnish them. Some commenters suggested integration of chronic care management standards with the State laws governing the practice of medicine. Commenters also urged CMS not to impose requirement s that would preclude specialists from furnishing

these critical services. Response: We appreciate commenters’ suggestions and will consider these comments for any future rulemaking on this topic. As discussed in the proposed rule, potential st andards (78 FR 43338-43339) could include the following:

● The practice must be using a certified Electronic Health Record (EHR) for beneficiary care that meets the most recent HHS regulatory standard for meaningful use. The EHR must be integrated into the practice to support access to care, care coor dination, care management, and communication.

Comment: Commenters generally supported the value of EHRs in regard to the capabilities to enhance the quality of care for chronic care manageme nt. Commenters requested that CMS clarify the following issues if CMS were to move forward with meaningful use as a standard for chronic care management: how a provider new to Medicare or ne w to a practice would be treated, and how a provider would be treated who formerly met meaningful use but failed to do so in a subsequent year (specifically, whether the practice would be required to repay the chronic care management payment, and whether the practice would have to stop providing these services to beneficiaries in the future). Other commenters noted that while EHRs may facilitate documentati on, they are being replaced by “cloud-based” data repositories for beneficiary medical records and social media is being used for communication solutions. Many commenters did not support requiring the pr actice to use a certified EHR, some questioning whether an EHR is really essential to providing these services. These commenters discouraged CMS from including meaningful use as a standard for chroni c care management, noting that it is premature to

### CMS-1600-FC 604

link these services to meaningful use, and that requiring meaningful use as a standard should be delayed until the meaningful use policy has been stabilized and more practices have achieved it. Commenters generally expressed concern regarding linking the prov ision of chronic care management to meaningful use as practices would have to delay furnishing care management for a full year until they have met meaningful use, denying their patients the benefit of those services. Commenters urged CMS not to require a specific stage of meaningful use certif ication. Commenters urged elimination of this requirement noting it interfered with the physician’ s prerogatives and practice; and suggesting that it has nothing to do with how effectiv ely a physician manages patients with chronic conditions. Some commenters suggested that the notio n that there should be immediate online access to every patient’s complete EHR is unrealistic for many practices (that is, internet access issues, 24/7 availability of the full EHR, on-call health professional being from a different practice and not having access, etc.), particularly those who would most benefit from the potential chro nic care management reimbursement. Commenters also noted EHR interoperability is not yet attainable by the vast majority of phy sicians across the country. Many commenters suggested CMS consider flexibilit y (that is, a phased-in approach) in requiring EHRs to avoid excluding otherwise qualified practices in ar eas of need. Some commenters noted that phasing in EHR requirements would aid those smaller practices, or rural areas, that do not currently utilize EHRs and

thus would not be able to be reimbursed for furn ishing beneficiaries with chronic care management services. Other commenters expressed concern that this requirement could pose a problem for small practices (that is, economically depressed, medically underserved, etc.) for which the expense of obtaining and implementing EHR systems could be pr ohibitive despite the fact they could meet the remainder of the requirements for chronic care manage ment. Commenters raised concerns that language in the preamble suggests that all practitioners particip ating in the care of a beneficiary receiving chronic care management services would need to be able to share information related to the care plan electronically, and that it would be very difficult to meet this requirement as not all practices have access

to electronic means of communication.

### CMS-1600-FC 605

Response: We appreciate commenters’ suggestions and will consider these comments for any future rulemaking on this topic.

● The practice must employ one or more advanced practice registered nurses or physicians assistants whose written job descriptions indicate that their job roles include and are appropriately scaled to meet the needs for beneficiaries receiving services in the practice who require chronic care management services furnished by the practice.

Comment: Some commenters supported the requirement to employ non-physician professionals, and encouraged CMS to expand this list to incl ude registered nurses, pharmacists (particularly hematology/oncology clinical specia list pharmacists), social workers, Emergency Department physicians, “caregivers” (that is, those that help with Alzh eimer’s disease and dementia patients), “direct-care worker,” and other specialists such as hematologists, cardiologists, and nephrologists. Some commenters sought clarification regarding whether advanced practice nurse practitioners and physician assistants would have to be available 24/7, a nd what type of chronic care management services they must furnish. Many commenters, however, were not in support of the requirement that advanced practice nurses or physician assistants must be employed by the medical practice. Commenters urged elimination of this requirement noting that it interfered with the physician’s prerogatives; indicating that this staffing requirement would have little, if an ything, to do with how effectively a physician manages patients with chronic conditions, and suggesting that it could be co nsidered cost prohibitive. Some commenters urged CMS to relax this requirement and recognize that these services could be effectively performed by appropriately trained, licensed, and, when appli cable, credentialed clinical staff. Commenters recommended that CMS not prescribe the hiring decisions for practices to be eligible to furnish chronic care management services. Commenters suggested th at the agency instead should provide greater flexibility for practices to demonstrate that they have the structural capabilities, personnel, and systems to coordinate care effectively, through their own enga gement with patients, as well as by having other qualified health care professionals available, either within the practice itself or through external arrangements to furnish chronic care management services.

### CMS-1600-FC 606

Some commenters suggested that, under certain ci rcumstances independently contracted (but not necessarily employed) personnel could participate in furnishing these services under the general supervision of a physician or non- physician practitioner, and sought clarification on whether “employ” could include “contract” personnel. Other commenter s requested that the standards recognize that nurses can perform this work under the direction and superv ision of physicians, especially since many practices employ registered nurses who are well qualified to provide care coordination. Some commenters believed that this requirement was particularly ill-a dvised and inappropriate, and strongly disagreed that employment of this level of staff should be a consideration in furnishing these services. Other commenters noted that this requirement would deter small and rural practices from offering chronic care management services. Commenters supported care teams/ team-based care, but indicated that a practice

should have the discretion to hire and develop those care teams, and not be required specifically to hire advanced practice nurse practitioners or physician assi stants. Some commenter s suggested that a “care manager” concept could be used, wh ich could be a registered nurse, social worker, advanced practice nurse or physician assistant who has received training to perform the service. Commenters also suggested that CMS revise the requirement regarding who must em ploy the care manager to also allow the practice, or physician organization on the prac tice’s behalf, to be the employer. Response: We appreciate commenters’ suggestions and will consider these comments for any future rulemaking on this topic.

● The practice must be able to demonstrate the use of written protocols by staff participating in the furnishing of services that describe: (1) the methods and expected “norms” for furnishing each component of chronic care management services furn ished by the practice; (2) the strategies for systematically furnishing health risk assessments to identify all beneficiaries eligible and who may be willing to participate in the chronic care management services; (3) the procedures for informing eligible beneficiaries about chronic care management service s and obtaining their consent; (4) the steps for monitoring the medical, functional and social needs of all beneficiaries receiving chronic care management services; (5) system based approaches to ensure timely furnishing of all recommended

### CMS-1600-FC 607

preventive care services to beneficiaries; (6) guidelines for communicating common and anticipated clinical and non-clinical issues to beneficiaries; (7) care plans for beneficiaries post-discharge from an emergency department or other in stitutional health care setting, to assist beneficiaries with follow up visits with clinical and other suppliers or providers , and in managing any changes in their medications; (8) a systematic approach to communicate and electroni cally exchange clinical information with and coordinate care among all service providers involved in the ongoing care of a beneficiary receiving chronic care management services; (9) a systematic a pproach for linking the practice and a beneficiary receiving chronic care management services with long-term services and supports including home and community-based services; (10) a systematic approach to the care management of vulnerable beneficiary populations such as racial and ethnic minorities and peopl e with disabilities; and (11) patient education to assist the beneficiary to self-manage a chronic condition that is considered at least one of his/her chronic conditions. These protocols must be reviewed and upd ated as is appropriate based on the best available clinical information at least annually.

Comment: Some commenters expressed support for the outlined written protocols. A few commenters suggested that CMS develop educational mate rials to be made available to patients so they better understand these services. Commenters suggested the 11 th written protocol be revised (to be more interactive) to read “provide written protocols that describe collaborative problem solving/decision making that supports the patient in self-managing th eir chronic health conditions.” Other commenters believe that physicians and othe r providers who care for chronically ill patients can be better supported with evidence-based guidelines, specialty expertise, and information systems; such as, providers encouraging patients (through partnerships with commun ity organizations, etc.) to participate in medical systems like peer support groups, exercise programs, nurse educators, or dieticians. Commenters urged CMS to revise this requirement to provide more flexibility for practices to demonstrate they have their own protocols to ensu re that patients with chronic diseases have timely access to physicians and other team members within a realistic timeframe (that is, practices could be required to demonstrate that their patients have access the same or next day by phone, email,

### CMS-1600-FC 608

telemedicine, or in person). Other commenters s uggested CMS give more consideration to therapy services, medication management, discharge planning , care coordination, and caregiver education. Commenters also asked CMS to clarify that th e practice reporting these chronic care management services does not have to perform all care management itself, and that other practices or healthcare professionals can perform some services in coordi nation with the reporting practice. Commenters conveyed individuals with Alzheimer’s and dementias ma y not be able to participate in the development of a care plan in the same capacity as individuals who are not cognitively impaired. Some commenters requested CMS go a step further in noting the importa nce of coordination with direct-care workers and family caregivers, and requiring that this communication be documented as well. Response: We appreciate commenters’ suggestions and will consider these comments for any future rulemaking on this topic.

● All practitioners, including advanced practi ce registered nurses or physicians assistants, involved in the furnishing of chronic care management services must have access at the time of service to the beneficiary's EHR that includes all of the elemen ts necessary to meet the most recent HHS regulatory standard for meaningful use. This includes any and a ll clinical staff furnishing after hours care to ensure that the chronic care management services are availabl e with this level of EHR support in the practice or remotely through a Virtual Private Network (VPN), a secure website, or a health information exchange (HIE) 24 hours per day and 7 days a week.

Comment: Commenters were generally in support of the concept that 24/7 access to the beneficiary’s EHR would be a trem endous enhancement to furnishing chronic care management. Some commenters noted that many physicians practice in more than one setting, which can make it more challenging for them to furnish all beneficiaries w ith 24/7 EHR support to providers and care staff. Commenters noted that many of their members do not have the resources to evaluate patients 24/7; therefore, commenters urged CMS to clarify the 24/7 support can be furnished by members of the chronic care team by phone, or allow more flexibility in this requirement until the agen cy can assess the impact it may have on beneficiary access to chronic care management services. Some commenters noted that many

### CMS-1600-FC 609

physicians can access their own organization’s EHR bot h in and outside typical business hours, but do not currently have “real-time” access to all of the EHR da ta for beneficiaries under their care, especially if they are moving provider settings. Response: We appreciate commenters’ suggestions and will consider these suggestions for any future rulemaking. Some have suggested that, to furnish these servi ces, practices could be recognized as a medical home by one of the national organizations (incl uding the National Committee for Quality Assurance (NCQA), the Accreditation Association for Ambulat ory Health Care, The Joint Commission, URAC, etc.), which are formally recognizing primary care practices as a patient-centered medical home. We understand there are differences among the approaches ta ken by national organizations that formally recognize medical homes and therefore, we so licited comment on these and other potential care coordination standards, and the potential for CMS recognizing a formal patient-centered medical home designation as one means for a practice to demonstrate it has met any final care coordination standards for furnishing chronic care management services.

Comment: Some commenters supported recognizing a patient centered medical home model to

meet the care coordination standards. Commenter s recommended that CMS allow for multiple pathways for accreditation recognition, and/or certification of patient centered medical homes and patient centered medical home neighborhood practices, noting other en tities offer these programs, such as URAC and The Joint Commission. Some commenters supported th e specialty practice recognition program, under NCQA, to be included to enable specialists to be ab le to participate. Commenters also suggested that CMS include other approaches to recognize medical homes as developed by private health plans and within CMS via its Innovation Center Comprehensive Primary Care Initiative, some of which may not have been formally certified by an accreditation entit y. Commenters noted medical homes would be good candidates to provide chronic care management, but Patient Centered Medical Homes represent a relatively small percentage of me dical groups across the country.

### CMS-1600-FC 610

Other commenters noted they do not support a requirement that physician practices be certified as a primary care medical home to receive payment for chronic care management. Other commenters urged elimination of this requirement, noting it is t oo burdensome and would disqualify many practices furnishing these care coordination services. Commenters believe that in general, medical societies have been reluctant to accept proposals that would require medical homes or patient-centered practices to obtain accreditation/recognition by external entities; and therefore, urged CMS to work with the medical community to develop an alternative to accreditation as a path for furnishing chronic care management services. Other commenters noted this approach ig nores the fact that many patients—especially the poor—do not have a primary care provider and by defa ult, may receive substantial services from the Emergency Department, especially when other sources of primary care are unavailable or inaccessible. Some commenters conveyed that many standards fo r accreditation as a patient centered medical home do

not consider the needs of those with dementia ; adding, accreditation bodies should include quality

measures on dementia care as a standard for accred itation. Some commenters encouraged CMS to consider using QIOs to help determine if a pr ovider is meeting the requirements for chronic care management, instead of relying on a formal recognition program. Some commenters noted that, instead of requiring any particular certification or designation, any physician practice should be able to qualify for pa yment of chronic care management services as long as the individual practice meets the practice requirements established to report these individual codes. Other commenters recommended that CMS instead require pr actices to have certain capabilities (that is, 24/7 access to care, 24/7 access to the indivi dual’s medical record, those involved with the care of a patient are identified and accessible, the health risk assessment data be addressed in the care of the patient, etc.); moreover, commenters suggested that CMS should clearly articulate that the ultimate goal is for primary care practices to achieve patient-centered medical ho me certification by a certain date (for instance 2019) as this would satisfy the agency’s intention with out being overly restrictive. Commenters also recommended that if CMS decides to recogni ze certified medical homes—through accreditation organizations or otherwise—the certification standard s should fully reflect the Joint Principles for the

### CMS-1600-FC 611

Patient-Centered Medical Home ( http://tinyurl.com/ccbhvzz ). Some commenters noted that requiring practice certification, such as that offered by NCQA for Patient-Centered Medical Homes, will undoubtedly limit access to chronic care management ser vices for many beneficiaries, especially those in smaller practices and rural areas; and recommended CM S not make additional voluntary certifications mandatory, but rather look to those voluntary st andards as it collaborates with the medical professional community to develop robust standards for chroni c care management. Other commenters urged CMS to consider allowing practices to self-attest that they meet the protocol. Some commenters believe there needs to be an accountability me chanism for chronic care management which goes beyond “standards,” such as quality measures that demonstrate improved outcomes and benefits for relevant patients. Response: We appreciate commenters’ suggestions and will consider these comments for any future rulemaking on this topic. 4. Billing for Separately Payable Chronic Care Management Services To recognize the additional resources required to provide chronic care management services to patients with multiple chronic conditions, we proposed to create two new separately payable alphanumeric G-codes. Complex chronic care management services furnishe d to patients with multiple (two or more) complex chronic conditions expected to last at least 12 months, or until the death of the patient, that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline; GXXX1, initial services; one or more hours; initial 90 days GXXX2, subsequent services; one or more hours; subsequent 90 days Typically, we would expect the one or more hours of services to be provided by clinical staff directed by a physician or other qualified health care professional. 

### We also proposed that billing for subse quent chronic care management services (GXXX2) would be limited to those 90-day period s in which the medical needs of the patient require substantial revisi on of the care plan.

### CMS-1600-FC 612

We proposed that the resources required to furnish care management services for patients that do not have multiple chronic conditions would continue to be reflected in the payment for face-to-face E/M services. We also proposed th at the resources required to furnish care management services consisting of less than one or more hours of clin ical staff time over a 90- day period, and for patients residing in facility settings, would con tinue to be reflected in the payment for face-to-f ace E/M visits. We proposed that chronic care management services would include transitional care management services (CPT 99495, 99496), home h ealth care supervision (HCPCS G0181), and hospice care supervision (HCPCS G0182). If furnished, to avoid duplicate payment, we proposed that these services may not be billed separately during the 90 days for which either

GXXX1 or GXXX2 are billed. For similar reasons, we proposed that GXXX1 or GXXX2 cannot be billed separately if ESRD servic es (CPT 90951-90970) are billed during the same 90 days. We proposed to pay only one claim for chroni c care management services billed per beneficiary at the conclusi on of each 90-day period. We proposed that all of our proposed chronic ca re management services that are relevant to the patient must be furnished to bill for a 90-day period. If a face-to-face visit is provided during th e 90-day period by the practitioner who is furnishing chronic care management services, we proposed that the practitioner should report the appropriate evaluation and manageme nt code in addition to billing for chronic care management. We note that to bill for these services, we proposed that at least 60 minutes of chronic care management services must be provided during a 90-day period. Time of less than 60 minutes over the 90 day period could not be rounded up to 60 minutes to bill for these services.

### CMS-1600-FC 613

We also proposed that for purposes of meeti ng the 60-minute requirement, the practitioner could count the time of only one clinical staff member for a particular segment of time, and could not count overlapping intervals such as when two or more clinical staff me mbers are meeting about the patient.

Comment : Many commenters requested that we either adopt the current CPT codes (CPT 99487-99489) for complex chronic care coordi nation services or work with the AMA to

revise the current CPT codes rather than establis h G-codes. Commenters also requested that we shorten the billing period from 90 days to 30 da ys, monthly, or weekly out of concern that it would be administratively burdensome for some pr actices to keep track of the amount of time they had furnished the service over a 90-day peri od. Many commenters also encouraged us to reconsider the need for separate G-codes for the initial delivery of chronic care management services versus subsequent delivery of these services since these commenters indicated that the



### resource use is similar. Some commenters supported our proposal that if a face-to-face visit is provided during the period by th e practitioner who is furnishing chronic care management services, the practitioner should re port the appropriate E/M code in addition to billing for chronic care management. Some commenters requested that we consider creating codes for chronic care management services to reflect di fferent patient severity levels or create an add-on code, similar

to the current CPT add-on code for 30 minutes of additional time (CPT 99489), that recognizes additional time for more complex patients w ithin the eligib le patient population. Some commenters agreed with our proposal that time less than the time specified in the code (60 minutes in our proposal) could not be rounded up to bill for thes e services. Some commenters also requested that we provide more deta iled billing information for the services.

### CMS-1600-FC 614

Response : Regarding the suggestion to work with CPT to avoid the need to establish Gcodes, since we expect to implement paymen t for chronic care management services in 2015, there is time for CPT to establish a billing code that sufficiently reflect s our policy. We would consider using such a new or revised code. The current CPT codes do not meet our policy requirements (for example, the eligible pati ent population, the time required for the code); therefore, we are not adopting th ese codes in this final rule. We agree with commenters who suggested that we shorten the billing period for chronic care management services from 90 days to 30 days to reduce the administrative timekeeping burden on practices. We believe that a weekly bil ling interval would increa se the administrative billing burden and note that very few commenters supported this option relative to 30 day or monthly billing. We also agree with commenters that the re sources required to fu rnish the initial and subsequent services are not sufficiently different to require the establishment of separate codes to distinguish initial and su bsequent services. In response to commenters’ concerns, we ar e adopting a 30-day b illing interval for chronic care management services. Given the sh orter 30-day period, we are establishing a billing code that corresponds to 20 minutes of service during the 30-day period. Similar to our proposal, at least 20 minutes of chronic care management services must be pr ovided during the 30-day billing interval. Time of less than 20 minutes over the 30-day period co uld not be rounded up to 20 minutes to bill for these services. For purposes of meeting the 20-minute requirement, the practitioner could count the time of only one clinical staff memb er for a particular segment of time, and could not count overlapping intervals such as when two or more clinical staff members are meeting about the patient.

### CMS-1600-FC 615

With respect to comments requesting that we consider creating billing codes for chronic care management services to reflect different patient severity levels or create an add-on code that recognizes additional time for more severe patients within the eligible patient population, we are not adopting such a coding structure at this ti me. As recognized by the vast majority of commenters, paying separately for non-face-to-face chronic care management services is a significant policy change. As we gain more experience with separate payment for this service, we may consider additional changes in th e coding structure in future rulemaking. In response to comments asking that we provi de more detailed billing information for these services, we intend to provide guidan ce to our contractors and make any necessary

revisions to the relevant manua l provisions to implement the chronic care management policy. In summary, to recognize the additional resources required to provide chronic care management services to patients with multiple chronic conditions, we will be creating one new separately payable alphanume ric G-code for CY 2015. GXXX1 Chronic care management services furnished to patients with multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline; 20 minutes or more; per 30 days

Typically, we would expect th at the 20 minutes or more of chronic care management services to be provided by clin ical staff directed by a physicia n or other qualified health care professional. At least 20 minutes of chronic care manageme nt services must be provided during the 30- day period. Time of less than 20 minutes ove r the 30-day period may not be rounded up to 20

minutes in order to bill for these services. For purposes of meeting the 20-minute requirement, the practitioner could count the time of only one clinical staff member for a particular segment of

### CMS-1600-FC 616

time, and could not count overlapping intervals such as when two or more clinical staff members are meeting about the patient. We would consider using a revised CPT code that meets our policy requirements instead of creating a new G-code.

Comment : Some commenters stated that lim iting the use of the billing code for subsequent delivery of chronic ca re management services to t hose circumstances in which the beneficiary requires “subst antial revision of the care plan” und ervalues the work the practitioner and practice care team does in furnishing ongoing assistance to be neficiaries in monitoring and implementing their care plans. Some commenters i ndicated that this rest riction would reduce the potential benefits of chronic care management to the patient since in the absence of separate payment the services might be provided too intermittently. Other commenters, however, supported the restriction to tim e periods when the care plan has undergone significant revision since they believed that separately billable chronic care management should be for intense services delivered over a short pe riod of time. Generally, these commenters were also ones who also favored narrowing the eligible patient population. Response : As we stated in the discussion of the eligible patient population, we believe the resources required to furnish chronic care manage ment services to beneficiaries with two or

more chronic conditions are not ad equately reflected in the existi ng E/M codes. We agree with commenters who argued that these resources could potentially be required during periods of time when the care plan is not under going substantial revision. Therefore, after considering all the comm ents received, we are revising our proposed policy to specify that the chronic care management service may be billed for periods in which the

### CMS-1600-FC 617

medical needs of the patient requi re establishing, implementing, re vising, or monitoring the care plan, assuming all other billing requirements are met.

Comment : Some commenters objected to our pr oposal that chronic care management services include transitional care manageme nt services (CPT 99495, 99496), home health care supervision (HCPCS G0181), and hospice care supervision (HCP CS G0182) and that these services cannot be billed separa tely during the time period when the chronic care management

services are billed. Some commenters also objected to our proposal that chronic care management services cannot be billed separate ly if certain ESRD services (CPT 90951-90970) are billed during the same time period. Some commenters believed that there was insufficient overlap between the resources required to perfor m these services and chronic care management to justify restricting the billing in the manner we propose d. Other commenters indicated that more than one practitioner should be allowed to bill for chronic care management services for the same time period. Response : Given that, in response to comments, we have modified our new separately payable alphanumeric G-code for chronic care management services to describe services furnished for 20 minutes or more over a 30-day pe riod, it may not always be the case that the additional resources required to provide chronic care management services to beneficiaries with multiple chronic conditions are the same as the additional resources required provide transitional care management services (CPT 99495, 99496), home health care superv ision (HCPCS G0181), hospice care supervision (HCPCS G0182), or certain ESRD services (CPT 90951-90970). Nevertheless, given that care management is an inte gral part of all of th ese services, we believe there is significant overlap, and that paying separa tely both for chronic care management and the care management included in these services would result in duplicate payment for the

### CMS-1600-FC 618

overlapping care management. Similarly, allowi ng multiple practitioners to bill for GXXX1 during a particular billing interval would re sult in duplicate payment for overlapping care management. Therefore, we are finalizing our policy that GXXX1 and any of CPT 99495-99496, HCPCS G0181-G0182, or CPT 90951-90970 cannot be billed during the sa me 30-day period; nor can GXXX1 be billed by multiple practitioners for the same time period.

Comment : Some commenters objected to our pr oposal that the resources required to provide care management services to patients residing in facili ty settings continues to be reflected in the payment for face-to-face E/M visi ts. Commenters believed there was insufficient overlap between the scope of these care management services and the care management services provided by facilities to jus tify restricting the billing in the manner we proposed. Response : We disagree with these comments. The resources required to provide care management services to patients residing in faci lity settings significan tly overlaps with care management activities by facility staff that is incl uded in the associated facility payment. We are finalizing this part of our pr oposal without modification.

Comment : MedPAC recommended that practitione rs employed or furnishing services under arrangement with hospice or home health agenci es should not be eligible to bill for these chronic care management services, citing the Medicare claims processing manual requirements for care plan oversight services. Response : There is a requirement in the Medicare Claims Processing Manual (see http://www.cms.gov/Regulations-and-Guidanc e/Guidance/Manuals/Downloads/clm104c12.pdf ) 

### for hospice care plan oversight (CPO) that states: “The attending physician or nurse practitioner (who has been designate d as the attending physician) may bill for hospice CPO when they are acting as an ‘attending physician.’ An

### CMS-1600-FC 619

‘attending physician’ is one who has been identif ied by the individual, at the time he/she elects hospice coverage, as having the most significant ro le in the determinatio n and delivery of their medical care. They are not employed nor paid by the hospice.” We will consider MedPAC’s comment further, but are not adopting this suggestion at the current time. We note that, as stated earlier in this section, home health care supervision (HCPCS G0181) and hospice care supervision (HCPCS G0182) cannot be billed separately during the time period when the chronic care management services are billed.

Comment : Many commenters requested that we cl arify that billing for chronic care management is not restricted to primary care physi cians and that specialist physicians can bill for these services if they meet the requirements. Some non-physi cian practitioners similarly requested confirmation that they can bill for thes e services if they meet the requirements. Response : We appreciate these comments and take this opportunity to confirm that, while we expect the chronic care management code to be billed most frequently by primary care physicians, specialists who meet the requirement s may also bill for these services. As for nonphysician qualified health care prof essionals, we believe only NP s, PAs, CNSs, and certified nurse midwives (CNMs) can furnis h the full range of these services under their Medicare benefit, and only to the extent permitted by applicable limits on their state scope of practice. We believe other nonphysician practitioners (suc h as registered dieticians, nutri tion professionals or clinical social workers) or limited-license practitioners, (such as optometri sts, podiatrists, doctors of dental surgery or dental medicine), would be limited by the sc ope of their state licensing or their statutory Medicare benefit to furn ish the complete scope of these services such that they would not be able to furnish chronic care management services; and there is no Medicare benefit

### CMS-1600-FC 620

category that allows payment under the PFS to some of the other health professionals (such as pharmacists and care coordinators) mentioned by commenters. We also note that given our longstanding restriction on the use of E/M codes by clinical psychologists and the fact that payment for these chronic care management services is currently included in the payment for E/M services, clinical psychologists are also not permitted to bill for these services. However, similar to transiti onal care management, we expect practitioners furnishing chronic care management services to re fer patients to psychologists and other mental health professionals as part of chronic care management when doing so is warranted by an evaluation of the patient’s psychosocial needs. 5. Obtaining Agreement from the Beneficiary We stated in the proposed rule that not all pa tients who are eligible for separately payable chronic care management services may necessa rily want these services to be provided

. Therefore, before the practitioner can furnish or bill for these services , we proposed that the eligible beneficiary must be informed about the av ailability of the servic es from the practitioner and provide his or her consent, or synonymously in this context “agreement,” to have the services provided, including the electronic communi cation of the patient’s information with other treating providers as part of care coordination. This would include a disc ussion with the patient about what chronic care management services are, how these services are accessed, how their information will be shared among other providers in the care team, and that cost-sharing applies to these services even when they are not delivere d face-to-face in the practice. To bill for the services, the practitioner would be required to document in th e patient’s medical record that all of the chronic care management services were ex plained and offered to the patient, noting the patient’s decision to accept these services. Als o, a written or electronic copy of the care plan

### CMS-1600-FC 621

would be provided to the beneficiary and this would also be recorded in the beneficiary’s

electronic medical record. We proposed that a practitioner would need to reaffirm with the bene ficiary at least every

12 months whether he or she wishes to continue to receive chronic care management services during the following 12-month period. We proposed that the agreement for chronic care management servi ces could be revoked by the beneficiary at any time. However, if th e revocation occurs during a current chronic care management period, the revocation would not be effective until the end of that period. The beneficiary could notify the practi tioner either verbally or in wr iting. At the time the agreement is obtained, the practitioner would be required to inform the benefi ciary of the right to stop the chronic care management services at any time and the effect of a revocation of the agreement on chronic care management services. Revocation by the beneficiary of the agreement must also be noted by recording the date of the revocation in the beneficiary’s medical record and by providing the beneficiary with wr itten confirmation that the pract itioner would not be providing chronic care management serv ices beyond the current period. We proposed that a beneficiary who has revoked the agreement for chronic care management services from one practitioner may c hoose instead to receive these services from a different practitioner, which can begin at th e conclusion of the current period. The new practitioner would need to fulfill all th e requirements for billing these services. We proposed that prior to submitting a claim for chronic care management services, the practitioner must notify the beneficiary that a claim for these services will be submitted to

Medicare. The notification must i ndicate: that the beneficiary ha s been receiving these services over the previous period (noti ng the beginning and end dates for the period); the reason(s) why

### CMS-1600-FC 622

the services were provided; a nd a description of the services provided. The notice may be delivered by a means of communication mutually agreed to by the practitioner and beneficiary such as mail, email, or facsimile, or in person (forexample, at the time of an office visit). The notice must be received by the beneficiary befo re the practitioner submits the claim for the services. A separate notice must be received by the beneficiary for each period for which the services will be billed. A copy of the notice should be included in the medical record.

Comment : While most commenters endorsed the ge neral concept that that there should be a process whereby a practitione r would obtain agreement from an eligible beneficiary for the delivery of the service, we received co mments on specific aspects of our proposal. Some commenters supported our beneficiary agreement policies as proposed. Other commenters believed that notifyi ng the beneficiary would be su fficient and that a formal agreement should not be required. Some commente rs raised concern about the burden of having to obtain an annual agreement rath er than obtaining just one agr eement at the outset of furnishing the services. Many commenters recommende d that CMS remove the requirement that practitioners notify beneficiaries in writing pr ior to each billing for chronic care management services, while other commenters supported this requirement. The commenters opposed to the pre-billing notification requirement viewed this as administratively burdensome and unnecessary given the informed agreement process for this service. Some commenters indicated that beneficiary agreement would be much easier to obtain if the service were not subject to coinsurance. Many commenters requested that we prov ide beneficiary education on this issue. Response : We appreciate commenters recognizing th e value of our requiring practitioners to inform beneficiaries about their eligibility to receive chronic care management services. We note that we 

### do not have the statutory authority to waiv e the cost-sharing for these services. Since

beneficiaries who receive these services will be bi lled for cost-sharing, we believe it is prudent to

### CMS-1600-FC 623

require their written agreement prior to initia ting the service. We agree that to reduce administrative burden, the informed agreement pro cess need only occur once at the outset of furnishing the service, rather than annually as we had proposed, and that it only needs to be repeated if the beneficiary opts to change the practitioner who is de livering the services. We also agree with commenters who suggested that we relax the requirement that a practice inform a beneficiary prior to each time a bill is submitted. While we believe that this approach could reduce any potential confusion around cost-shari ng charges, we agree that practitioners can

address this in the inform ed agreement process. In response to comments recommending that we educate beneficiaries about chronic care management services, we note that we provide extensive beneficiar y education regarding Medicare benefits, including Medicare and Y ou and other publicati ons, Medicare.gov, and 1-

800-MEDICARE. We will include information c oncerning chronic care management in our

outreach efforts. The final beneficiary agreement requirements for CY 2015 are as follows. Before the practitioner can furnish or bill fo r these services, the el igible beneficiary must be informed about the availability of the services from the practit ioner and provide his or her written agreement to have the services provided, including agreeing to the electronic communi cation of the patient’s information with other treating providers as pa rt of care coordination. This would include a discussion with the patient, and caregiver when applicable, about what chronic care management services are, how these services are accessed, how the patient’s information will be shared among other providers in the care team, and that co st-sharing applies to these services even when they are not delivered face-to-face in the practice. To bill for the services, the practitioner would be required to document in the patient’s medical r ecord that all of the chronic care management

### CMS-1600-FC 624

services were explained and offered to the patien t, noting the patient’s de cision to accept these services. Also, a written or electronic copy of the care plan is required to be provided to the beneficiary, and the provision of th e plan to the patient must also be recorded in the beneficiary’s

electronic medical record. The agreement for chronic care management services could be revoked by the beneficiary at any time. However, if the revocation occurs during a current chronic care management 30-day period, the revocation is not effective until the end of th at period. The beneficiary could notify the practitioner of revocation either verbally or in wr iting. At the time the agreement is obtained, the practitioner is required to inform the beneficiary of th e right to stop the chronic care management services at any time (effective at the end of a 30-day period ) and the effect of a revocation of the agreement on chronic care management services. The practitioner is also required to inform the beneficiary that only one practitioner is able to be separately paid for these services during the 30-day period. Revocation by the beneficiary of the agreement must also be noted by recording the date of the revocation in the beneficiary’s medical record and by providing th e beneficiary with written confirmation that the practitioner would not be providing chronic care mana gement services beyond the current 30-day period. A beneficiary who has revoked the agreement for chronic care management services from one practitioner may choose instead to receive these services from a different practitioner, which can begin at the conclusion of the current 30-day period. If a beneficiary chooses to receive these services from a different practitioner, the beneficiar y should revoke the agreement with the current practitioner. The new practitioner would need to fulfill all the requirements for billing these services. 5. Chronic Care Management Services and the Annual Wellness Visit (AWV) (HCPCS codes G0438, G0439) 

### We proposed that a beneficiary must have rece ived an AWV in the past 12 months for a practitioner to be able to bill separately for ch ronic care management services. We believe that the linking of these services to the AWV makes se nse for several reasons. First, the AWV is

### CMS-1600-FC 625

designed to enable a practitioner to systematically capture information that is essential for the development of a care plan. This includes the esta blishment of a list of current practitioners and suppliers that are regularly i nvolved in providing medical care to the beneficiary, the assessment of the beneficiary’s functional status related to chronic hea lth conditions, the assessment of whether the beneficiary suffers from any cognitive limitations or mental health conditions that could impair self-management of chronic he alth conditions, and an assessment of the beneficiary’s preventive health care needs incl uding those that contribut e to or result from a beneficiary’s chronic conditions. Second, the beneficiary’s selecti on of a practitioner to furnish

the AWV is a useful additional indicator to assist us in know ing which single practitioner a beneficiary has chosen to furnish chronic care management services. Although a beneficiary would retain the right to choose and change the practitioner to fu rnish chronic care management services, we do not believe that it is in the inte rest of a beneficiary to have more than one practitioner at a time coordinating the benefici ary’s care and we do not intend to pay multiple practitioners for furnishing thes e services over the same time pe riod. Third, the AWV is updated annually which is consistent with the minimal in terval for reviewing and modifying the care plan required for the chronic care management services. We would expect that the pr actitioner the beneficiary choos es for the AWV would be the practitioner furnishing the chronic care management services. For the less frequent situations when a beneficiary chooses a different practi tioner to furnish the chronic care management services from the practitioner who in the previous year furn ished the AWV, the practitioner furnishing the chronic are management services would need to obtain a copy of the assessment and care plan developed between the beneficiary and the prac titioner who furnished the AWV prior to billing for chronic care management services.

### CMS-1600-FC 626

Because a beneficiary is precluded from r eceiving an AWV within 12 months after the

effective date of his or her first Medicare Pa rt B coverage period, for that time period we proposed the Initial Preventive Physical Exam ination (G0402) can substitute for the AWV to allow a beneficiary to receive ch ronic care management services.

Comment : Although some commenters supported our proposal, there were numerous comments recommending that we remove the requi rement for an Annual Wellness Visit prior to a practitioner being able to furnish chronic care management services. While some commenters acknowledged that the Annual Welln ess visit could provide valuable information for establishing a care plan and for ensuring that only one prac titioner billed for the ch ronic care management services, many expressed concern that this could present a significant barrier to otherwise eligible beneficiaries receiving the services. Response : We believe that both the practitioner and the beneficiary would benefit if an AWV or an Initial Preventive Physical Examinati on (IPPE) occurs at the outset of chronic care management services. It would allow the practitio ner to systematically gather information that can inform the care plan and it would allow the beneficiary the opportunity to address questions and concerns about wellness issues that may be important for those with multiple chronic conditions. With their required se rvices, the IPPE or AWV assures that at least once a year there is a focus on the broad wellness aspects of car e, which can easily be dominated by the more chronic conditions when they exist. In addition to the clinical benefits of the AWV or IPPE, these services provide administ rative benefits as well. They allows us to know the one practitioner the beneficiary has c hosen to furnish chronic care ma nagement services and assure that multiple practitioners cannot provide the servi ce to the same patient. However, in light of the widespread concerns raised by commenters about this requir ement, we have changed the

### CMS-1600-FC 627

requirement to a recommendation fo r a practitioner to furnish an AWV or IPPE to a beneficiary prior to billing for chronic care management servi ces furnished to that same beneficiary. As an alternative, a practitioner who m eets the practice standards that will be established to bill for chronic care management services ma y initiate services with an elig ible beneficiary as a part of an AWV, an IPPE, or a comprehensive E/M visit. 6. Chronic Care Management Services Furnished Incident to a Physician’s Service under General Physician Supervision In the proposed rule, we discussed the requirement s for billing for services fu rnished in the office, but not personally and directly performed by the ph ysician or qualified nonph ysician practitioner (referred to as a “practitioner” in the following discussion), und er our “incident to” requirements at 410.26 and in section 60, Chapter 15, of Medicare Benefit Policy Ma nual (100-02). One key requirement of “incident to” services is that a physician directly supervise the provision of services by au xiliary personnel by being in the office suite and be immediately available to furnish assistance and direction throughout the provision of the service. Section 60.4 of the Ma nual specifically discusses the one exception, which allows for general supervision of “incident to” services furnished to homebound patients in medically underserved areas. Under that exception, we identif y more specific requirements for the personnel who can provide “incident to” services under general supervis ion. For example, we require that the personnel must be employed by the physician billing the “incident to” services. One of the required capabilities for a physician to furnish chronic care management services is 24-hour-a-day, 7-day-a-week beneficiary access to the practice to address the patient’s chronic care needs. We would expect that the patient would be provided with a means to make timely contact with health care providers in the practice when necessary to address chronic care needs regardless of the time of day or day of the week. If the patient has a ch ronic care need outside of the practice’s normal business hours, the patient’s initial contact with the practice to address that need could be with clinical staff

### CMS-1600-FC 628

employed by the practice, (for example, a nurse) and not necessarily with a physician. Those services

could be furnished incident to th e services of the billing physician. We also proposed to require a minimum amount of time of chronic care services be furnished to a patient during a period for the physician to be able to bill separately for the ch ronic care services. The time, if not personally furnished by the physician, must be directed by the physician. We proposed that the time spent by a clinical staff person providing aspect s of chronic care services outside of the practice’s normal business hours during which there is no dir ect supervision would count towards the time requirement even though the services do not meet the direct supervision requirement for “incident to”

services. We stated our belief that the additional require ments we impose for auxiliary personnel under the exception for general supervision fo r homebound patients in medically underserved areas should apply in these circumstances where we are allowing a physicia n to bill Medicare for chronic care management services furnished under their general supervision and in cident to their professional services. In both of these unusual cases, these requirements help to ensure that appropriate services are being furnished by appropriate personnel in the absence of the direct superv ision. Specifically, we proposed that if a practice meets all the conditions required to bill separately for chronic care management services, the time spent by a clinical staff employee providing aspects of th ese services to address a patient’s chronic care need outside of the practice’s normal business hours can be counted towards the time requirement when at a minimum the following conditions are met:

● The clinical staff person is directly employed by the physician

● The services of the clinical staff person are an integral part of the physician’s chronic care management services to the patient (the patient must be one the physician is treating and for which an informed agreement is in effect), and are performed under the general supervision of the physician. General supervision means that the physician need not be physically present when the services are performed; however, the services must be performed under the physician’s overall supervision and

control. Contact is maintained between the clini cal staff person and the physician (for example, the

### CMS-1600-FC 629

employed clinical staff person contacts the physicia n directly if warranted and the physician retains professional responsibility for the service.)

● The services of the employed clinical staff person meet all other “incident to” requirements, compliance with applicable state law, wi th the exception of direct supervision.

Comment : The vast majority of commenters supporte d the idea of general rather than direct supervision, although we did receive comments on sp ecific aspects of our proposal. A few commenters said they recognized the difficulties in making excepti ons to the “incident to” policies. Some commenters supported the proposal as stated in the proposed ru le. Many commenters objected to the proposed requirement that the clinical staff person be directly employed by the physician, indicating that this would be a barrier to widespread adoption of the policy. Some commenters requested that we remove the employment requirement entirely, especially given that eligible practices will need to meet certain standards to be able to separately bill for chroni c care management services. Other commenters indicated that if CMS were to keep the employment requirement it should be modified to allow the clinical staff person to be an employee of the physician or an employee of the practice. Some commenters recommended that the policy be modified to allow the clinical staff person be either an employee or an independent contractor. These commenters stated a di stinction between the clinical staff person as an independent contractor and having the services provi ded under arrangement since typically the practice would directly supervise the contracted individual. A few commenters stated that a requirement to have all possible chronic care management services provi ded by employees would undermine access to these

services. Some commenters indicated that CMS should allow general rather than direct supervision for more situations, not just time spent by clinical staff outside of the practices normal business hours. For example, one commenter indicated that time spent by clinical staff providing chronic care management services to homebound patients in the patient’s home s should count towards the time requirement if provided under general supervision. Some comment ers expressed concern that our use of the word “physician” in this discussion could potentially create c onfusion that we are not also referring to qualified non-physician practitioners.

### CMS-1600-FC 630

Response : We appreciate the general support for our proposal as well as the recognition by some commenters of the challenges presented by the issue of an exception to “incident to related requirements,” even for this unusual case. We agree with the commenters who supported our policy as stated in the proposed rule si nce we continue to believe that within eligible practices the employment requirement helps ensure that appropriate services are being furnished by appropriate personnel under the lesser requirement of general supervision. We are clarifying that the clinical staff person furnishing the chronic care mana gement services could be employed either by the physician or the practice. Given the potential risk to the patient that exceptions to the direct physician supervision requirement could create, we believe it is appropriate to proceed deliberately in this area. We believe that this exception in this unusual case should be desi gned as narrowly as possible while still facilitating the chronic care management policy. Therefore, we disagree at the current time with commenters who requested broader exceptions to the direct physician supervision requirement to remove the employment requirement entirely, to include independent contractor s, or to include other situations for CY 2015. In response to commenters who stated that a requirement to have all possible chronic care management services provided by employees would undermine access to these services, we note that we did not propose such a requirement. Our proposed employment requirement was limited to allowing the time spent by a clinical staff employee in providing aspects of chronic care management services to address a patient’s chronic care need outside of th e practice’s normal business hours to count towards the time requirement for these services to be separately billed. To bill for “incident to” services, practitioners should follow all the usual “incident to” requirement s except when furnishing services outside of normal business hours under conditions that meet the require ments for the general supervision exception as

described above. We also note that our “incident to” policies apply to all pracitioners who can bill Medicare directly for services, and thus apply to physicians and other nonphysician prac titioners. As discussed in section II.J, we are aligning the requirements for “incid ent to” services to make clear that all practitioners

### CMS-1600-FC 631

who can bill Medicare for “incident to” services are subj ect to the same regulations at 410.26. We intend that the exception to the direct supervision require ment for after-hours chronic care management services furnished on an “incident to” basis will apply to all practitioners who can bill Medicare for services incident to their services and who can provide chronic care management services. In summary, we are finalizing our proposal for CY 2015 without modification except for our clarification that the clinical staff person furn ishing the chronic care management services could be employed either by the physician or the practice. In light of the concerns by some commenters th at our use of the word “physician” in this discussion could potentially create confusion that we are not also referring to qualified non-physician practitioners, we reiterate that, as we stated in the pro posed rule, “physician” in this discussion also refers to qualified non-phys ician practitioners. 7. Chronic Care Management Services and the Primary Care Incentive Payment Program (PCIP) Under section 1833(x) of the Act, the PCIP provides a 10 percent incentive payment for primary care services within a specific range of E/M serv ices when furnished by a primary care physician. Specific physician specialties and qualified nonphysician practitioners can qualify as primary care practitioners if 60 percent of their PFS allowed charges are primary care services. As we explained in the CY 2011 PFS final rule (75 FR 73435 through 73436), we do not believe the statute authorizes us to add codes (additional services) to the definition of primar y care services. However, to avoid inadvertently disqualifying community primary care physicians who follow their patients into the hospital setting, we finalized a policy to remove allowed charges for cer tain E/M services furnished to hospital inpatients and outpatients from the total allowed charges in the PCIP primary care percentage calculation. In the CY 2013 final rule (77 FR 68993), we adopted a policy that the TCM code should be treated in the same manner as those services for the purposes of PCIP because post-discharge TCM services are a complement in the community setting to the hospital- based discharge day management services already excluded from the PCIP denominator. Similar to the codes already excluded from the PCIP denominator, we expressed concern that inclusion of the TCM code in the denominator of the primary care percentage

### CMS-1600-FC 632

calculation could produce unwarranted bias against ‘‘tru e primary care practitioners’’ who are involved in furnishing post-discharge care to their patients. Chronic care management services are also similar to the services that we have already excluded from the from the PCIP denominator. For example, chronic care management includes management of care transitions within health care sett ings including referrals to other clinicians, visits following a patient visit to an emergency department , and visits following discharges from hospitals and skilled nursing facilities. Therefore, while phys icians and qualified nonphysician practitioners who furnish chronic care management services would not receive an additional incentive payment under the PCIP for the service itself (because it is not consider ed a ‘‘primary care service’’ for purposes of the PCIP), we proposed that the allowed charges for ch ronic care management services would not be included in the denominator when calculating a physician’s or practitioner’s percent of allowed charges that were primary care services for purposes of the PCIP.

Comment : Many commenters supported, and no commenters opposed, our proposed treatment of chronic care management services in the PCIP calculati on given that these services are not eligible for the incentive payment under the PCIP. Response : We agree with the commenters and are finalizing our proposal for CY 2015 without

modification.

### CMS-1600-FC 633

L. Collecting Data on Services Furnished in Off-Campus Provider-Based Departments

As we discussed in the CY 2014 PFS proposed rule (78 FR 43301) and CY 2014 OPPS/ASC proposed rule (78 FR 43626) , in recent years, the rese arch literature and popular press have documented the increased trend to ward hospital acquisition of physician practices, integration of those practices as a department of the hospital, a nd the resultant increase in the delivery of physicians’ services in a hospital setting (for example, we refer readers to Ostrom, Carol M., “Why you might pay twice for one visit to a doctor,” Seattle Times , November 3, 2012, and O’Malley, Ann, Amelia M. Bond, and Robert Berenson, Rising hospital employment of physicians: be tter quality, higher costs? Issue Brief No. 136, Center for Studying Health System Change, August 2011). When a Medicare beneficiary receives outpatient services in a hospital, the total payment amount for outpatient services made by Medicare is generally higher than the total payment amount made by Medicare when a physician furnis hes those same services in a freestanding clinic or in a physician’s offi ce. As more physician practices become hospital-based, news articles have highlighted beneficiary liability that is incurred when services are furnished in a hospital-based physician practice. MedPAC ha s questioned the appropriateness of increased Medicare payment and beneficiary cost-shari ng when physicians’ offices become hospital outpatient departments and has recommended that Medicare pay selected hospital outpatient services at the MPFS rates (MedPAC March 20 12 Report to Congress; “Addressing Medicare Payment Differences across Settings,” pres entation to the Commission on March 7, 2013). The total payment generally is higher when outpatient services are furnished in the hospital outpatient setting rather than a freestandi ng clinic or a physician o ffice. When a service is furnished in a freestanding clinic or physic ian office, only one payment is made under the

### CMS-1600-FC 634

MPFS; however when a service is furnished in a hospital-base d office, Medicare pays the hospital a “facility fee” a nd a payment for the physician portion of the service, which is a lower payment than if the service would have been fu rnished in a physician’ s office. Although the physician payment is lower when the services ar e furnished in a hospital, the total payment (facility fee and phys ician fee) is generally more than th e Medicare payment if the same service was furnished in a freestanding clinic or physician office. The beneficiary pays coinsurance for both the physician payment and the hospital outpatient payment (facility fee). Upon acquisition of a physician practice, hospitals frequently treat the practice lo cations as off-campus providerbased departments of the hospital and bill Medicare for services furnished at those locations under the OPPS. (For further information on th e provider-based regulati ons at §413.65, we refer

readers to http://www.gpo.gov/fdsys/pkg/CFR-2010-title 42-vol2/pdf/CFR- 2010-title42-vol2- sec413-65.pdf ). Since October 1, 2002, we have not re quired hospitals to seek from CMS a determination of provider-based status for a facil ity that is located off campus. We also do not have a formal process for gathering information on the frequency, type, and payment of services furnished in off-campus provider-ba sed departments of the hospital. We stated in the CY 2014 proposed rules that in order to better understand the growing trend toward hospital acquisition of physician offices and subsequent treatment of those locations as off-campus provider-based outpatient depa rtments, we were considering collecting information that would allow us to analyze the frequency, type, and payment of services furnished in off-campus provide r-based hospital departments. We stated that we have considered several potential methods. Claims-bas ed approaches could in clude (1) creating a new place of service code for off campus departme nts of a provider under §413.65(g)(2) as part of item 24B of the CMS–1500 claim form, comparable to current place of se rvice codes such as

### CMS-1600-FC 635

‘‘22 Outpatient’’ and ‘’23 Emergency Room-Hospita l’’ when physician services are furnished in an off-campus provider-based department, or (2) creating a HCPCS modifier that could be reported with every code for services furnished in an off-campus provider-based department of a hospital on the CMS–1500 claim form for physicia n services and the UB–04 (CMS form 1450) for hospital outpatient claims. In addition, we ha ve considered asking hospitals to break out the costs and charges for their provid er-based departments as outpatie nt service cost centers on the Medicare hospital cost report, form 2552-10. We noted that some hospitals already break out these costs voluntarily or because of cost re porting requirements for the 340B Drug Discount Program, but this practice is not consistent or standardized. In the proposed rules, we invited public comments on the best means for collec ting information on the frequency, type, and payment of services furnished in off-campus provider-based departments of hospitals.

Comment : Although most commenters agreed on th e need to collect information on the frequency, type, and payment for services furn ished in off-campus provided-based departments of hospitals, opinions differed on how to best co llect this additional da ta. Some commenters preferred identifying servi ces furnished in provider-based de partments on the cost report, while others preferred one of the claims-based a pproaches. Some commenters supported either approach, noting the trade-offs in terms of the type of data that could be collected accurately and

the administrative burden involve d. Some suggested we convene a group of stakeholders to develop consensus on the best approach. Comm enters generally recommended that CMS choose the least administratively burdensome approach th at would ensure accurate data, but did not necessarily agree on what appro ach would optimally achieve that result. For example, limiting the data collection to cost report approaches resu lts in little administra tive burden for physicians

### CMS-1600-FC 636

since they do not file cost repo rts, but could result in varying de grees of administrative effort for hospitals depending on the specific co st reporting requirements. Several commenters noted that some hospitals already voluntarily identify costs specific to provider-based departments on their cost reports. Since cost and charge information is already reported separately, these commenters asserted there would be no a dditional burden, although additional variables or changes to the structure of the cost repor t may be required. In addition, the commenters noted that cost report info rmation would be transparent and audited for accuracy. One commenter recommended aggregat e reporting of all off-campus provider-based departments as one or several cost centers, a nd another indicated that CMS should consider assigning separate sub-provider num bers for off-campus departments similar to those used for rehabilitation and psychiatric units. However, other commenters believed that a HCPCS modifier would more clearly identify specific services provided and would provide better information about the type and level of care

furnished. Some commenters believed a HCPCS modifier would be the least administratively burdensome as hospitals and physicians already report a number of claims-based modifiers. However, other commenters used this same f act about the number of existing claims-based modifiers to argue that additional modifiers w ould increase administrative burden since it would

increase the number of modifiers that needed to be considered when billing. These commenters

and others recommended that CMS should consider the establishment of a new Place of Service (POS) code since they believed it would be le ss administratively burdensome than attaching a

modifier to each service on the claim that wa s furnished in an off-campus provider-based department. Some commenters stated that establishing a new POS code would work better under

the PFS than the OPPS since under th e OPPS a single claim was more likely to contain lines for

### CMS-1600-FC 637

services furnished in both on-campus and off-cam pus parts of the hospital on the same day for the same beneficiary. MedPAC believes there may be some limite d value in collecting data on services furnished in off-campus provide r-based departments to validate the accuracy of site-of-service reporting when the physician office is off-campus but billing as an outpatient department, but did not recommend a particular data collection a pproach. MedPAC emphasized that any data collection effort should not prev ent the development of policies to align payment rates across settings. Response : We appreciate the public feedback in response to our comment solicitation in the proposed rules. We will take the comments r eceived into consideration as we continue to consider approaches to collecting data on serv ices furnished in off-campus provider-based departments.

### CMS-1600-FC 638

M. Chiropractors Billing for Ev aluation & Management Services Section 1861(r)(5) of the Act in cludes chiropractors in its de finition of “physician” with language limiting chiropractors to “treatment by means of manual manipulation of the spine (to correct a subluxation).” In accordance with the statute as we noted on page 43342 of the CY2014 proposed rule, chiropractic c overage, therefore, is limited to treatment of subluxation of the spine and payment can only be made for that purpose. Specifically, we make payment for only the following three codes listed in the chiropractic section of the CPT Manual: 98940 – Chiropractic manipulation treat ment (CMT), spinal, 1-2 regions 98941 – CMT spinal, 3-4 regions 98942 – CMT spinal, 5 regions We solicited comments in the CY2014 proposed ru le regarding the appropriateness of the billing of E/M services by chiropractors although we did not propose to pay chiropractors for

E/M services in 2014. We wanted to determin e whether there are situ ations in which E/M services not included in Chiropractic Mani pulative Treatment (CMT) codes 98940-98942 would meet the statutory requirements for chiropractic services and therefore, could be appropriately

billed. To achieve that goal, we asked that information be submitted regarding the following: the services that would be provide d; the benefits that would accr ue including whether access to chiropractic services for Medica re beneficiaries would be expa nded; the justif ication for E/M services beyond those included in the CMT codes; the appropriaten ess of allowing billing for all

office E/M codes for new or existi ng patients; the specific creation of one or a set of codes for chiropractic E/M services; the frequency that chiropractors should be allowed to bill E/M services; and the volume th at could be expected.

### CMS-1600-FC 639

Although very few commenters submitted comments that addressed all of the information we requested in the proposed rule, we do thank all the commenters for th eir input. Any possible changes to our current policy on allowing chiropractors to bill E/M services will be addressed in future notice and comment rulemaking.

### CMS-1600-FC 640

III. Other Provisions of the Proposed Regulations A. Medicare Coverage of Items and Servi ces in FDA-Approved Investigational Device Exemption Clinical Studies--Revisions of Medicare Coverage Requirements 1. Background and Statutory Authority

a. General Section 1862(m) of the Act (established by s ection 731(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173, enacted on December 8, 2003)) allows for payment of the routine costs of care furnished to Medicare beneficiaries in a Category A investigational device exemption (IDE) trial and authorizes the Secretary to establish criteria to ensure that Category A IDE trials conform to appropriate scientific and ethical standards. By providing Me dicare coverage of rou tine costs in Category A trials, the Congress removed a financial barrier that may have discouraged beneficiaries from participating in these trials. It also gives Medicare beneficiaries the opportunity to have earlier access to new medical devices. However, the statute does not require Medicare to cover the Category A device itself. We not e that throughout this section of the preamble, the words study and trial are used interchangeably. (1) Category A IDE devices For Category A IDE devices, existing §405.201(b) defines an “experimental/investigational (Cat egory A) device” as an innova tive device believed to be in

Class III for which “absolute risk ” of the device type has not been establis hed (that is, initial questions of safety and effectiveness have not been resolved and the FDA is unsure whether the device type can be safe and e ffective). Existing §405.207( b)(2) states that payment may be made

for the routine care services related to Cate gory A IDE devices if, among other things, the services are furnished in conjunc tion with an FDA-approved clinical trial, and that the trial is

### CMS-1600-FC 641

required to meet criteria established through th e Medicare national c overage determination

process. (2) Category B IDE devices Existing §405.201(b) defines a “non-experiment al/investigational (C ategory B) device”

as a device believed to be in Cla ss I or Class II, or a device believed to be in Class III for which the incremental risk is the primary risk in quest ion (that is, underlying qu estions of safety and effectiveness of that device type have been resolv ed), or it is known that the device type can be safe and effective because, for example, othe r manufacturers have obtained FDA approval for that device type. Existing §405.211 allows Medicare contractors to make coverage decisions for non-experimental/investigational (C ategory B) devices if certain requirements are met. If a

Medicare contractor determines that a Category B device is covered, Medicare also covers routine care services related to a non-experimenta l/investigational (Category B) device furnished in conjunction with an FDA-approved clini cal trial, per §405.207(b )(3). Based on our rulemaking authority in section 1871 of the Ac t, we proposed to apply the same Medicare coverage requirements and scien tific and ethical standards to Medicare coverage related to Category B IDE studies/trials that would be applicable to Category A IDE studies/trials. b. Background We sought and received input from stake holders (for example: manufacturers, study sponsors, and hospitals) regardi ng the Medicare coverage approva l process for Category B IDE devices. The majority of stakeholders told us that obtaining Medicare co verage of the Category

B IDE device and the costs of routine items and services is inefficient since local Medicare contractors have differing processes for revi ewing IDE studies for purposes of Medicare coverage, which result in inconsistent Medi care coverage of Cate gory B IDE devices and

associated routine care services across the Medica re contractor jurisdictions. Stakeholders also

### CMS-1600-FC 642

suggested that these factors contri bute to their reluctance to enro ll Medicare beneficiaries in IDE trials and studies, and that Me dicare coverage variab ility between Medicare contractors made it

difficult to conduct national IDE trials. We also requested input from local Medi care contractors regarding their existing processes for determining coverage of Categor y B IDE devices and associated routine care services. They reported that they review pertinent availabl e evidence and the FDA-approved IDE trial protocol as factors in their decision-making process to ensure that the device is reasonable and necessary for Medicare beneficiarie s and furnished in appropr iate settings. Local Medicare contractors appl y varying levels of scrutiny to thes e factors. While most Medicare contractors extensively review IDE study protocols, other cont ractors may review them less extensively. Although there is va riability among contract ors, in many cases the review processes are duplicative in that multiple Medicare contract ors are reviewing the same materials in the

same way. 2. Summary of Provisions of the Proposed Regulation We proposed to modify our regulations rela ted to Medicare cove rage of routine care items and services in Category A IDE studies and trials, and Me dicare coverage of Category B

IDE devices and routine care items and services. We proposed to establish criteria for IDE studies so that Category A IDE tr ials conform to appropriate scie ntific and ethical standards for Medicare coverage consistent with our author ity under section 1862(m)(2)(B ) of the Act. We proposed to extend the same Medicare coverage requirements to Medicare coverage of Category B IDE device trials, using our general rulemaking authority under section 1871 of the Act. We proposed that Medicare coverage de cisions related to coverage of items and services in Category

A and B IDE trials and studies be made by CMS centrally. a. Proposed Definitions

### CMS-1600-FC 643

We proposed to replace the definitions in §405.201(b) with the following:

● Category A (Experimental) device : A device for which “absol ute risk” of the device type has not been established (tha t is, initial questions of safety and effectiveness have not been resolved) and the FDA is unsure whether the de vice type can be safe and effective.

● Category B (Nonexperimental/investigational) device : A device for which the incremental risk is the primary risk in ques tion (that is, initial que stions of safety and effectiveness of that device type have been reso lved) or it is known that the device type can be safe and effective because, for example, othe r manufacturers have obtained FDA approval for that device type.

● ClinicalTrials.gov : The National Institutes of Health ’s National Library of Medicine’s online registry and results database of publicly and privately supported clin ical studies of human participants conducted around the world.

● Contractors : Medicare Administrative Contractors and other entities that contract with CMS to review and adjudicate clai ms for Medicare items and services.

● IDE stands for invest igational device exemption : An FDA-approved IDE application permits a device, which would otherwise be subject to marketing approval or clearance, to be shipped lawfully for the purpose of conducting a clinical study in accordance with 21 U.S.C. 360j(g) and 21 CFR parts 812.

● Pivotal studies or trials : Clinical investigations designe d to collect definitive evidence of the safety and effectiveness of a device for a sp ecified intended use, typi cally in a statistically justified number of subjects. It may or may not be preceded by an early and/or a traditional feasibility study.

● Routine care items and services : Items and services that are otherwise generally

available to Medicare benefici aries (that is, a benefit categor y exists, it is not statutorily

### CMS-1600-FC 644

excluded, and there is not a nati onal noncoverage decision) that are furnished in either the experimental or the control arms of a clinical trial and that woul d be otherwise furnished even if the beneficiary were not enroll ed in a clinical trial.

● Superiority studies or trials : Studies or trials that are intended to demonstrate at some prespecified level of confidence that the effect of an investigational treatment is superior to that of an active control by more th an a prespecified margin. b. Proposed Provisions for Medi care coverage of items and services in FDA-approved IDE

studies. To ensure that Medicare coverage of items and services in Category A and B IDE studies

is more consistent across Medicare administ rative regions, we proposed that IDE coverage decisions be made by CMS centrally. We proposed a centralized IDE cove rage review process for Category A and Category B IDEs, by addi ng §405.201(a)(3) stating th at CMS identifies criteria for coverage of items and services fu rnished in IDE studies. We proposed to replace existing §405.211 with the following Medicare coverage requirements for items and services in Category A and Category B F DA-approved IDE studies.

● CMS will review the following items and s upporting materials as needed: (1) the FDA approval letter, (2) IDE study protocol, (3) I RB approval letter(s), (4) Clinical Trials.gov

identifier.

● Medicare may cover routine care items and services furnished in any FDA-approved Category A IDE study if the criteria in pr oposed new §405.212(a) and (b) are met.

● Medicare covers a Category B IDE de vice and routine care items and services furnished in any FDA-approved Category B ID E study if the criteria in proposed new §405.212(a) and (c) are met.

● If an IDE device is furnished in an F DA-approved IDE study that does not wholly fall

### CMS-1600-FC 645

under proposed new §405.212(b) or (c), CMS consid ers whether the study’s attainment of the criteria in proposed new §405.212(a) are sufficient to mitigate the failure to meet the criteria in proposed new §405.212(b) or (c). We also proposed to notify the public of Medicare covered Category A and B IDE studies by posting the IDE study title and Clinic alTrials.gov identifier on the CMS coverage website and publishing a list of trials in the Federal Register . We stated that a centralized review process would be more efficient by reduci ng the burden for stake holders interested in seeking Medicare coverage related to nationwide IDE studies or tr ials. Having a single entity making Medicare coverage decisions would enhance administrative efficiency by eliminating the need for duplicative submissions from stakehol ders to different Me dicare contractors and duplicative reviews by Medica re contractors. In the preamble to the proposed rule, we stated that we did not believe that the proposed cove rage requirements would significantly change the number of items and services covered compared to coverage under existing requirements. We stated in the preamble to the proposed rule that any interested party who seeks Medicare coverage related to a Category A or B IDE study may send us a request letter that describes the scope and nature of the Category A or B IDE study, discussing each of the criteria in the proposed policy. Requests w ould be submitted via email to clinicalstudynotific ation@cms.hhs.gov or via hard copy to the following address: Centers for Medicare & Medicaid Services; Center for Clinic al Standards & Quality; Director, Coverage and Analysis Group; ATTN: Clinical Study Certific ation; Mailstop: S3-02-01; 7500 Security Blvd; Baltimore, MD 21244. c. Proposed Medicare Cove rage IDE Study Criteria: We proposed to add a new §405.212 that describe s the Medicare coverage criteria that Category A and B IDE studies or trials must meet in order for Medicare to cover routine care

### CMS-1600-FC 646

items and services in Category A IDE studies or trials, and for Medica re to cover Category B

IDE devices and routine care items and serv ices (per proposed revised §405.207 and §405.211). We proposed the following Medicare coverage IDE study criteria. (1) The principal purpos e of the study is to test whethe r the item or service meaningfully improves health outcomes of patients who are re presented by the Medicare-enrolled subjects. (2) The rationale for the study is well s upported by available scientific and medical information, or it is intended to clarify or esta blish the health outcomes of interventions already

in common clinical use. (3) The study results are not anticipated to unjustifiably dupli cate existing knowledge. (4) The study design is methodologically a ppropriate and the antic ipated number of enrolled subjects is adequate to answer the research question(s) being asked in the study. (5) The study is sponsored by an organiza tion or individual capab le of completing it successfully. (6) The study is in compliance with all ap plicable Federal regul ations concerning the protection of human subjects found at 45 CFR part 46. (7) All aspects of the study ar e conducted according to approp riate standards of scientific integrity set by the International Committee of Medical Journal Editors. (8) The study has a written protocol that cl early demonstrates adhe rence to the standards

listed here as Medica re requirements. (9) Where appropriate, the clinical research study is not designed to exclusively test toxicity or disease pathophysiology in healthy in dividuals. Trials of all medical technologies measuring therapeutic outcomes as one of the obj ectives may be exempt from this standard only if the disease or condition being studied is life threat ening as defined in 21 CFR 312.81(a) and the patient has no other viable treatment options.

### CMS-1600-FC 647

(10) The study is registered on the Clinic alTrials.gov website and/ or the Registry of Patient Registries (RoPR) by the pr incipal sponsor/investigator prior to the enrollment of the first study subject. (11) The study protocol specifies the met hod and timing of public release of results on all pre-specified outcomes, including release of negative outcomes. The release should be hastened if the study is terminated early. The re sults must be made public within 24 months of

the end of data collection. If a report is planned to be published in a peer reviewed journal, then that initial release may be an abstract that m eets the requirements of the International Committee of Medical Journal Editors. However, a full repo rt of the outcomes must be made public no later than 3 years after the end of data collection. (12) The study protocol explicitly discu sses subpopulations affected by the item or service under investigation, partic ularly traditionally underrepresen ted groups in clinical studies,

how the inclusion and exclusion criteria [a]ffect enrollment of these populations, and a plan for the retention and reporting of sa id populations in the study. If the inclusion and exclusion criteria are expected to have a negative effect on the recruitmen t or retention of underrepresented populations, the protocol must discuss why these criteria are necessary. (13) The study protocol explicitly discusses how the results are or ar e not expected to be generalizable to subsections of the Medicare population to infe r whether Medicare patients may

benefit from the intervention. Separate discussions in the pr otocol may be necessary for populations eligible for Medica re due to age, disability, or Medicaid eligibility. We stated in the preamble to the proposed rule that all IDE inves tigational device studies where Medicare coverage is sought should conform to rigorous scientific and ethical standards.

We believe that these criteria are essential to protecting Medica re study participants in Category A and Category B trials. Studies that have hi gh scientific and ethical standards lead to

### CMS-1600-FC 648

generalizable and reliable knowledge for the Medicare program including, providers, practitioners, and beneficiaries. We believe that additional Medicare coverage criteria are needed for Category A and B IDE studies where Medicare coverage for items a nd services is sought, to ensure that the study design is appropriate to answer questions of importance to the Medicare program and its beneficiaries. Although an item or service ma y be considered appropriate when used by a

clinician for the benefit of an individual patient, it may not be reasonable and necessary when

used in the context of an IDE st udy or trial for purposes of Medica re coverage. The use of such a device in an IDE study or trial may expose study participants to increased risks that must be balanced by other factors, including the lik elihood that the study would add important information to the body of medical knowledge relevant to the Medicare program. While most studies are undertaken only af ter a detailed protocol has been developed, some are not. The protocol is the primar y source of knowledge on the proposed design and management of the study. Without this documen t, reviewers and funding entities are unable to ascertain the quality and validity of the study, and whether the st udy is appropriate to answer questions of importance to the Medicare program. The exercise of comm itting to paper all the aspects of the study is crucial to ensuring that all pot ential concerns have been addressed. We proposed these 13 Medicare coverage IDE study criteria because we believe they must be integral to any study th at is approved for purposes of Me dicare coverage. The proposed

first four criteria and the seve nth criterion were de veloped because they embody ethical values. The fifth and sixth proposed criteria were de veloped in response to reports of egregious misconduct in the past in endeavors to conduct clini cal research by placing i ndividuals at the risk of harm for the good of others. In §405.211, we proposed that if the following two characteristics are also met, in

### CMS-1600-FC 649

addition to the IDE study criteria listed in proposed new §405.212(a)(1) through (a)(13), we would automatically cover the co sts of routine items and servi ces in the Category A study or trial, and the costs of the inve stigational device and the routine items and services in a Category B study or trial as follows:

● The study is a pivotal study.

● The study has a superiority study design. Existing §405.207(b)(2) requires that for Medicare coverage of related routine care services, all Category A IDE studi es and trials must meet the criteria estab lished through the NCD process. We proposed to modify §405.207(b) to remove the NCD process requirement and state that payment may be made for rou tine care items and services related to experimental/investigational (Category A) devi ces as defined in §405.201(b), and furnished in conjunction with an FDA-approved clinical trial that meets th e Medicare coverage IDE study criteria in proposed new §405.212. We proposed to modify §411.15(o)(2) to specify that the exclusions from Medicare coverage include experimental or inve stigational devices, except for

certain devices furnished in accordance with the Medicare coverage requirements proposed in revised §405.21l. 3. Summary of Public Comments

We received 48 comments from various enti ties including the medical device industry, academic medical centers, health care systems, c onsultants, and medical societies. Regarding centralization of the IDE review process, comm enters’ opinions were mixed with the majority requesting additional details about the centralized review process, clarification of the IDE study criteria, and delayed implementation of the rule . Commenters expressed concerns about the proposed IDE study criteria, believing that they were duplicative of FDA review activities and suggested that CMS allow for additi onal input from stakeholders befo re the rule is finalized. The

### CMS-1600-FC 650

following is a summary of the comments we received and our responses.

a. Definitions

Comment : Commenters were concerned that ou r proposed definition of routine care

items and services would limit Medicare coverage of routin e care items and services related to Category A or Category B IDE studies. The commen ts suggested that we align this definition

with section 310.1 of the Medicare NC D Manual (Clinical Trials). Response : We appreciate the commenters’ feed back. While we believe that this

definition of routine care items and services is aligned with secti on 310.1 of the Medicare National Coverage Determinations Manual, for purposes of clarity, we are modifying this

definition to refer to items and services that are otherwise generall y available to Medicare beneficiaries (that is, a benefit category exists , it is not statutorily excluded, and there is no national noncoverage decision) th at are furnished during a clin ical study and that would be

otherwise furnished even if the beneficiary were not enro lled in a clinical study. b. Provisions for Medicare Coverage of Items and Services in FDA-a pproved Category A or B

IDE studies or trials

Comment : Several commenters were generally s upportive of the concep t of a centralized Medicare review process for Category A and B ID E studies for purposes of Medicare coverage. However, the commenters requested additional information regarding submission format and review timeframes, with some commenters concer ned about the availability of appropriate staff at CMS to complete reviews and issue approvals . Commenters also asked for clarification regarding appeals of Me dicare coverage decision s related to Category A or B IDE studies and evaluation/oversight of the CMS Medi care coverage review process. Response: Seeking Medicare coverage related to Category A or B IDE studies is voluntary. While we are finalizi ng this rule, we are delaying implementation of these changes

### CMS-1600-FC 651

until January 1, 2015. Upon implementation of these changes, interested parties, such as the study sponsor, that wish to seek Medicare coverage in Category A or B IDE studies must submit their requests via email to clinicalstudynotific ation@cms.hhs.gov or via hard copy to the following address: Centers for Medicare and Medi caid Services; Center for Clinical Standards and Quality; Director, Coverage and Analysis Gr oup; ATTN: Clinical Study Certification; Mail Stop S3-02-01; 7500 Security Blvd.; Baltimore, MD 21244. Requests must include the following information:

● A request letter that de scribes the scope and nature of the IDE study, discussing how the interested party believes that the IDE study meets each Medicare Coverage IDE Study

Criteria.

● FDA approval letter of the IDE.

● IDE study protocol.

● IRB approval letter.

● National Clinical Trial (NCT) number.

● Supporting materials, as appropriate. We understand and appreciate commenters’ c oncerns regarding review time and the availability of appropriate staff to complete th e reviews. Once a complete request is received by CMS (or its designated entity), we expect that the review timeframe will be approximately 30 days. While we believe that we have sufficient resources to pr ocess Medicare coverage reviews of the IDE studies, we are modifying the provis ions of section 405.211 to allow for reviews by a CMS-designated entity if future needs arise. We anticipate that claims for routine care ite ms and services related to Category A or B IDE studies and claims for Category B IDE devi ces will continue to be submitted to local Medicare contractors who will identify routine costs for which Medicare payment is made for

### CMS-1600-FC 652

each related claim. We plan to issue appropriate manual instructions to Medicare contractors. Additional information regarding Medicare claim appeals is available on the CMS website at http://www.cms.gov/Medicare/Appeals-and- Grievances/OrgMed FFSAppeals/index.html

. Comment : A few commenters opposed a centralized Medicare coverage process for Category A or B IDE studies and believed that the current local Medicar e contractor review process is sufficient, that centralization coul d increase approval time, and may not have the intended impact of eliminating in consistencies in coverage. Seve ral commenters suggested that CMS focus on streamlining claims processing for routine costs incurred by Medicare beneficiaries participating in clinical trials. One commenter was concerne d that local Medicare contractors may impose additiona l coverage requirements. Response : While some stakeholders may be satisf ied with the current localized coverage review process, we believe that centralizi ng the submission, review and determination of Medicare coverage IDE study re quests enhances administrative efficiency by eliminating the need for duplicative submission of requests by providers and duplicative reviews by local Medicare contractors. For example, under existing procedures, each provider that participates in an IDE trial and that anticipates filing Medicare claims must notify the Medicare contractor and

furnish the contractor with certain information a bout the IDE trial. Once the contractor notifies the provider that all re quired information for the IDE study has been furnished, the provider may bill related Category A or B IDE claims. Effective January 1, 2015, intere sted parties (such as study s ponsors) that wish to seek Medicare coverage related to Category A or B IDE studies, will have a centralized point of contact for submission, review and determinatio n of Medicare coverage IDE study requests. Providers will no longer need to notify individu al contractors regardi ng IDE studies for which they plan to submit claims since CMS-approved Category A and B IDE studi es will be listed on

### CMS-1600-FC 653

the CMS website and in the Federal Register . We encourage provide rs to check the CMS website to see if an IDE study has been appr oved for coverage before submitting IDE related

claims.

Comment : Some commenters believed that the Medicare coverage requirements duplicate the responsibilities of the FDA (such as re view of scientific and ethical standards) with commenters suggesting that CMS deem coverage for Category A or B IDE studies that have received FDA and IRB approval. Response : CMS and FDA operate under different statutory author ities and have distinct authorities and responsib ilities. FDA approves IDE studies or trials when, among other things, the risks to the subjects are outweighed by the anticipated benefits and the importance of the knowledge to be gained. For purposes of Medicar e coverage, we seek evidence that an item or

service is reasonable and necessa ry. The disease burden borne by elderly individuals and the important health care interventions unique to the Medicare population are important areas of focus for the Medicare program; we would not e xpect the FDA review to include substantive

consideration of these Medicare priorities. Thus, we believe th at Medicare coverage standards

are needed for IDE studies for which Medicare c overage is sought. We wish to ensure that

Medicare beneficiaries who voluntee r to participate in studies ar e protected, that the study design is appropriate to answer questions of importance to the Medicare pr ogram, and to ensure that the information gained from important clinical trials could be used to inform Medicare coverage

decisions. There are numerous studies that may be consid ered scientifically valid but are of little

benefit to Medicare beneficiarie s or to the Medicare program. We believe that this policy

establishes Medicare coverage requirements that need to be met to best support a body of clinical knowledge that is relevant to the Medicare program and its beneficiarie s. It is essential that IDE

### CMS-1600-FC 654

studies where Medicare coverage is sought serve the best interest s of the Medicare program and its beneficiaries; and that they be useful in improving healthcare delivery to Medicare beneficiaries, and informing Me dicare coverage.

Comment : Commenters suggested that the pr oposed coverage requirements would

increase burden and create access barriers for Me dicare coverage of Category A IDE routine care items and services and Category B IDE devices and routine care ite ms and services, particularly

in small or localized studies or trials. Commen ters suggested that these changes may decelerate medical device innovation and that many sponsors may choose not to seek Medicare coverage for IDE trials due to possible de lays during the transition to thes e new coverage requirements. Other commenters suggested that we pilot a voluntary centralized c overage review process for at least a year, or establish separa te review processes for small and large studies since commenters believed that the existing review process by local Medicare contractors is appropriate for small, single-site studies, and that centra lized review should only be app lied to large, national studies. Some commenters requested clar ification regarding whether Me dicare would automatically cover items and services related to Category A or B IDE studies, if the studies met the criteria in proposed new §405.212. Response : Seeking Medicare coverage related to Category A or B IDE studies is voluntary under existing procedures and will conti nue to be voluntary under the provisions of this final rule. Study sponsors are not required to seek Medicare coverage in order to conduct their studies or trials. Establishing separate Medicare coverage for IDE study review processes for large and small studies would create unnece ssary infrastructure. Similarly, piloting the centralized Medicare coverage IDE study review process woul d create more duplication and variation in reviews and coverage of items and services, in add ition to the variation currently present under the existing local Medicare contractor review process.

### CMS-1600-FC 655

In this final rule, we are re vising §405.211(a) to specify that Medicare covers routine care

items and services that are furnished in FDA- approved Category A IDE studies if CMS (or its designated entity) determines that the IDE stud y criteria in §405.212 are met. We are also revising §405.211(b) to specify th at Medicare may make payment for Category B IDE devices

and routine care items and services furnished in FDA-approved Category B IDE studies if CMS (or its designated entity) determines that the IDE study criteria in §405.212 are met.

Comment : One commenter expressed concern that beneficiaries could be at risk of losing Medicare coverage for medical emergencies and other health care items and services that

would otherwise be available to Medicare bene ficiaries outside of an IDE study or trial. Response : We do not believe this policy will have an impact on coverage for treatment of an individual trial participan t with a medical emergency because this policy does not address Medicare coverage provisions outsi de the context of a Category A or B IDE study or trial. We would not expect to make a separate review of the IDE study information submitted to CMS (or its designated entity) for each enrolled subjec t or each related claim submitted to Medicare contractors for adjudication. Additionally, we ar e unaware of any current paradigm by which an FDA approved IDE trial would be conceived, developed, reviewed and approved in such a short timeframe, that is, a few minutes or hours, to ad dress a beneficiary’s medical emergency.

Comment : Commenters requested information a bout what role, if any, the FDA would serve in the proposed centralized IDE review process for purpos es of Medicare coverage of Category A IDE routine care items and services and Category B IDE devices and routine care

items and services. Response: We did not propose any change s to §405.203, which addresses FDA categorization of IDE devices and subsequent FDA notification to CMS regarding such categorization.

### CMS-1600-FC 656

c. Medicare Coverage IDE Study Criteria

Comment: Many commenters believed that proposed criterion 1 (the pr incipal purpose of the study is to test whether the item or serv ice meaningfully improves health outcomes in patients who are represented by the Medicare-e nrolled subjects), was too specific to the Medicare population and should more closely a lign with FDA requirements since IDE studies are designed to answer FDA regulatory questi ons, not Medicare or other insurer coverage questions. Some commenters suggested that we modify the standard to indicate that measuring meaningful outcomes in Medicare beneficiaries need not be th e principal purpose, but only one of the purposes. Response: As discussed in the preamble to th e proposed rule, we believe that this criterion is necessary because it embodies importa nt scientific and ethical considerations needed to ensure that the study design is appropriate to answer questions of im portance to Medicare and its beneficiaries. We expect that the results of all approved studies will specifically benefit the Medicare population and, as such, covered studies or trials must address how the study will

affect Medicare beneficiaries if it desires to receive Me dicare payment for services provided to

Medicare beneficiaries within that study. However, based on the comments received, we are modifying this criterion to state that the principal purpose of th e study is to test whether the device improves health outcomes of appropriately selected patients, since a discussion of the potential benefit of the device be ing studied to the applicable Me dicare population is implicit in

other criteria.

Comment : Commenters suggested that we re move or modify the second proposed criterion (the rationale for the study is well supported by available sc ientific and medical information, or it is intended to clarify or esta blish the health outcomes of interventions already in common clinical use). Commen ters believed that there is al ready well established government

### CMS-1600-FC 657

oversight, and self-governance thro ugh IRBs and scientific review committees. The commenters requested additional guidance regarding how this criterion would align with FDA requirements and oversight through the IRBs and scientific committees. Response : Study protocols typically have a section that describes the sc ientific rationale

for the research. We believe that this criteri on reflects a fundamental principle of research and does not require something that w ould otherwise be absent from a bona fide clinical study protocol. We seek assurance of compliance with th is criterion because it is needed to ensure that the study or trial focuses on health outcomes important to the Medi care program and its beneficiaries. Therefore, we are not making changes to this criterion.

Comment : Some commenters were concerned about how proposed criterion 3 (the study results are not anticipated to unjustifiably duplicate existing know ledge) would affect IDE device

studies that are versions of devices already on the market. A commenter believed that this

criterion should not be used to restrict Medicare coverage of IDE studies that build on an existing body of evidence or that provide c onfirmatory data on new devices. Response : We realize that FDA reviews many new de vices being tested in IDE trials that may be similar to devices already on the market, and that this process is a necessary part of competition and innovation. However, because we ar e not assured that all devices of a similar class will necessarily have identica l benefits and harms, we do not believe, as a general principle,

that IDE studies or trials a ddressing new device versions alwa ys duplicate prior knowledge. We expect that knowledge about new devices or si gnificantly changed devices will add to, rather than duplicate, existing knowledge. We believe this criterion is necessary to ensure that the study focuses on health outcomes important to th e Medicare program and its beneficiaries. Therefore, we are not making ch anges to this criterion.

Comment : Commenters stated that proposed criterion 4 (the study design is

### CMS-1600-FC 658

methodologically appropriate and th e anticipated number of enroll ed subjects is adequate to answer the research question( s) being asked in the study) is duplicative of the FDA’s role. One

commenter asked how we would determine if a study design is methodologically appropriate. Response : Fundamentally, bona fide clinical research depends on the use of study designs that are appropriate to address the study questions. Othe rwise there is no real production of generalizable knowledge, which is the hallmark of research, and enrolled subjects encounter risk without a realistic expectation that their pa rticipation will result in personal or societal

benefit relevant to the Medicare program. The use of such a device in an IDE study may expose the study participants to increased risks that mu st be balanced by other factors including the likelihood that the study would add important information to the body of medical knowledge relevant to the Medicare program. There ar e numerous studies that may be considered scientifically valid but are of little benefit to the Medicare program. We are sensitive to the unique needs of Medicare beneficiaries, particul arly the elderly. A trial design that may be adequate for a generally younger population may be comparatively insensitiv e to clinical factors commonly found in the elderly that may adversely im pact the potential benef it or tolerability of a device, which is of particular im portance to the Medicare program.

Comment : A few commenters requested inform ation on how proposed criterion 5 (the study is sponsored by an organization or individual capable of completing it successfully) will be used to determine that the sponsoring organizatio n or individual is capab le of completing a study successfully. Response : Institutional capabilities and scientific expertise are typically described in study protocols, which will be reviewed by CMS. Robust clinical studies depend on a supporting infrastructure to assure protocol adherence and that intended patient protections are actually in place. Clinical trials that are not completed successfu lly expose enrolled subjects to

### CMS-1600-FC 659

the risks of research participation without the benefit of producing generalizable knowledge applicable to the Medicare program. We be lieve that this criterion reflects a fundamental principle of research and does not require someth ing that would otherwise be absent from a bona fide clinical study prot ocol. Therefore, we are finaliz ing this criterion as proposed.

Comment : One commenter suggested that for proposed criterion 6 (the study is in compliance with all applicable Federal regulation s concerning the protection of human subjects found at 45 CFR part 46) that we also require compliance with FDA regulations at 21 CFR 50 (Informed Consent) and 21 CFR 56 (Institutiona l Review Board oversight) since 45 CFR 46 only refers to government funded research. Response : We agree with the commenter’s sugges tions and are modify ing this criterion in this final rule to require th at the study is in compliance with all applicable Federal regulations concerning the protection of hu man subjects found at 21 CFR parts 50, 56, and 812, and 45 CFR part 46.

Comment: Commenters recommended that we dele te the reference to the International

Committee of Medical Journal Edit ors in proposed criterion 7 (a ll aspects of the study are conducted according to appropriate standards of scien tific integrity set by the International

Committee of Medical Journal Editors. Response : In response to the comments received, we are removing proposed criterion 7. We believe that the intent of proposed criter ion 7 can be largely accomplished by adherence to the remaining CMS ID E study criteria. We are also removing proposed criterion 8 (the study has a wr itten protocol that clearly

demonstrates adherence to the standards listed he re as Medicare requirements) because the intent of proposed criterion 8 is implicit in the CM S coverage criteria and requirements.

Comment: One commenter suggested that propos ed criterion 9 (where appropriate, the

### CMS-1600-FC 660

clinical research study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Trials of a ll medical technologies measuring therapeutic outcom es as one of the objectives may be exempt from this standard only if the dis ease or condition being studied is life threatening and the patient has no other vi able treatment options), since the commenter believed that Medicare would only be furnis hing coverage for “conventional” care. Response : As discussed in the preamble to the proposed rule, the inte nt of this criterion is to limit Medicare coverage to IDE studies th at do not exclusively test toxicity or disease pathophysiology in healthy individu als, but also have a therapeu tic outcome. However, a study that exclusively te sts toxicity or disease pa thophysiology may still be co vered if the disease or condition being studied is life-threatening or a seve rely-debilitating illness, and the patient has no other viable treatment options. We recognize that many research projects could be considered to have varying degrees of contributions towards u nderstanding intervention s that improve health outcomes for the Medicare program. While we ag ree that in some cases, safety and toxicity studies may assess the benefits of the interventions they examine, and in limited circumstances may be considered appropriate to inform the clin ical knowledge base applicable to the Medicare program, we are maintaining this criterion without change.

Comment : Commenters expressed interest in the possible impact of the rule on ClinicalTrials.gov reporting, and suggested that we require that proposed criterion 10 (the study is registered on the ClinicalTrials.gov website and/ or the Registry of Patient Registries (RoPR) by the principal sponsor/investigator prior to the enrollment of th e first study subject) comply with section 801 of the Food and Drug Admi nistration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85, enacted on September 27, 2007), which requires registration on ClinicalTrials.gov within 21 days of enrollment of the first subject. Response : As discussed in the preamble to the proposed rule, we believe that all studies

### CMS-1600-FC 661

seeking Medicare coverage under this policy shou ld be registered with ClinicalTrials.gov. Registrants at ClinicalTrials.gov must submit a standa rdized set of data elements to describe the study design, eligible populati ons, outcome measures, and other parameters and results. Registration, for some studies, serves as a vehicl e for Medicare beneficiaries to learn about, and identify studies in which they may want to partic ipate. When results reporting is required, it also offers an assurance of quality because, genera lly, public access to information enables a higher level of accountability in the accura te reporting of the clinical study protocol and results, and in

the conduct of the trial itself. This accountabil ity derives both from public access to information about studies and from the risk of penalty fo r submitting false or misleading clinical trial information. We recognize that, for some studi es of unapproved devices, FDAAA prohibits the public display of information on registration and results until after the device is approved or cleared for marketing. We have revised our regulation to avoid indicating that Medicare coverage of such IDE studies would requi re public display of all information in ClinicalTrials.gov for these unapprov ed devices. However, we beli eve that delayed display for this subset of studies, should the device be cleared or approved for marketing, will not significantly undermine our goals. For some studies, we expect public access to ClinicalTrials.gov data will not be delayed and th erefore our requirement will immediately lead to greater public transp arency for many of the studies supported by Medicare. For those studies about which information cannot be displayed public ly prior to marketing approval, we believe that the possibility of future publ ic access and the risk of liability for the submission of false or misleading clinical trial information to Clinic alTrials.gov remain valuable. Registration with ClinicalTrials.gov also assures that Medicare beneficiaries and th eir treating healthcare professionals will, for those devices ultimately approved or cleared by FDA, eventually have pertinent information about these IDE studies. We not e that clinical trials of devices that register

### CMS-1600-FC 662

for purposes of this regulation are subject to any applicable requirements under FDAAA. Finally, we have modified the criteria to simply require registration on Cl inicalTrials.gov.

Comment : In summary, proposed criterion 11 stated that the study protocol must specify the method and timing of public release of re sults on all pre-specified outcomes, including release of negative outcomes. On e commenter stated that time to publication may not be in the control of the sponsors and that some studies ma y not be published at all for various reasons. Commenters suggested that we modify this crite rion to be consistent with section 801 of the

FDAAA. Response : Based on the comments received, we are modifying this criterion to state that the study protocol describes the method and timing of release of results on all pre-specified outcomes, including release of negative outcomes a nd that the release should be hastened if the study is terminated early.

Comment: In summary, proposed criteria 12 and 13 stated that the study protocol must explicitly discuss the subpopulations affected by the items or services under investigation and discuss how the study results would be expected to be generalizable to the Medicare population. Commenters believed that explicitly requiring this information in the study protocol was inappropriate, with other comment ers indicating that this inform ation could be provided in the request for coverage submission package versus explicitly requiring it in the study protocol. A commenter stated that generalizability to populat ions beyond those which ar e studied in the trial may be difficult to articulate, especially when the class of device is new. Commenters opined

that if the device class is th e subject of a Medicare national or local coverage decision, the

criterion is redundant and ma y create undue burden on a trial being conducted in a least

burdensome environment. One commenter suggested that for devices that represent a device improvement, the

### CMS-1600-FC 663

existing body of knowledge and other supporting docum ents will likely address sub- and special populations. The commenter also stated that fo r truly new devices, safety and efficacy at a baseline level are not yet established and that a mandate to include special populations and under-represented groups is likely to be pr ohibitive to completi on of the trial. Response : We want to support and encourage the conduct of research studies that add to the knowledge base about efficient, appropriate, and effective use of products and technologies in the Medicare population, thus improving the qu ality of care that Me dicare beneficiaries

receive. We understand the commenters’ concer ns; however, we expect that the results of studies or trials approved for purposes of Medicare coverage will specifically benefit the Medicare population.

It is not our intention to re quire enrollment of all subpopulations. It is, however, our intention that study protocols fo r which Medicare coverage is sought address all populations affected by the technology under in vestigation, specifically those of interest to the Medicare program (populations due to age, disability, or othe r eligibility status). We expect that protocols describe the potential for subgroup differences and discuss how the study will evaluate any

differences found. In this final rule, we are combining and m odifying proposed criteria 11 and 12 to state that for purposes of Medicare coverage, Cate gory A or Category B ID E study protocols must

discuss how Medicare beneficiar ies may be affected by the de vice under investigation, how the study results are or are not expected to be gene ralizable to the Medica re population, and must include separate discussions for populations eligible for Medicare due to age, disability, or other eligibility status.

Comment : Commenters suggested that we re move the proposed Medicare coverage requirements that a Category A or B IDE study must be a pivotal study and have a superiority

### CMS-1600-FC 664

study design. Commenters expre ssed concern that noninferiority studies were not specifically

discussed. One commenter recommended that IDE studies conducted as part of the FDA premarket approval (PMA) process be deemed as meeting the pivotal tr ial definition and be eligible for automatic coverage. Commenters st ated that noninferior ity studies and studies without an active comparator are designed to addr ess important research questions and ultimately improve patient care, and cited the following concerns about including this requirement:

● Requiring that the stu dy be either a superiority or pivotal study may undermine

innovation.

● Not all clinical questions require superiority designs.

● Development of devices that are simila r to devices already on the market may only require evidence of equivalence or noninferior ity to a preexisting device while offering an expanded treatment option and lower healthcare costs through competition in the market.

● Medical device development may follow less well-defined paths of clinical study with

individual studies not always easily characterized by a sp ecific Phase, but still providing important evidence on a device's safety and effectiveness.

● In many cases, the protocol is not changed between the pilot and pivotal phases and including this requirement may make studies in the pilot phase ineligible for coverage.

● Investigator-initiat ed studies often evaluate novel a pproaches in small studies and are unlikely to be pivotal. Response : We appreciate the commenters’ conc erns about the propos ed pivotal study and superiority study design Medicar e coverage criteria. We belie ve that noninferiority trial designs are recognized to have certa in risks of bias that are mitiga ted in superiority trial designs. These criteria were intended as sp ecific positive factors that could have streamlined the Medicare coverage review of IDE study protocols. We did not intend that th ese proposals would be

### CMS-1600-FC 665

absolute requirements or that IDE studies that are not pivotal or studi es with noninferiority designs could not be approved for Medicare c overage. Therefore, we are modifying the Medicare coverage IDE study criteria in new §405.212 by removi ng the proposed pivotal study and superiority study design coverage requireme nts and removing the proposed definitions of pivotal studies or trials and superiority studies or trials in revised §405.201(b).

d. Additional issues

Comment : Commenters stated that submitting I RB letters for every site involved in a multi-site clinical trial would create significant bu rden for stakeholders and is duplicative of the FDA’s review process. Response : We believe that Medicare beneficiaries should be enroll ed in studies that have been vetted by IRBs. However, we recognize commenters’ concerns regarding the potential burden of submitting IRB letters for every site involve d in a multi-site clinical trial. Therefore, we are clarifying in this final rule that interested parties, such as the study sponsor, that wish to seek Medicare coverage rela ted to Category A or B IDE st udies need only submit one IRB approval letter with their request.

Comment: Commenters requested assurance th at information provided by the study sponsor will be kept confidential. Response: Seeking Medicare coverage for Cate gory A or B IDE trials is voluntary. Medicare coverage is not a requirement for study sponsors to conduct research. Effective January 1, 2015, interested part ies (such as the study sponsor) that wish to seek Medicare coverage in Category A or B ID E studies must submit a request to CMS for review and approval of a Category A or B IDE study in order to meet the Medicare cove rage requirements for Category A or B IDE routine care items and services, and Category B devices. Upon CMS approval of a Cate gory A or B IDE study, we will post on the CMS website

### CMS-1600-FC 666

and periodically in the Federal Register limited information supplied by the interested party as part of their Medicare cove rage IDE study review request (study title, sponsor name, NCT number, and the IDE number), along with the CMS a pproval date. We note that the same type of information is currently posted on the CMS website for other clinical stud y approvals related to Medicare coverage under the co verage with eviden ce development (CED) paradigm. We note that we did not propose any changes to §405.215, which addresses confidential commercial and trade secret information by specifying that, to the extent that we rely on confidential commercial or trade secret information in any judicial pro ceeding, we will maintain c onfidentiality of the of

the information in accordance with Federal law.

Comment : Commenters requested informati on about appropriate procedures for notification of trial revisions, pr otocol changes, and review of consent forms. One commenter requested that we align with the ClinicalTrials.g ov registry, so that spon sors and researchers can provide updates to both systems. Other commenters suggested that instead of notifying the public of CMS-approved IDE studies in the Federal Register , that we post this information to

the CMS website. Response : We do not believe that the creation of a shared registry with the National Library of Medicine’s Clinic alTrials.gov registry to include information regarding CMS approval of Category A or B IDE studies could be accomplished before the effective date of this regulation. As previously discussed, limited information regarding CMS-approved Category A and B IDE studies will be posted on the CMS website and in the Federal Register

. Comment : A few commenters asked how the proposed changes to the coverage requirements would impact or interact w ith the NCD process, including CED. Response : Medicare coverage of Category A ID E routine care items and services, and Medicare coverage of Category B IDE devices an d routine care items and services do not predict

### CMS-1600-FC 667

nor directly lead to Medicare coverage outside of the cont ext of an IDE study, nor does it necessarily lead to consideration under the Me dicare national coverage determination (NCD) process. The NCD process is separate and distinct with its own statutory basis and requirements. Additional information regarding the Medicare na tional coverage determination process can be found on the CMS coverage website at http://www.cms.gov/Center/S pecial-Topic/MedicareCoverage-Center.html?redirect=/center/coverage.asp

. Comment : Commenters requested clarification about Medicare cove rage of Category A

IDE related routine care items a nd services and Category B IDE de vices and related routine care items and services, when the Medicare beneficiary is enrolled in a Medicare Advantage plan or Medicare health plan. Response : Medicare Advantage plans must ab ide by the IDE study payment policy as

instructed in the Medicar e Managed Care Manual, Ch apter 4, Section 10.7.2. 4. Summary of Changes to Proposed Provisions As a result of the comments received, we are ma king the following changes in this final rule.

● For the purpose of clarity, we are modify ing the following definitions to state:

++ Category B (Nonexperimental/investigational) device refers to a device for which the incremental risk is the primary risk in que stion (that is, initial que stions of safety and effectiveness of that device type have been resolv ed), or it is known that the device type can be safe and effective because, for example, ot her manufacturers have obtaind FDA premarket approval or clearance for that device type.

++ Routine care items and services refers to items and services that are otherwise generally available to Medicare beneficiaries (that is, a benefici ary category exists, it is not statutorily excluded, and there is no national noncoverage decision ) that are furnished during a clinical study and that would be otherwise furnished even if the be neficiary were not enrolled in

### CMS-1600-FC 668

a clinical study.

● We are revising §405.207(b)(3 ) to state “Routine care items and services related to Category A (Experimental) de vices as defined in §405.211.”

● We are revising §405.207(b)(3 ) to state “Routine care items and services related to Category B (Nonexperimental/inves tigational) devices as define d in §405.201(b), and furnished in conjunction with FDA-approved clinical studies that meet the coverage requirements in §405.211.”

● We are modifying §405.211 so that—

++ Medicare covers routine care items a nd services furnished in an FDA-approved Category A IDE study if CMS (or its designated enti ty) determines that the Medicare coverage IDE study criteria in §405.212 are met. ++ Medicare may make payment for a Cate gory B (Nonexperimental/investigational)

IDE device and routine care items and services furnished in an FDA-approved Category B (Nonexperimental/investigational) IDE study if CM S (or its designated entity) determines that the Medicare coverage IDE study criteria in §405.212 are met. ++ CMS (or its designated entity) must review the following to determine if the Medicare coverage IDE study cr iteria in §405.212 are met (that is , FDA approval letter of the IDE, IDE study protocol, IRB approval letter, NCT number, and suppor ting materials, if needed). ++ A listing of all CMS-approved Category A IDE studies and Ca tegory B IDE studies shall be posted on the CMS website and published in the Federal Register.

● We modified new §405.212 (IDE study criteria) to require that, for Medicare coverage of items and services described in §405.211, a Category A (Experimental) or Category B (Nonexperimental/investigational) IDE study must meet all of the following criteria.

### CMS-1600-FC 669

++ The principal purpose of the study is to test whethe r the device improves health outcomes of appropriately selected patients. ++ The rationale for the study is well s upported by available scientific and medical information or it is intended to clarify or establ ish the health outcomes of interventions already in

common clinical use. ++ The study results are not anticipated to unjustifiably duplicat e existing knowledge. ++ The study design is methodologically appr opriate and the antic ipated number of enrolled subjects is adequate to confidently answ er the research question(s) being asked in the study. ++ The study is sponsored by an organizati on or individual capa ble of successfully completing the study. ++ The study is in compliance with all applicable Federal regulations concerning the protection of human subjects found at 21 CF R parts 50, 56, and 812, and 45 CFR part 46. ++ Where appropriate, the study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Studi es of all medical technologies measuring therapeutic outcomes as one of the objectives ma y be exempt from this criterion only if the disease or condition being studied is life threatening and the patient has no other viable treatment options. ++ The study is registered with the Nationa l Institutes of Health’s National Library of Medicine’s ClinicalTrials.gov. ++ The study protocol describes the method and timing of release of results on all prespecified outcomes, including re lease of negative outcomes and that the release should be hastened if the study is terminated early. ++ The study protocol must describe how Me dicare beneficiaries may be affected by the

### CMS-1600-FC 670

device under investigation, and how the study results are or are not expected to be generalizable to the Medicare beneficiary popul ation. Generalizability to popul ations eligible for Medicare due to age, disability, or other eligibility status must be explicitly described. We are also making the following conformi ng changes to 42 CFR 405 subpart B.

● To reflect changes in §405.201(b), we are making conforming changes to the following sections: §40 5.201(a)(2); §405.203(a)(1) and (a )(2); §405.203(b); §405.205(a)(1); §405.209; §405.213(a)(1); and §411.15(o)(1), by replaci ng the term experimental/investigational (Category A) device with Category A (E xperimental) device, and the term Nonexperimental/investigational (Category B) device with Category B (Nonexperimental/investigational) device, as applicable.

● In §405.201(b), we are changing the term IDE to investigational device exemption (IDE) for clarity purposes.

● In §405.207(b)(2), we are making confor ming changes to reflect changes to the definitions in §405.201(b) and revised §405.211.

● In §411.15(o)(2), we are making conf orming changes to reflect revised §405.211.

### CMS-1600-FC 671

B. Ultrasound Screening for Abdominal Aortic Aneurysms 1. Background and Statutory Authority Section 1861(s)(2)(AA) of the Act authorizes Medicare coverage unde r Part B of ultrasound screening for abdominal aortic aneurysms (“AAA screeni ng”), as defined in section 1861(bbb) of the Act. Our implementing regulations for AAA screening ar e at §410.19. AAA screening is covered for a beneficiary that meets certain criteria including that he or she must receive a referral during the initial preventive physical examination (IPPE) and has not previously had an AAA screening covered under the Medicare program. The IPPE, as described in section 1861(ww) of the Act (and regulations at §410.16),

includes a time restriction and must be furnished not more than 1 year after the effective date of the beneficiary’s first Part B coverage period (see secti on 1862(a)(1)(K) of the Act). This time limitation for the IPPE effectively reduces a Medicare beneficiar y’s ability to obtain a referral for AAA screening. Section 1834(n) of the Act, added by section 4 105 of the Affordable Care Act, grants the Secretary the discretion and authority to modify c overage of certain preventive services identified in section 1861(ddd)(3) of the Act, which in turn cross-re ferences section 1861(ww)(2) of the Act (including AAA screening at section 1861(ww)(2)(L)). The Secretary may modify coverage to the extent that such

modification is consistent with the recommendations of the United States Preven tive Services Task Force (USPSTF) per section 1834(n)(1)(A) of the Act. In 2005, the USPSTF recommended “one-time screening for [AAA] by ultrasonography in men aged 65 through 75 who have ever smoked. (Grade: B Recommendation)” (Screening for Abdominal Aortic Aneurysm: Recommendation Statement. http://www.uspreventiveservicestaskfo rce.org/uspstf05/aaascr/aaars.htm ). The USPSTF recommendation does not include a time limit with resp ect to the referral for this test. 2. Provisions of the Regulations for Final Rule with Comment Period We proposed to exercise our discretion and auth ority under section 1834(n) of the Act to modify coverage of AAA screening consistent with the r ecommendations of the USPSTF to eliminate the oneyear time limit with respect to the referral for this service. This modification will allow coverage of AAA screening for eligible beneficiaries without requiring th em to receive a referral as part of the IPPE.

### CMS-1600-FC 672

Specifically for purposes of coverage of AAA screeni ng, we proposed to modify the definition of “eligible beneficiary” in §410.19(a) by removing paragr aph (1) of the definition of “eligible beneficiary” and redesignating paragraphs (2) and (3) of the defini tion of “eligible beneficiary” as paragraphs (1) and (2), respectively.

The IPPE is a one-time benefit available to beneficiaries under Part B that receive the IPPE not more than 1 year after the effective date of the bene ficiary’s first Medicare Part B coverage period. Many beneficiaries were either not eligible to receive an IPPE (which did not become effective until January 1, 2005) or may not have taken advantage of the IPPE wh en they were eligible, which limited beneficiary access to coverage of AAA screening. We believe th at our modification is consistent with current USPSTF recommendations for one-time screening and a llows for expanded access to this important preventive service. We received 12 public comments from various entiti es including physician specialty societies, a manufacturer and a manufacturer advocacy group, a be neficiary advocacy organization, a medical group management association, and a health insurer. A ll of the comments supported our proposal to modify coverage of AAA screening to eliminate the one-year time limit with respect to the referral for this service. Below is a summary of comments received and our response.

Comment : Two commenters believed that the propo sed modification to eliminate the one-year time limit with respect to the referral for AAA scr eening would only apply to men aged 65-75 who are smokers, and that individuals with a family history would continue to be required to receive a referral from the IPPE in order to be eligible for coverage of AAA screening. Response : This modification eliminates the one-year time limit with respect to referral for this service and allows coverage of AAA screening for all be neficiaries that meet the eligibility requirements for this benefit without requiring them to receive a re ferral as part of the IPPE. An eligible beneficiary, for purposes of this covered service, is an i ndividual that meets the following criteria:

● Has not been previously furnished AAA screening under the Medicare program; and

### CMS-1600-FC 673

● Is included in at least one of the following ri sk categories: (1) has a family history of an abdominal aortic aneurysm; or (2) is a man aged 65 to 75 who has smoked at least 100 cigarettes in his

lifetime. After taking into consideration the public comme nts received, we are finalizing this policy as proposed. C. Colorectal Cancer Screening: Modification to Coverage of Screening Fecal Occult Blood Tests 1. Background and Statutory Authority Sections 1861(s)(2)(R) and 1861(pp)(1) of the Ac t authorize Medicare coverage of colorectal cancer screening. The statute authorizes coverage of screening fecal occult blood tests (FOBT), screening flexible sigmoidoscopies, screening colonoscopies, and other tests determined to be appropriate, subject to certain frequency and payment limits. Our implemen ting regulations are codified at §410.37. Section 410.37(b) (condition for cove rage of screening FOBT) specifies that Medicare Part B pays for screening FOBT if ordered in writing by the beneficiary’s a ttending physician. For purposes of §410.37, “attending physician” is defined as “a doctor of medicine or os teopathy (as defined in section 1861(r)(1) of the Act) who is fully knowledgeable about the beneficiary’s medical condition, and who would be responsible using the results of any examinati on performed in the overall manageme nt of the beneficiary’s specific medical problem.” The coverage provisions for FOBT screening we re established in 1997 and effective on January 1, 1998 (62 FR 59048, October 31, 1997). In the preamble to that final rule, we stated that the requirement for a written order from the attending physician was intended to make certain that beneficiaries receive appropriate preventive counselin g about the implications and possible results of having these examinations performed (62 FR 59081). Since then, Medicare coverage of preventive services has expanded to include, among other things, coverage of an annual wellness visit (as de fined in §410.15). The annual wellness visit includes provisions for furnishing personalized health advice and appropriate referrals. In addition to physicians,

### CMS-1600-FC 674

the annual wellness visit can be furnished by certa in nonphysician practitione rs, including physician assistants, nurse practitioners, and clinical nurse specialists. We also note that §410.32, which provides coverage and payment rules for diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests, states in subsection (a)(2): “Nonphysician practitioners (that is, clinical nurse specialists, clini cal psychologists, clinical social workers, nursemidwives, nurse practitioners, and physician assistants ) who furnish services that would be physician services if furnished by a physician, and who are opera ting within the scope of their authority under State law and within the scope of their Medicare statutor y benefit, may be treated the same as physicians treating beneficiaries for the purpose of this paragraph.” 2. Provisions of the Regulations for Final Rule with Comment Period We proposed to revise §410.37(b), “Condition for coverage of screening fecal-occult blood tests,” to allow an attending physician, physician assistant, nurse practitioner, or clinical nurse specialist to furnish written orders for screening FOBT. These m odifications will allow fo r expanded coverage and access to screening FOBT, particularly in rural areas. We received 8 public comments from various entities including physician and practitioner specialty societies, a pharmaceutical manufacturer, a beneficiary advocacy organization, a medical center, and a health insurer. All of the commenters supporte d our proposal to expand the types of practitioners

that are able to furnish written orders for screen ing FOBT, in addition to a beneficiary’s attending physician. Additionally, we inv ited public comment regarding whethe r a practitioner permitted to order a screening FOBT must be the beneficiary’s attendi ng practitioner as described earlier. Below is a summary of the comments received and our response.

Comment : One commenter suggested that the practiti oners ordering the test function under the direct and responsible supervision of a practicing, licensed physician. Another commenter thought that the qualified practitioner furnishing the order should be knowledgeable about the patient and their plan of care. One commenter opined that the limitation of orders from the attending practitioner should be removed to prevent unnecessary office visits with the pa tient, scheduled solely to demonstrate compliance

### CMS-1600-FC 675

with a requirement that the test results be used in the practitioner’s management of the patient’s condition. The same commenter suggested that decisions regarding the medical necessity of follow-up care be left to the clinical judgment of the practitioner. Response : After considering the public comments, we are retaining the “attending” requirement that provides assurance that the non-physician practiti oner will be knowledgeable about the patient and the patient’s plan of care. We are not requiring that these practitioners act only under the direct supervision of a practicing licensed physician as we view this suggestion as contrary to our goal of increasing access to this screening test, particularly in rural areas. Our expansion of coverage of screening FOBT to include tests ordered by an attendi ng physician assistant, nurse practitioner, or clinical nurse specialist are consistent with the requireme nts for tests ordered for diagnostic purposes where nonphysician practitioners may be treated the same as physicians treating beneficiaries. The attending practitioner (physician, physician assistant, nurse practitioner, or clinical nurse specialist) would be responsible for using the results of the screening t est in the overall management of the beneficiary’s

medical care. We leave it to the discretion of the attending practitioner to determine what follow-up care may be necessary. After consideration of the public comments received, we are implementing this policy as proposed.

### CMS-1600-FC 676

D. Ambulance Fee Schedule 1. Amendment to Section 1834(l)(13) of the Act Section 146(a) of the Medicare Improvements for Patients and Providers Act of 2008 (Pub. L. 110-275, enacted on July 15, 2008) (MIPPA) amended section 1834(l)(13)(A) of the Act to specify that, effective for ground ambulance services furnished on or after July 1, 2008 and before January 1, 2010, the ambulance fee schedule amounts for ground ambul ance services shall be increased as follows:

● For covered ground ambulance transports that orig inate in a rural area or in a rural census tract of a metropolitan statistical area, the fee schedul e amounts shall be increased by 3 percent.

● For covered ground ambulance transports that do not originate in a rural area or in a rural census tract of a metropolitan statistical area, the f ee schedule amounts shall be increased by 2 percent. Sections 3105(a) and 10311(a) of the A ffordable Care Act further amended section 1834(l)(13)(A) of the Act to extend the payment add-ons described above for an additional year, such that these add-ons also applied to covered ground ambulance tr ansports furnished on or after January 1, 2010, and before January 1, 2011. In the CY 2011 PFS fi nal rule with comment pe riod (75 FR 73385, 73386, 73625), we revised §414.610(c)(1)(ii) to conform the regulations to this statutory requirement. Section 106(a) of the Medicare and Medicaid Ex tenders Act of 2010 (Pub. L.111-309, enacted December 15, 2010) (MMEA) again amended section 1834(l)(13)(A) of the Act to extend the payment add-ons described above for an additional year, such that these add-ons also applied to covered ground ambulance transports furnished on or after January 1, 2011, and before January 1, 2012. In the CY 2012 End-Stage Renal Disease Prospective Payment Syst em (ESRD PPS) final rule (76 FR 70228, 70284 through 70285, and 70315), we revised §414.610(c)(1)(ii) to conform the regulations to this statutory requirement. Section 306(a) of the Temporary Payroll Tax Cu t Continuation Act of 2011 (TPTCA) (Pub. L. 112-78, enacted on December 23, 2011) amended section 1834(l)(13)(A) of the Act to extend the payment add-ons described above through February 29, 2012; and section 3007(a) of the Middle Class Tax Relief and Job Creation Act of 2012 (Pub. L. 112-96, enacted on February 22, 2012) (MCTRJCA)

### CMS-1600-FC 677

further amended section 1834(l)(13)(A) of the Act to extend these payment add-ons through December 31, 2012. Thus, these payment add-ons also applied to covered ground ambulance transports furnished on or after January 1, 2012 and befo re January 1, 2013. In the CY 2013 PFS final rule (77 FR 69139, 69368), we revised §414.610(c)(1)(ii) to conform the regulations to this statutory requirement. Subsequently, section 604(a) of the ATRA amende d section 1834(l)(13)(A) of the Act to extend the payment add-ons described above through Decemb er 31, 2013. Thus, these payment add-ons also apply to covered ground ambulance tr ansports furnished on or after Janua ry 1, 2013 and before January 1, 2014. In the proposed rule, we proposed to revise §414. 610(c)(1)(ii) to conform the regulations to this statutory requirement. We did not receive any comments on this proposal. Accordingly, we are finalizing our proposal to revise §414.610(c)(1)(ii) to c onform the regulations to the statutory requirement

described above. This statutory requirement is self-implementing. A plain reading of the statute requires only a ministerial application of the mandated rate increa se, and does not require any substantive exercise of discretion on the part of the Secretary. 2. Amendment to Section 146(b)(1) of MIPPA Section 146(b)(1) of MIPPA ame nded the designation of certain rural areas for payment of air ambulance services. This section originally specified that any area that was desi gnated as a rural area for purposes of making payments under the ambulance fee schedule for air ambulance services furnished on December 31, 2006, must continue to be treated as a rural area for purposes of making payments under the ambulance fee schedule for air ambulance services furnished during the period July 1, 2008 through December 31, 2009. Sections 3105(b) and 10311(b) of the Affordab le Care Act amended section 146(b)(1) of MIPPA to extend this provision for an additional year, th rough December 31, 2010. In the CY 2011 PFS final rule (75 FR 73385, 73386, and 73625 through 73626), we revised §414.610(h) to conform the regulations to this statutory requirement.

### CMS-1600-FC 678

Section 106(b) of the MMEA amended section 146(b)(1) of MIPPA to extend this provision again through December 31, 2011. In the CY 2012 ESRD PPS final rule (76 FR 70284, 70285, and 70315), we revised §414.610(h) to conform the re gulations to this statutory requirement. Subsequently, section 306(b) of the TPTCCA amended section 146(b)(1) of MIPPA to extend this provision through February 29, 2012; and sec tion 3007(b) of the MCTRJCA further amended section 146(b)(1) of MIPPA to extend this provision through D ecember 31, 2012. In the CY 2013 PFS final rule (77 FR 69139, 69140, and 69368), we revised §414.610(h) to conform the regulations to this statutory requirement. Subsequently, section 604(b) of the ATRA ame nded section 146(b)(1) of MIPPA to extend this provision through June 30, 2013. Thus, we proposed to revise §414.610(h) to conform the regulations to this statutory requirement. We did not receive any comments on this proposal. Therefore, we are finalizing our proposal to revise §414.610(h) to confor m the regulations to the statutory requirement

described above. This statutory requirement is self-implementing. A plain reading of the statute requires only a ministerial application of a rural indicator, and does not require any substantive exercise of discretion on the part of the Secretary. Accordingly, for areas th at were designated as rural on December 31, 2006, and were subsequently re-designated as urban, we re-estab lished the “rural” indicator on the ZIP Code file for air ambulance services through June 30, 2013. 3. Amendment to Section 1834(l)(12) of the Act Section 414 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (Pub. L. 108-173, enacted on December 8, 2003) (M MA) added section 1834(l)(12) to the Act, which specified that in the case of ground ambulance services furnished on or after July 1, 2004, and before January 1, 2010, for which transportation originates in a qualified rural area (as described in the statute), the Secretary shall provide for a percent increase in th e base rate of the fee schedule for such transports. The statute requires this percent increase to be based on the Secretary’s estimate of the average cost per trip for such services (not taking into account mil eage) in the lowest quartile of all rural county

### CMS-1600-FC 679

populations as compared to the average cost per trip fo r such services (not taking into account mileage) in the highest quartile of rural county populations. Us ing the methodology specified in the July 1, 2004 interim final rule (69 FR 40288), we determined that th is percent increase was equal to 22.6 percent. As required by the MMA, this payment increase was applie d to ground ambulance transports that originated in a “qualified rural area”; that is, to transports th at originated in a rural area included in those areas comprising the lowest 25th percentile of all rural popu lations arrayed by population density. For this purpose, rural areas included Goldsmith ar eas (a type of rural census tract). Sections 3105(c) and 10311(c) of the Affordab le Care Act amended section 1834(l)(12)(A) of the Act to extend this rural bonus for an additional y ear through December 31, 2010. In the CY 2011 PFS final rule with comment period (75 FR 73385, 7 3386 and 73625), we revised §414.610(c)(5)(ii) to conform the regulations to this statutory requirement. Section 106(c) of the MMEA amended section 183 4(l)(12)(A) of the Act to extend the rural bonus described above for an additional year, throug h December 31, 2011. Therefore, in the CY 2012 ESRD PPS final rule (76 FR 70284, 70285 and 70315), we revised §414 .610(c)(5)(ii) to conform the regulations to this statutory requirement. Section 306(c) of the TPTCCA amended section 1834( l)(12)(A) of the Act to extend this rural bonus through February 29, 2012; and section 3007( c) of the MCTRJCA further amended section 1834(l)(12)(A) of the Act to extend this rural bonus through December 31, 2012. In the CY 2013 PFS final rule with comment period (77 FR 69140, 693 68), we revised §414.610(c)(5)(ii) to conform the regulations to these statutory requirements. Subsequently, section 604(c) of the ATRA ame nded section 1834(l)(12)(A) of the Act to extend this rural bonus through December 31, 2013. Therefore, we are continuing to apply the 22.6 percent rural bonus described above (in the same manner as in pr evious years), to ground ambulance services with dates of service on or after January 1, 2013 and before January 1, 2014 where transportation originates in a qualified rural area.

### CMS-1600-FC 680

This rural bonus is sometimes referred to as the “Super Rural Bonus” and the qualified rural areas (also known as “super rural” areas) are identified duri ng the claims adjudicative process via the use of a data field included on the CMS-supplied ZIP Code File. In the proposed rule, we proposed to revise §414.610(c)(5)(ii) to conform the regulations to the statutory requirement set forth at section 604(c) of th e ATRA. We did not receive any comments on this proposal. Accordingly, we are finalizing our propo sal to revise §414.610(c)(5)(ii) to conform the regulations to this statutory requirement. This statutory requirement is self-implementing. This provision requires a one-year extension of the rural bonus (which was previously established by the Secretary) through December 31, 2013, and does not require any substantive exercise of discretion on the part of the Secretary. 4. Addition of section 1834(l)(15) of the Act Section 637 of the ATRA, which added section 1834(l)(15) of the Act, specifies that the fee schedule amount otherwise applicable under the preced ing provisions of section 1834(l) of the Act shall be reduced by 10 percent for ambulance services furnis hed on or after October 1, 2013, consisting of nonemergency basic life support (BLS) services involving tr ansport of an individual with end-stage renal disease for renal dialysis services (as de scribed in section 1881(b)(14)(B) of the Act) furnished other than on an emergency basis by a provider of services or a renal dialysis facility. We proposed to revise §414.610 by adding paragraph (c)(8) to conform the regulations to this statutory requirement. We did not receive any comments on this proposal. Accordingly, we are finalizing our proposal to revise §414.610 by adding paragraph (c)(8) to conform the regulati ons to the statutory requirement described above. This statutory requirement is self-implementing. A plain reading of the statute requires only a ministerial application of the mandated rate decre ase, and does not require any substantive exercise of discretion on the part of the Secretary. Accordi ngly, for the ambulance services described in section 637 of the ATRA furnished on or after October 1, 2013, the fee schedule amount otherwise applicable (both base rate and mileage) is reduced by 10 percent. Fo r further information regard ing application of this mandated rate decrease, please see CR 8269.

### CMS-1600-FC 681

5. Studies of Ambulance Costs Section 604(d)(1) of the ATRA provides that the Secretary shall conduct the following studies: (A) A study that analyzes data on existing cost reports for ambulance services furnished by hospitals and critical access hospitals, including varia tion by characteristics of such providers of services, with a Report to Congress on such study due by October 1, 2013; and (B) A study of the feasibility of obtaining cost data on a periodic basis from all ambulance providers of services and suppliers for potential u se in examining the appropriateness of the Medicare add-on payments for ground ambulance services furnis hed under the fee schedule under section 1834(l) of the Act and in preparing for future reform of su ch payment system, with a Report to Congress due on such study by July 1, 2014. Further, in conducting the study under paragr aph (B) above, section 604(d)(2) of the ATRA directs the Secretary to:

● Consult with industry on the desi gn of such cost collection efforts;

● Explore the use of cost surveys and cost re ports to collect appropriate cost data and the periodicity of such cost data collection;

● Examine the feasibility of developing a standa rd cost reporting tool for providers of services and suppliers of ground ambulance services; and

● Examine the ability to furnish such cost data by various types of ambulance providers of services and suppliers, especially by rural and super-rural providers of services and suppliers. As noted above, in conducting the study unde r section 604(d)(1) of the ATRA described in paragraph (B) above, the Secretary is required to consult with industry on the design of such cost collection efforts (see section 604(d)(2)(A) of the ATRA ). We used the proposed rule as the instrument to collect information, comments, and ideas from the i ndustry on the design of such cost collection efforts as described above, and on the feasibility of obtaining cost data on a periodic basis from all ambulance providers of services and suppliers for potential u se in examining the appropriateness of the Medicare add-on payments for ground ambulance services furnis hed under the fee schedule under section 1834(l) of

### CMS-1600-FC 682

the Act and in preparing for future reform of such payment system. We therefore invited public comment on these issues as part of the study we are conducting under section 604(d)(1)(B) of the ATRA. Several organizations provide d detailed comments on the issues described above. We appreciate the commenters’ insights and suggestions. We will c onsider those comments as we perform the study required by section 604(d)(1)(B) of the ATRA and prepare the Report to Congress. E. Policies Regarding the Clinical Laboratory Fee Schedule 1. Background on the Clinical Laboratory Fee Schedule Under Medicare Part B, clinical diagnostic laborator y tests furnished on or after July 1, 1984, in a physician’s office, by an independent laboratory, or by a hospital laboratory for its outpatients and nonpatients are paid on the basis of the Clinical Laboratory Fee Schedule (CLFS), with certain exceptions. For each Healthcare Common Procedure Coding System (HCPCS) code, payment is the

lesser of:

● The amount of charges billed for the test;

● The fee schedule amount for the state or a local geographic area; or

● A national limitation amount (NLA) (see section 1833(a)(1)(D)(i), (a)(2)(D)(i), (h)(1), and (h)(4)(B) of the Act). The NLA for a clinical diagnostic laboratory test performed after December 31 , 1997 is equal to 74 percent of the median of all

fee schedules established for that test for that labor atory setting or 100 percent of such median in the case of a clinical diagnostic laboratory test performed on or after January 1, 2001 that the Secretary determines

is a new test for which no limitation amount has previously been established (see section 1833(h)(4)(B)(viii) of the Act). Currently, we update the CLFS amounts annually to reflect changes in the Consumer Price Index for all Urban Consumers (CPI-U) and apply a mu lti-factor productivity adjustment (see section 1833(h)(2)(A) of the Act). In the past, we also im plemented other adjustments or did not apply the change in the CPI-U to the CLFS for certain years in accordance with statutory mandates. We do not otherwise update or change the payment amounts for tests on the CLFS.

### CMS-1600-FC 683

For any clinical diagnostic laboratory tests where a new or substantially revised HCPCS code is assigned on or after January 1, 2005, we determin e the basis for, and amount of, payment for these clinical diagnostic laboratory tests (see section 183 3(h)(8) of the Act and §4 14.500 through §414.509). Once established, however, in most cases, we only have the opportunity to reconsider the basis and/or amount of payment for new tests for one additional year after the basis or payment is initially set. Once the reconsideration process is complete, payment is not further adjusted (except by a change in the CPI-U, the productivity adjustment, and any other adjustments required by statute), regardless of any shift in the actual costs incurred to perform the test.

This lack of an established mechanism to ad just payment amounts is unique among the Medicare payment schedules and systems. Generally, other fee schedules and prospective payment systems are evaluated each year to reflect the changing mix of services provided under that system or schedule and then the system or schedule is adjusted to maintain budget neutrality. Since there is currently no process to make such adjustments for the CLFS, payment amo unts are not changed despite changes in technology, which affect the cost of performing the tests. This potentially results in CMS not paying as accurately for these tests. As discussed in the CY 2014 PFS propo sed rule (78 FR 43350 thro ugh 43352), we proposed to implement a process to adjust payment amounts b ased on changes in technology. Below, we discuss our proposals regarding this process and, at the end of section III.E.2. of this final rule with comment period, respond to comments about our proposals and finalize our policies. 2. Policies Regarding Technological Changes Under Section 1833(h)(2)(A)(i) of the Act a. Background on Technological Changes As discussed in the CY 2014 PFS proposed rule (78 FR 43350 through 43351), there has been a significant amount of technological change in the clinical laboratory area since the implementation of the CLFS. This technological change has led to the in creased use of point-of-care testing, brand new tests being developed, and the prolifera tion of laboratory-developed tests. The Institute of Medicine (IOM) dedicated a chapter of its 2000 report “Medicare Labo ratory Payment Policy: Now and in the Future” to discussing trends in laboratory technology. The report noted rapid and dramatic innovation in the

### CMS-1600-FC 684

laboratory sector since the 1980s and remarkable growth in the range and complexity of available tests. The IOM concluded that the introduction of new tests, advances in equipment and testing techniques, and the proliferation of advanced information technology have all made testing more efficient and automated. Technology has enabled a significant site-of-service shift for many laboratory tests from the laboratory environment to the point of health care delivery. This poin t-of-care testing has increased since the 1980s, when this type of testing first became av ailable, mainly due to changes in technology which resulted in smaller, cheaper, and more portable test k its that are simple to use. For example, drug abuse testing has become readily available at the point-of- care. Point-of-care testing can be performed in various institutional and community settings but the ma in objective of such testing is to produce a result quickly, at the place where the patient is receiving care, such as at a physician’s office or at a hospital bedside, in order to facilitate deci sions about appropriate treatment. There also are brand new technologies that did no t exist when the CLFS was established, most notably the methods that are the basis for many genetic and genomic tests. Many of these methods evolved from the work of the Human Genome Project and subsequent research and development by both the federal government and private firms. The co st of sequencing a genome has dropped dramatically since the early inception of this technology in 2001 from more than $95 million per genome to approximately $5,700 in early 2013 ( http://www.genome.gov/pages/ der/sequencing_cost.xlsx ). Early tests in this area were less likely to be covered by Medicare because they were either screening tests or tests for conditions found largely in a pediatric population. As this area has expanded over the past several decades, Medicare has taken on a more prominen t role in payment for these services. We expect

the number of codes and tests in this area to conti nue to grow as the technology evolves and more tests become available in the areas of pharmacogenomi cs, personalized and predictive medicine, and companion diagnostics. Moreover, we expect the costs of these tests to change over time, and we believe that the CLFS ought to be able to better reflect these changes. We also note the growth in laboratory-developed tests (LDTs) over the years. These proprietary tests are developed by laboratories, which then offer the service of providing the test. Some of the most

### CMS-1600-FC 685

advanced laboratory tests currently being performed are LDTs which use sophisticated proprietary technology. Many LDTs do not have their own HC PCS codes; instead, they are billed using unlisted

codes for which Medicare Administrative Contractors (MACs) establish a payment amount for their local jurisdictions. Prior to 2012, other LDTs were billed to Medicare using “stacking codes,” where a laboratory submits a code for each step of the testi ng process. These “stacking codes” were eliminated at the end of 2012 and replaced with new test-specific codes. The use of unlisted CPT and “stacking” codes pr ovided us with limited information about the technology used to perform these tests. However, we know that the number of LDTs has been growing over the years. We also know that multiple laborator ies have developed different ways to perform the same test. Further, our recent experience with using a gapfilling methodology to price molecular pathology tests, which can be LDTs, has shown that the costs of performing these tests have decreased since contractors initially established payment amounts for the tests, or compared to the code stack previously billed. Our experience with gapfilling mol ecular pathology tests also has shown that there is wide variation in the cost of performing th e same test by different laboratories. We believe that, given the technological changes th at have occurred in the laboratory industry over the past several decades and the growth in the number of clinical laboratory tests (for example, we have added approximately 800 new test codes to the C LFS since its inception), it would be appropriate to establish a process to reexamine payment amounts on the CLFS to take into account increased efficiency, changes in laboratory personnel and supplies necessary to conduct a test, changes in sites of service, and other changes driven by technological advances. Section 1833(h)(2)(A)(i) of the Act requires the S ecretary to set the fee schedules for clinical laboratory tests “for the 12-month period beginning July 1, 1984, adjusted annually (to become effective on January 1 of each year) by, subject to [the multi -factor productivity adjustment], ... a percentage increase or decrease equal to the percentage increase or decrease in the [CPI-U], . . . and subject to such other adjustments as the Secretary determin es are justified by technological changes ” (emphasis added). Under this authority, in the CY 2014 PFS proposed rule (78 FR 43350 through 43352), we proposed a

### CMS-1600-FC 686

process under which we would systematically reex amine the payment amounts established under the CLFS to determine if changes in technology for the de livery of that service warrant an adjustment to the payment amount. b. Definition of Technological Changes In the CY 2014 PFS proposed rule (78 FR 43351), we proposed to define technological changes as changes to the tools, machines, supplies, labor, instruments, skills, techniques, and devices by which laboratory tests are produced and used. We stated th at changes in technology could result in changes to, among other things, the resources required to perform the test (such as the type, volume, or number of supplies or reagents required), the laboratory personnel required to perform the test, and/or the frequency of testing, volume of testing, or site of servi ce (for example, a shift in service site from a specialty laboratory to a physician’s office). We believe this broad definition would capture all of the technological changes that could impact the resource inputs for various tests on the CLFS. As we explained in the CY 2014 PFS proposed rule (78 FR 43351 and 43352) and as discussed below, the technological changes for a specific test would be discussed in the proposed rule in which we are proposing to adjust the payment amount for that test, and we would seek public comment on our determination of the technological changes and the proposed payment adjustment. We respond to any comments on the proposed definition at the end of secti on III.E.2. of this final rule with comment period.

c. The Process In the CY 2014 PFS proposed rule (78 FR 43351), we proposed that, each year, we would review certain codes on the CLFS, as described in the next section, to determine whether we believe that payment for these codes should be adjusted due to te chnological changes. For those codes where we determine that payment adjustments should be made , beginning with the CY 2015 PFS proposed rule (which will be promulgated during 2014 and any fina lized payment adjustments would affect payments beginning in CY 2015), we would identify the test code, discuss how it has been impacted by technological changes, and propose an associated adju stment to the payment amount for the test code as appropriate to reflect the impact of such technological changes.

### CMS-1600-FC 687

We believe such adjustments could be made both to increase fee schedule amounts (for example, in situations where new high cost technologies are em ployed), and to provide for reductions in existing amounts (for example in situations where technology reduces costs through increased efficiencies). We stated that we expect that most payment amounts w ould decrease due to the cha nges in technology that have occurred over the years since the payment am ounts were established and the general downward trend of costs once a new technology has had an opportunity to diffuse. A key goal in establishing this review process is to ensure payment accuracy after technological changes; thus, payment amounts could

increase or decrease as a result of these reviews. Under our proposed process, we would list c odes that we reviewed for which there was insufficient information to support or establish an adju stment to the payment amount due to technological changes. We also would solicit comment on the tec hnology used to perform any tests we reviewed for possible payment changes, and any relevant cost inform ation. We stated that we expect that we would finalize any payment adjustments in the PFS final rule during 2014, which would affect payments beginning in CY 2015. We proposed that the CPI-U and multi-factor productivity adjustments would be applied after we established the new payment amount through our usual instruction process. We believe that this proposed process would best allow for the greatest amount of transparency in review and the most structured and consistent opportunity for the public to provide input into the process. We solicited comment on these proposals. We respond to comments on this proposed process at the end of section III.E.2. of this final rule with comment period.

d. Identification and Prioritization of Codes to be Reviewed In the CY 2014 PFS proposed rule (78 FR 4335 1 through 43352), we proposed to review all codes currently on the CLFS. We proposed to star t our review by examining the payment amounts for codes that have been on the CLFS the longest and th en work our way forward, over multiple years, until

we have reviewed all of the codes on the CLFS. We believe that the payment amounts for codes that have been on the CLFS the longest amount of time w ould be most affected by changes in technology because, in general, technology is most expensive ear liest in its life cycle but decreases in cost as the

### CMS-1600-FC 688

technology matures and diffuses. If during the course of reviewing these individual codes we find that there are additional, newer codes that are clinically and/or technologically similar, we proposed to

consider them for review at the same time as we revi ew the older codes because we expect that we would have the same or similar justifications for making paym ent adjustments to those cod es. We stated that we intend to review these codes as quickly as possibl e but we believe there would be a significant administrative burden associated with such a comprehe nsive review of the approximately 1,250 codes on

the CLFS. We estimated that it would take at least 5 years to review all of the existing codes on the

CLFS. Once we completed our review of the codes currently on the CLFS and made any adjustments necessary due to technological changes, we proposed to review codes added to the CLFS after 2015 that have been on the CLFS for at least 5 years. We al so would review codes again that have not been reviewed in the previous 5 years, as time and resources allow. We believe that tests that are less than 5 years old are likely still in their technological in fancy and enough time w ould not have passed to adequately assess any change in technology for those servi ces. Similarly, for previously reviewed codes, we believe that technology likely woul d not have changed dramatically in less than 5 years. We solicited public comment on how to prioritize these codes, which we expect to address in future rulemaking on this

issue. After the initial review of the codes currently on th e CLFS, we also proposed to allow the public to nominate additional codes for review, including those that had been previously reviewed for technological change. We proposed that the public ma y nominate only codes that have been on the CLFS for at least 5 years and that have not been reviewed in the previous 5 years. Further, we proposed that the nomination must include an explanation from the nominator of the technological change in the service and the way that change affects its delivery. We would then consider these nominations and, in the Federal Register the following year, either propose a paymen t change based on technological changes or explain why we think such a change is not warranted at that time.

### CMS-1600-FC 689

We proposed to codify the proposed definition of technological changes and the process at §414.511. We solicited public comment on these proposals. We also solicited comment on alternative approaches to achieving our goal of paying appropriately for laboratory tests by accounting for changes in technology. Finally, we solicited comment on genera l trends in technology change in the laboratory industry and the health care sector in general. Th e following is a summary of the comments we received regarding our proposals for the CLFS in the CY 2014 PFS proposed rule:

Comment : Several commenters recommended that CM S reconsider its proposal to review and adjust CLFS payment amounts. Response : The existing payment amounts on the CLFS have not been changed since they were first implemented (excluding chang es for inflation and other statutory adjustments). In some cases, payment amounts have not changed for over 30 years (excluding changes for inflation and other statutory adjustments). Therefore, we believe it is necessary and important to review and adjust payment amounts based on technological changes for tests on the CLFS.

Comment : Several commenters were concerned ab out CMS developing a transparent process where the public, specifically laboratories, could par ticipate in determining which test codes on the CLFS to revisit for payment purposes and provide input on t echnological changes with respect to a code being reviewed for adjustment. These comme nters suggested that one solution might be some type of advisory committee made up of representatives from the laboratory indus try and organized by CMS. Response : We appreciate the comment and agree that the process to adjust payment amounts for tests on the CLFS based on technological changes shoul d be a transparent one. However, developing a formal advisory committee would be a time-consuming and resource intensive process. We believe that we can accomplish the same purpose by utilizing the annual rulemaking cycle, which includes a comment period where the public can provide information on how the technology for providing clinical diagnostic laboratory tests has changed over time and suggestio ns for data to support revised payment amounts on particular test codes.

### CMS-1600-FC 690

We agree that the public also should participat e in determining which test codes should be reviewed. We proposed that, after the initial review of all of the test codes currently on the CLFS concludes, the public could nominate codes for review that have been on the CLFS for at least 5 years and that have not been reviewed in the previous 5 years. We also proposed that the nomination must include an explanation from the nominator of the technologica l change in the service and the way that change affects its delivery. However, based on these comment s and upon further reflection, we are changing our proposal so that nominations are not limited to the tim e period after the initial review period or to certain types of test codes. Under our process, the public may nominate test codes that are on the CLFS for review during the public comment period to the proposed rule. As we proposed for situations where the public no minates test codes, the nominator must include an explanation of the technological change in the service and the way the change affects its delivery because this information will assist us in determining whether the test code should move forward through the payment adjustment process. In addition, we ar e changing our proposal to require the nominator to provide any relevant cost information, as well because this information will assist us in determining an appropriate payment should the test code move forw ard through the payment adjustment process. CMS will retain the final authority in determining which test codes move forward through the payment revision process because, for example, some test codes may be suggested which do not have enough supporting information to justify payment rate revisions based on changes in technology or more test codes may be suggested for payment rate revisions than can possi bly be addressed within one rulemaking cycle. For those codes identified by the public for revi ew where we determine that payment adjustments based on technological changes should be made, in th e following year’s proposed rule, we will identify the test code, discuss how it has been impacted by technological changes, and propose an associated adjustment to the payment amount for the test code as appropriate to reflect the impact of such technological changes. We also will list any test cod es that the public suggested for review but for which we are not proposing to move forward through the payment revision process and explain why we are not proposing any changes at that time. Finalized paymen t revisions would take effect the following January

### CMS-1600-FC 691

1. For example, test codes suggested during the comment period to the CY 2015 PFS proposed rule and agreed to by CMS for the payment revision process will be addressed through the CY 2016 PFS rulemaking process with finalized payment adjustments being effective January 1, 2016.

Comment : Several commenters, along with MedPAC, stated that, if CMS does implement changes in payment amounts for test codes on the CLFS, CMS should consider data from private insurers, federal insurers, and CMS contractors; however, some commenters suggested that contractor data not be

used. Response : It is our intention to consider data from all available sources in order to evaluate the impact of technological changes on payment amounts. We believe that this will promote fair and equitable fee schedules that reflect current and reasona ble payments for laboratory tests. Therefore, we plan to review all data that can be obtained from any source.

Comment : Some commenters, along with MedPAC, suggested that CMS focus on high dollar payments first, while other commenters recommended a focus on codes with rapid spending growth.

Some commenters recommended that a different time frame be implemented instead of the proposed one which limits the ability to review a test code until it has been on the CLFS for at least 5 years. These commenters also believe that it will take longer than 5 years to review all the test codes currently on the

CLFS. Response : In the CY 2014 PFS proposed rule (78 FR 43351 through 4335 2), we proposed to review all codes currently on the CLFS and we proposed to start our review by examining the payment

amounts for codes that have been on the CLFS the lo ngest and then work our way forward over multiple years until we reviewed all of the codes on the CLFS. We also proposed to review newer codes that were clinically and/or technologically similar to the cod es being reviewed. Once we had completed this initial review, which we estimated would take at least 5 y ears, we proposed to review codes added to the CLFS after 2015 that had been on the CLFS for at least 5 y ears and would review codes again that had not been reviewed in the previous 5 years, as time and resources allowed. Further, as discussed above, we proposed that the public could nominate additional cod es for review after this initial review period that

### CMS-1600-FC 692

had been on the CLFS for at least 5 years and had not b een reviewed in the previous 5 years. We sought comment on these proposals as well as alternative a pproaches to achieving our goal of paying appropriately for laboratory tests by accounting for ch anges in technology. Upon further reflection and based on these comments, we are modifying our approach to the identification and prioritization of codes

for review. We agree with the commenters who suggest that our proposal limits the ability to review a test code until it has been on the CLFS for at least 5 years. While we believe that addressing test codes that have been on the CLFS at least 5 years provides ample time for the technology to mature and diffuse, we recognize that there are circumstances that would wa rrant examining test codes for the payment revision process prior to this time. For example, new technol ogies could be developed that make it more or less costly to perform a test within a timeframe that is less than 5 years. Consistent with commenters’ suggestions, we also believe that we should expand the criteria for iden tifying and prioritizing test codes for review to include criteria, such as rapid spendi ng growth, high dollar payment, and high volume, as well as the oldest test codes on the CLFS, among other c onsiderations, rather than focusing on the oldest codes currently on the CLFS and codes that have been on the CLFS for at least 5 years. We believe that test codes that are most ripe for review will be test codes where the current payment amounts do not account for changes in technology that have occurre d since the test code was added to the CLFS and where the adjustments to the pa yment amounts will have a significant impact on payments made under the CLFS. We believe that expanding and maintaining flexibility with resp ect to the criteria will assist us in identifying and prioritizing test codes which are mo st ripe for revision. We will determine which test codes are most ripe for review based on an analys is of the data for test codes on the CLFS. Therefore, upon further reflection and based on these comments, we are finalizing a modified approach to identify and prioritize codes that will be reviewed every year. Each year, we will conduct a data analysis of codes on the CLFS to determine which codes should be proposed during the rulemaking cycle for a payment adjustment due to technological ch anges. This review will involve examining test codes in several different ways, such as examining those that have been on the CLFS the longest, those

### CMS-1600-FC 693

that are high volume test codes, those that have a high dollar payment, or those that have experienced rapid spending growth, among other considerations. As proposed, if we identify codes that are clinically and/or technologically similar to the ones identified through our data analysis process, we will consider

them for review at the same time as we review the related codes. As discussed previously, we also will allow the public to nominate codes for review.

Comment : Some commenters, along with MedPAC, asked that CMS not lower all payments and suggested that CMS must take into consideration the technological changes that may have added costs over the years. Response : We will not be automatically lowering all payment amounts on the CLFS. Rather, test codes and corresponding payment amounts will be re viewed on a case-by-case basis to determine how changes in technology have affected the cost of the test. As we stat ed in the CY 2014 PFS proposed rule (78 FR 43351) and above in this final rule with co mment period, we believe adjustments could be made to increase fee schedule amounts for certain tests (fo r example, in situations where new high cost technologies are employed), and to provide for reductions in existing amounts for other tests (for example in situations where technology reduces costs through increased efficiencies). A key goal in establishing this review process is to increase payment accuracy after technological changes; thus, payment amounts

could increase or decrease as a result of these reviews.

Comment : Some commenters recommended that CMS proceed through negotiated rulemaking,

so that interested stakeholders will have a say in the process. Response : Similar to what we stated above regard ing a formal advisory committee, we believe that using a negotiated rulemaking vehicle would be a time-consuming and resource intensive process. We believe that we can accomplish the same purpo se by utilizing the rulemaking process, under which we would propose payment revisions for identifie d test codes and provide a comment period during which the public could comment prior to the publication of the final rule (which would finalize any payment changes). During the comment period, th e public can nominate codes for review, provide information on how the technology for providing clin ical diagnostic laboratory tests has changed over

### CMS-1600-FC 694

time and suggest data to support revised payment amounts for particular test codes. Therefore, our annual rulemaking process will provide the public with ample opportunity to comment and interact with us as the process proceeds. CMS will retain the final authorit y in determining which test codes move forward through the payment revision process.

Comment : Several commenters suggested that the amount of a payment adjustment should be capped during the first year, and any remaining paymen t adjustment should be phased in over a number of years so that smaller laboratories or laboratories that offer only a small menu of tests would be minimally disrupted. Response : While we recognize that laboratories of different sizes or specialties may respond differently to market forces, our goal is to adjust payment amounts for test codes up for consideration in a given year as soon as possible to more accurately re flect the costs of these t ests based on changes in technology. Laboratories that may be affected by the examination of a payment amount for any specific test code will have the opportunity to comment through the rulemaking process.

Comment : Many commenters suggested that CMS recognize the difference between large and small laboratories so that small laboratories will not be phased out or forced out of business. Response : It is not our intention to eliminate or phase out any organization or business. Our goal is to adjust the payment amounts for tests on the CLFS to more accurately reflect the costs of tests based on technological changes, which should result in payment amounts under the CLFS being more commensurate with the current costs of providing these tests.

Comment : Several commenters recommended that CMS send proposed adjustments out to interested parties prior to any final decisions for feedback. Response : We agree that we need to provide noti ce and an opportunity to comment on proposed adjustments to the fee schedules due to technological ch anges to interested parties prior to finalizing these adjustments and we believe that our proposed process, which we are finalizing, does this. Specifically, the rulemaking process would propose payment revisions for the identified test codes and provide a comment period during which the public could comment pr ior to the publication of the final rule (which

### CMS-1600-FC 695

would finalize any payment adjustments). Therefor e, as proposed, we will utilize the rulemaking process with a comment period so that the public can provide information on how the technology of providing clinical diagnostic laboratory tests has changed over time and suggestions for data to support revised payment amounts on particular test codes.

Comment : Some commenters suggested creating a pilot program, a demonstration project, or competitive bidding for changing the payment amounts for codes on the CLFS. Response : We believe, similar to our response above concerning either a negotiated rulemaking process or an advisory board, that developing anythi ng formal such as a pilot program, a demonstration project, or competitive bidding would be a time-cons uming and resource intensive process. We believe that we can accomplish the same purpose by utiliz ing the rulemaking process with a comment period where the public can nominate test codes for review, provide information on how the technology for delivering clinical diagnostic laboratory services ha s changed over time and suggest data to support revised payment amounts on particular test codes. After considering all of the comments receive d, we are finalizing our proposal without modification to define technological changes as ch anges to the tools, machines, supplies, labor, instruments, skills, techniques, and devices by whic h laboratory tests are produced and used. We are finalizing our proposed process, including the prioriti zation of codes for review, with modification as

discussed above and noted below. Each year, we will conduct a data analysis of codes on the CLFS to determine which codes should be proposed during the rulemaking cycle for a payment adjustment due to technological changes. This review will involve examining test codes in sev eral different ways, such as examining those that have been on the CLFS the longest, those that are hi gh volume test codes, those that have a high dollar payment, or those that have experienced rapid spending growth, among other considerations. If we identify codes that are clinically and/or technologica lly similar to the ones identified through our data analysis process, we will consider them for review at th e same time as we review the related codes.

### CMS-1600-FC 696

For those codes where we determine that payment adjustments should be made, beginning with the CY 2015 PFS proposed rule (which will be pr omulgated during 2014 and any finalized payment adjustments would affect payments beginning CY 20 15), we will identify the test code, discuss how the test has been impacted by technological changes, and propose an associated adjustment to the payment amount for the test code as appropriate to reflect th e impact of such technological changes. We will solicit comment on the technology used to perform any tests we reviewed for possible payment changes, and any relevant cost information. 

### Under our process, the public may nominate test codes that are on the CLFS for review during the public comment period to the proposed rule. Test codes nominated for review by the public must include an explanati on from the nominator of the tec hnological change in the service and the way that change affects its delivery as we ll as any relevant cost information. CMS will retain the final authority in determining whic h test codes move forward through the payment revision process. For those c odes identified by the public for review where we determine that payment adjustments based on technological cha nges should be made, in the following year’s proposed rule, we will identify the test code, di scuss how it has been im pacted by technological changes, and propose an associated adjustment to the payment amount for the test code as appropriate to reflect the impact of such technological changes. We also will list any test codes that the public suggested for re view but for which we are not proposing to move forward through the payment revision process and explain why we are not proposing any changes at that time. Finalized payment revisions would take effect the following January 1. For example, test codes suggested during the comment period to the CY 2015 PFS proposed rule and agreed to by CMS for the payment revision process will be addr essed through the CY 2016 PFS rulemaking process with finalized payment adjustments being eff ective January 1, 2016. The CPI-U and multi-factor productivity adjustments will be applied after we establish the new payment amount through our

### CMS-1600-FC 697

usual instruction process. Finally, we are codifying our proposed defin ition of technological changes and the process at §414.511 with one technical correction. In §414.511(a), we are adding the words “fee schedules,” which we inadvertently omitted in the proposed rule. 3. Changes in the CY 2014 OPPS/ASC Final Rule with Comment Period In the CY 2014 PFS proposed rule (78 FR 43352), we notified readers that we were proposing to package payment for certain clinical diagnostic laboratory tests into the Ambulatory Payment Classification (APC) group payment for the signi ficant procedures and services with which those laboratory tests are billed in the CY 2014 OPPS/ASC pr oposed rule. We discussed this proposal in the section on “Proposed Changes to Packaged Item s and Services” in the CY 2014 OPPS/ASC proposed rule. For details on the final policy, please see the “Changes to Packaged Items and Services” section of the CY 2014 OPPS/ASC final rule with comment period.

### CMS-1600-FC 698

F. Liability for Overpayments to or on Behalf of Individuals including Payments to Providers or Other

Persons 1. Background and Statutory Authority CMS waives recovery of overpayments in certain situations for claims based fee-for-service provider, supplier or beneficiary overpayments in accordance with section 1870 of the Act. Section 1870(b) and (c) of the Act provide a waiver of recovery of provider, supplier or beneficiary overpayments under certain presumptions within a specified timefra me. Section 1870(b) and (c) of the Act allow the Secretary to reduce the specified time period to not le ss than 1 year if the Secretary finds that such a reduction is consistent with the objectives of the Medicare program. Section 638 of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112 –240, enacted January 2, 2013) changed the timeframes associated with section 1870(b) and (c) of the Act. Section 1870(b) of the Act provides for the waiver of recovery of an overpayment to a provider of services (hereinafter, “provider”) or other person when ever that provider or other person is “without fault” in incurring the overpayment. For purposes of section 1870 of the Act and this final rule with comment period, the term “other person” includ es practitioners, physicians , and other suppliers. Section 1870(b) of the Act also establishes circ umstances under which a provider or other person is presumed for administrative purposes to be “without fault” for an overpayment. If an overpayment is determined after a specified period of time, a provider or other person is presumed to be “without fault.” This presumption is negated, however, if there is ev idence to show that the provider or other person was responsible for causing the overpayment. Section 1870(c) of the Act provides for the waiver of recovery of an overpayment to an individual

whenever the individual is “without fault” in in curring the overpayment, and recovery would either defeat the purpose of the Social Security or Medicare programs or would be “against equity and good

conscience.” Section 1870(c) of the Act also establishes circumstances under which recovery of an overpayment for an individual is presumed to be “ag ainst equity and good conscience.” After a specified

### CMS-1600-FC 699

period of time, recovery of certain overpayments fro m individuals who are “without fault” is presumed “against equity and good conscience.” The overpayme nts addressed by this provision are payments for items or services for which payment may not be made because of the prohibitions found in section 1862(a)(1) or (a)(9) of the Act. Sections 1862(a)(1 ) and (a)(9) prohibit payment for, among other things, items and services that are not reasonable and necessary or that are for custodial care.

Section 638 of the ATRA amended the timeframe specified in section 1870(b) of the Act “without fault” presumption from 3 to 5 years so that the presumption of “without fault” only applies if the Medicare claims based fee-for-service overpayment determination for a provi der or other person is made subsequent to the fifth year (instead of the third year) following the year in which the notice was

sent to such individual that such amount had been paid. Likewise, section 638 of the ATRA amended the timeframe in section 1870(c) of the Act so that the presumption for “against equity and good conscience” for certain types of denials for an individual who is “without fault” only applies if the overpayment

determination is made subse quent to the fifth year (instead of the third year) following the year in which notice of such payment was sent to such individual. These ATRA changes do not affect or change CMS’ claims reopening regulation at §405.980. Specifically, we retain our authority to reopen claims for any reason within 1 year, for good cause within 4 years, and at any time for fraud or similar fault. 2. Provisions of the Proposed Regulations We proposed to revise §405.350(c) and §405.355(b). These revisions would change the timing of the triggering event for the “without fault” and “against equity and good conscience” presumptions.

These revisions reflect the revisions to section 1870 of the Act as specified in section 638 of ATRA. Specifically, we proposed to change the timeframe at §405.350(c) so that the rebuttable “without fault” presumption for the provider or other person would apply if the Medicare claims based fee-forservice overpayment determination is made subsequent to the fifth year (instead of the third year) following the year in which the notice was sent to su ch individual that such amount had been paid.

### CMS-1600-FC 700

Likewise, we proposed to amend the timeframe at §405.355(b) for the presumption “against equity and good conscience” for certain types of denial s for an individual who is “without fault” so that the presumption would apply if the overpayment determ ination is made subsequent to the fifth year (instead of the third year) following the year in whic h the notice of payment was sent to the individual. Additionally, in our review of the current regul ation implementing section 1870(c) of the Act, we noted that §405.355(b) does not clearly reflect the st atutory language, which limits the “against equity and good conscience” presumption to overpayments associated with denials under section 1862(a)(1) or (a)(9) of the Act. Accordingly, we proposed to update and clarify §405.355(b) so that it clearly reflects the statutory language by adding that the “against e quity and good conscience” presumption would be applicable for an individual who is “without fault” onl y if the overpayment is related to items and services that are not payable under section 1862(a)(1) or (a)(9) of the Act. In addition, we proposed to delete the parenthetical at the end of §405.355(b) because the re gulations referenced no lo nger exist; those sections of the regulations were reassigned. (See the October 11, 1989 Federal Register (54 FR 41733).) The modifications we proposed to §405. 355(b) make the references in th e parenthetical no longer necessary. The following is a summary of the comments we received regarding our proposals.

Comment : Commenters were opposed to CMS changi ng the timeframe for the “without fault” presumptions in §405.350(c) and §40 5.355(b) from 3 years to 5 years. These commenters expressed concern that changing the timeframe would require physi cians to be subject to audits, recovery initiatives, and other undue burdens, including onerous record -keeping requirements, for an additional 2 years despite inadvertently or unknowingly receiving the overpayments. Response : We are finalizing the revisions to the regulations as proposed and changing the timeframe for the “without fault” presumptions from 3 years to 5 years as specified in section 638 of ATRA. Although the Secretary has the authority to reduce the 5-year timeframe to not less than 1 year consistent with the objectives of the program, we do not believe that the Secretary has any basis for such reduction at this time, particularly in light of the Congressional intent expressed by the ATRA provisions.

### CMS-1600-FC 701

In addition, although section 638 of ATRA ch anged the timeframe for the “without fault” presumptions, ATRA did not change CMS’ claims re opening timeframes. (In accordance with §405.980, claims may be reopened within 1 year for any reas on, up to 4 years for good cause, and at any time for fraud or similar fault.) We believe maintaining the existing claim reopening timeframes will alleviate the

commenters concerns about an increased burden. We did not receive any comments on our propo sals to edit §405.355(b). Specifically, we proposed to (1) update and clarify §405.355(b) so that it clearly reflects the statutory language and (2) delete the parenthetical at the end of §405.355(b) b ecause the regulations referenc ed no longer exists. We are finalizing the updates to §405.355(b) as proposed.

### CMS-1600-FC 702

G. Physician Compare Website 1. Background and Statutory Authority Section 10331(a)(1) of the Affordable Care Act, requires that, by no later than January 1, 2011, we develop a Physician Compare Internet website with information on physicians enrolled in the Medicare program under section 1866(j) of the Act, as well as information on other eligible professionals who participate in the Physician Quality Reporting System (PQRS) under section 1848 of the Act. CMS launched the first phase of Physician Compare on December 30, 2010 (www.medicare.gov/physiciancompare ). In the initial phase, we posted the names of eligible professionals that satisfactorily submitted quality data for the 2009 PQRS, as required by section 1848(m)(5)(G) of the Act. Section 10331(a)(2) of the Affordable Care Act al so requires that, no later than January 1, 2013, and for reporting periods that begin no earlier than January 1, 2012, we implement a plan for making publicly available through Physician Compare in formation on physician performance that provides comparable information on quality and patient experience measures. We met this requirement in advance of January 1, 2013, as outlined below, and intend to continue to address elements of the plan through rulemaking.

To the extent that scientifica lly sound measures are developed and are available, we are required to include, to the extent practicable, the fo llowing types of measures for public reporting:

● Measures collected under the PQRS.

● An assessment of patient health outc omes and functional status of patients.

● An assessment of the continuity and coordi nation of care and care transitions, including episodes of care and risk-adjusted resource use.

● An assessment of efficiency.

● An assessment of patient experience and patient, caregiver, and family engagement.

● An assessment of the safety, effectiveness, and timeliness of care.

● Other information as determined appropriate by the Secretary.

### CMS-1600-FC 703

As required under section 10331(b) of the Affordable Ca re Act, in developing and implementing the plan, we must include, to the extent practicable, the following:

● Processes to ensure that data made public are statistically valid, reliable, and accurate, including risk adjustment mechan isms used by the Secretary.

● Processes for physicians and eligible prof essionals whose information is being publicly reported to have a reasonable opportunity, as determined by the Secretary, to review their results before posting to Physician Compare. This would consis t of a 30-day preview period for all measurement performance data that will allow phys icians and other eligible professi onals to view their data as it will appear on the website in advance of publication. Details of the preview process will be communicated on the Physician Compare Initiative page on CMS. gov in advance of the preview period.

● Processes to ensure the data published on Ph ysician Compare provides a robust and accurate portrayal of a physician’s performance.

● Data that reflects the care provided to all pa tients seen by physicians, under both the Medicare program and, to the extent applicable, other payers, to the extent such information would provide a more accurate portrayal of physician performance.

● Processes to ensure appropriate attribution of care when multiple physicians and other providers are involved in the care of the patient.

● Processes to ensure timely statistical perform ance feedback is provided to physicians concerning the data published on Physician Compare.

● Implementation of computer and data infrastru cture and systems used to support valid, reliable and accurate reporting activities. Section 10331(d) of the Affordable Care Act requi res us to consider input from multi-stakeholder groups in selecting quality measures for Physician Compare, which we are working to accomplish through a variety of means including rulemaking and various forms of stakeholder outreach. In developing the plan for making information on physician performance publicly available through Physician Compare, section 10331(e) of the Affordable Care Act requires the Secretary, as the Secretary

### CMS-1600-FC 704

deems appropriate, to consider the plan to trans ition to value-based purchasing for physicians and other practitioners that was developed under section 131(d) of the Medi care Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275, enacted on July 15, 2008). Under section 10331(f) of the Affordable Care Ac t, we are required to submit a report to the Congress, by January 1, 2015, on Physician Compare development, and include information on the efforts and plans to collect and publish data on physician qua lity and efficiency and on patient experience of care in support of value-based purchasing and consumer choice. Initial work on this report is currently underway. Section 10331(g) of the Affordable Care Ac t provides that any time before that date, we may continue to expand the information ma de available on Physician Compare.

We believe section 10331 of the Affordable Ca re Act supports our overa rching goals of providing consumers with quality of care information to make informed decisions about their healthcare, while encouraging clinicians to improve on the quality of care they provide to their patients. In accordance with section 10331 of the Affordable Care Act, we inte nd to utilize Physician Compare to publicly report physician performance results. 2. Public Reporting of Physician Performance Data Since the initial launch of the website, we have continued to build on and improve Physician Compare. In 2013, we launched a full redesign of Physician Compare offering significant improvements including a complete overhaul of the underlying data base and a new Intelligent Search feature, addressing two of our stakeholders’ primary critiques of the site and considerably improving functionality and usability. The primary source of administrative information on Physician Compare is the Provider Enrollment, Chain, and Ownership System (PECOS); as the sole source of verified Medicare professional information, PECOS remains the primary information source. However, with the redesign, we incorporated the use of Medicare claims information to verify the information in PECOS to ensure only

the most current and accurate information is included on the site. The following is a summary of general comments we received about the website and its redesign.

### CMS-1600-FC 705

Comment : We received positive comments regarding our use of Medicare claims to verify information in PECOS; however, some commenters did express concerns with lingering data issues regarding basic demographic information, specialty classification, and hospital affiliation. Some commenters urged CMS to address these concerns prior to posting quality measure performance information on the site. Other commenters request ed we implement a streamlined process by which professionals can correct their information in a timely manner. Response : We appreciate the commenters’ feedback regarding concerns over the accuracy of the information currently available on Physician Compar e. CMS is committed to including accurate and upto-date information on Physician Compare and con tinues to work to make improvements to the information presented. The underlying database on Physician Compare is generated from the PECOS as well as Fee-ForService (FFS) claims and it is therefore critical that physicians, other health care professionals, and group practices ensure that their information is up-to-dat e and as complete as possible in the national PECOS database. Currently, the most immediate way to a ddress inaccurate PECOS data on Physician Compare is by updating information via Internet-based PECOS at https://pecos.cms.hhs.gov/pecos/login.do . Please note that the specialties as reported on Physician Compare are those specialties reported to Medicare when a physician or other healthcare professional enro lls in Medicare and are limited to the specialties noted on the 855i Enrollment Form. And, all addr esses listed on Physician Compare must be entered in and verified in PECOS. To upda te information not found in PECOS , such as hospital affiliation and foreign language, professionals and group practices sh ould contact the Physician Compare team directly

at 

### physiciancompare@westat.com . Understanding the value of a mo re real-time option for updating information on Physician Compare and the ability to update all information in one place, we are evaluating the feasibility of such a mechan ism for potential future development. The following is a summary of the comments we received rega rding the new Intelligent Search functionality:

### CMS-1600-FC 706

Comment : We received comments concerning primar y care specialties being listed with other specialties in the search results. One commenter noted that when they conducted a search for “neurosurgery” they were directed to select names of physicians from family practice, neurology and then neurosurgery - in that order. One commenter who searched for “general surg eons” was surprised that thirteen primary care physicians were listed as relate d to general surgery. Another commenter requested that CMS remove the “Search all Family Practice, General Practice, Geriatric Medicine, Internal Medicine, and Primary Healthcare Professionals” opti on as a result from searches for a specific type of specialist. They also requested that for searches where primary care may be applicable but not most appropriate, the all primary care option should be listed last. Response : The purpose of Physician Compare is to connect users with a comprehensive list of physicians and other healthcare professionals that are capable of assisting them with their health-related concerns. Since primary care is generally the prin cipal point of consultation for patients within the Medicare system, a link to search for all primary care sp ecialties is always offered to patients as an option in the drop down list and/or results list. Based on feedback from both stakeholders and consumers received since the functionality went live, we are r eevaluating how this information is presented on the site so it does not appear, for instance, that when you search for “neurosurgery” you are seeing primary care physicians because they are related to neurosurgery.

Comment : Some commenters felt that the search resu lts were too broad a nd not actionable for patients. Commenters requested that CMS work with stakeholders such as state and national specialty societies to improve the accuracy of Physician Comp are in associating specialists with different body parts and diseases. Response : We appreciate the commenters' feedback on the Intelligent Search functionality. The development of this search function is an ongoing process and it will conti nue to evolve through quarterly updates. CMS values the input of stakeholders concerning the Intelligent Search. The Physician Compare team worked closely with specialty societies in the development of the initial Intelligent Search

### CMS-1600-FC 707

function and continues to seek input and conduct ou treach to ensure that the terms and phrases powering the search function are as comprehensive and accurate as possible.

Comment : One commenter noted that the search function for group practices does not work, citing that if one enters a zip code that is close to the group practice's primary address, the group practice does not appear. Response : Search results are displayed on the webs ite based on proximity to the center of the location searched, therefore search results may vary depe nding on if a zip code or a city/state search is conducted. In addition, the search results are genera ted using an auto-expand feature. The distance will vary depending on the location and type of search. All searches start at one mile and if less than 10 individuals or groups are found within that distan ce, the search radius will automatically expand incrementally until it reaches a sufficient amount of resu lts. If sufficient results are returned, however, the search will not expand. This may lead to a group pr actice nearby not being displayed because there are a sufficient number of practices closer to the cente r of the search radius to satisfy the search. Currently, users can view information about approved Medicare professionals such as name, primary and secondary specialties, practice locations, group affiliations, hospital a ffiliations that link to the hospital’s profile on Hospital Compare as ava ilable, Medicare Assignment status, education, languages spoken, and American Board of Medical Sp ecialties (ABMS) board certification information. In addition, for group practices, users can also view group practice names, specialties, practice locations, Medicare Assignment status, and affiliated professionals.

Comment : We received two comments regarding the publication of the ABMS board certification information. One commenter suggest ed that we add additio nal information on board certification such as contextual information regard ing the certification process, as well as identifying the certifying Board and not just the specialty. Anot her commenter urged CMS to include other board’s certifications, in addition to ABMS. Response : We appreciate the commenters' feedback . We will evaluate the feasibility of including a link to the ABMS website so that users can get additional information about certification, as

### CMS-1600-FC 708

well as certifying board information. And, we will ev aluate the feasibility of potentially including data on Physician Compare from other board certification sources in a future website release, if the information is available and it is technically feasible. As required by 1848(m)(5)(G) of the Act, we are required to post on a CMS website the names of eligible professionals who satisfa ctorily report under the PQRS, as well as those eligible professionals who are successful electronic prescribers under th e Medicare Electronic Prescribing (eRx) Incentive Program. Physician Compare contains a link to the list of those names. In addition to the list of names, there is a section on each individual’s profile pa ge listing the quality programs under which the specific individual satisfactorily reported or if the individual was a successful electronic prescriber. The program name is listed and a green check mark clearly indi cates which programs the individual satisfactorily or successfully participated in. These data will be update d annually with the most recent data available. With the Physician Compare redesign, we have also added a quality programs section to each group practice profile page in order to indicate whic h group practices are satisfactorily reporting in Group Practice Reporting Option (GPRO) under the PQRS or are successful electronic prescribers under the eRx Incentive program. We have also included a notati on and check mark for individuals that successfully participate in the Medicare EHR Incentive Program, as authorized by section 1848(o)(3)(D) of the Act. These data will be updated with the most recent data available.

Comment : One commenter urged CMS to reconsider its decision to publicly report on meaningful use data due to the ongoing issues related to the EHR program--including unresolved challenges related to interoperability of certified systems, concerns about the relevancy of meaningful use objectives to certain providers, and the large investme nt associated with EHR a doption that continues to make it cost prohibitive for small practices despite incentives. Response : We appreciate the commenter’s feedback on including EHR participation information. However, as this proposal was previously finali zed, these data are currently available on Physician Compare. We believe the benefits of including th ese data, the growth of the program, and consumer interest in EHR adoption warrant the incl usion of these data on Physician Compare.

### CMS-1600-FC 709

As we finalized in the 2013 PFS final rule w ith comment period (77 FR 69166), we will include the names of those eligible professionals who repor t the PQRS Cardiovascular Prevention measures group in support of the Million Hearts Initiative by including a check mark in the quality programs section of the profile page. Finally, we will also indicate in this manner those individuals who have earned the PQRS Maintenance of Certification Incentive starti ng with data reported for CY 2013. We will update this information annually moving forward.

Comment : One commenter requested that Ameri can Board of Optometry (ABO) certified optometrists who earn the PQRS MOC bonus be r ecognized on the Physician Compare website. Response : We appreciate the commenter's feedback on including an indication on Physician Compare for participation in the additional PQ RS Maintenance of Certification incentive for Optometrists. As all successful participants in the additional PQRS Maintenance of Certification incentive will have an indication of their participa tion on Physician Compare, this information will be included on the site when the information is published. We are now instituting our plan for a phased a pproach to public reporting of performance information on Physician Compare. The first phase of our plan was finalized with the 2012 PFS final rule with comment period (77 FR 69166), where we establi shed that PQRS GPRO m easures collected through the GPRO web interface during 2012 wo uld be publicly reported on Physician Compare. These measures will be publicly reported on Physician Compare in ear ly CY 2014. We expanded our plan with the 2013 PFS final rule with comment period (77 FR 69166) where we established that the specific GPRO web interface measures that would be posted on Physic ian Compare include the Diabetes Mellitus (DM) and Coronary Artery Disease (CAD) PQRS GPRO measures, and that we would develop and report composite measures for these measure groups in future years, if technically feasible. Data reported in

2013 under the GPRO DM and GPRO CAD measure s and composites collected via the GPRO web interface that meet the minimum sample size of 20 patie nts, and that prove to be statistically valid and reliable, will be publicly reported on Physician Compare in late CY 2014, if technically feasible. As we previously established, if the minimum threshold is no t met for a particular measure, or the measure is

### CMS-1600-FC 710

otherwise deemed not to be suitable for public re porting, the group’s perform ance rate on that measure will not be publicly reported.

Comment : Several commenters requested CMS ensure the data reported on Physician Compare be accurate and reliable, citing that inaccurate data can damage physicians' reputations, result in false assumptions about care, and potentially lead to ha rmful consequences for patients. Commenters also strongly urged CMS to risk adjust the measures. So me commenters noted that there is an overreliance on process measures that are not linked to outcomes a nd that provide minimal value to consumers in comparing providers, or for assuring that ph ysicians are providing high quality care. Response : We appreciate the commenters’ feedback, and understand their concerns. As required under section 10331(b) of the Affordable Care Act, in developing and implementing the plan to include performance data on Physician Compare, we must incl ude, to the extent practicable, processes to ensure that the posted data are statistically valid, reliable, and accurate, including risk adjustment mechanisms used by the Secretary, as well as processes to ensure appropriate at tribution of care when multiple providers are involved in the care of the patient. We understand that this informa tion is complex, and are committed to providing data on Physician Compare that are useful to beneficiaries in assisting them in making informed healthcare decisions, while being accurate, valid, reliable, and complete. We will closely evaluate all quality measures under considera tion for public reporting on the website to ensure they are presented in a way that is helpful to benefi ciaries and, through consumer testing and stakeholder outreach, work to present this inform ation in an accurate and user-friendly way. We also appreciate the

commenters’ feedback and understand the interest in focusing more on patient-centered outcome measures versus process measures. CMS will take this f eedback into consideration for future rulemaking. In the Medicare Shared Savings Program fina l rule (76 FR 67948), we noted that because Accountable Care Organization (ACO) providers/suppliers that are elig ible professionals are considered to be a group practice for purposes of qualifying fo r a PQRS incentive under the Shared Savings Program, we would publicly report ACO performance on quality measures on Physician Compare in the same way

### CMS-1600-FC 711

as we report performance on quality measures for PQRS GPRO group practices. Public reporting of performance on these measures will be presented at the ACO level only. As part of our public reporting plan, in the CY 2013 PFS final rule with comment period (77 FR 69167), we also finalized our decision to publicly re port Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) data for group practices of 100 or more eligible professionals reporting data in 2013 under the GPRO, a nd for ACOs participating in the Shared Savings Program. We anticipate posting these data on Physician Compare as early as 2014. 3. Future Development of Physician Compare We will continue to phase in an expansion of Ph ysician Compare over the next several years by incorporating quality measures from a variety of sources, as technically feasible. We previously finalized a decision to publicly report on Physician Compare the performance rates on a limited set of web interface quality measures that group practices submit under the 2012 and 2013 PQRS GPRO web interface (76 FR 73417 and 77 FR 69166). For 2014, we proposed to expand the quality m easures posted on Physician Compare by publicly reporting in CY 2015 performance on all measures collect ed through the GPRO web interface for groups of all sizes participating in 2014 under the PQRS GPRO and for ACOs participating in the Medicare Shared Savings Program (78 FR 43354). These data would include measure performance rates for measures reported that met the minimum sample size of 20 patients, and that prove to be statistically valid and reliable. We noted we will provide a 30-day pr eview period prior to publication of quality data on Physician Compare so that group practices and ACOs can view their data as it will appear on Physician Compare before it is publicly reported, and that we will detail the process for the 30-day preview and provide a detailed timeline and instructions for previe w in advance of the start of the preview period.

Comment : We received both positive and negative co mments regarding our proposal to expand public reporting to all performance measures collected through the GPRO web interface. Commenters in support of the expansion highlight that it will be easi er to identify a core set of measures on which to gauge a group practice’s overall rate of performance. Another commenter noted that the expansion will

### CMS-1600-FC 712

allow Physician Compare to report a wider selection of useful, actionable information to assist consumers in making informed choices about where they receive their care. Commenters opposed to the expansion felt that Physician Compare should revert to its origin al proposal to initially only report on a limited set of web interface measures noting that the public repor ting of performance data should occur gradually and carefully to ensure the data are accurate and presente d in a format that is easy to understand, meaningful,

and actionable for consumers. Another commenter noted that the public reporting of physician performance data is a new undertaking for both CMS and the public and could have serious implications if it is not executed appropriately. Response : We appreciate the commenters' feedback . We proposed an expanded set of web interface measures in 2014 as these measures provide an opportunity for more group practices to be able to have relevant data publically reported on Physician Compare and because this will provide consumers with more information to help them make inform ed healthcare decisions. Regarding concerns about gradually and carefully including additional quality of care information, 2014 will be the third year of data publicly reported on Physician Compare. The previous 2 years of public reporting will provide experience using a limited set of measures, allowing CMS to ensure an appropriate process and accurate data. Moving to a greater number of measures in 2014 is part of a gradual and phased approach. Also, CMS has been working to ensure the data are presented in a way that is both accurate and most useful to consumers through consumer testi ng and stakeholder outreach, starting with the 2012 data. Therefore, sufficient work in this area is being conducted to en sure the data are properly reported. We are thus finalizing this proposal to expand the quality measures posted on Physician Compare by publicly reporting in CY 2015 performance on all measures collect ed through the GPRO web interface for groups of all sizes participating in 2014 under the PQRS GP RO. For ACOs participating in the Medicare Shared Savings Program, performance on the ACO GPRO m easures will be reported pu blicly on Physician Compare in the same manner as group practices that report under the PQRS GPRO (76 FR 67948).

Comment : We received several comments in support of the 30-day preview period prior to publication of quality data . Many commenters urged CMS to a llow physicians, group practices, and

### CMS-1600-FC 713

ACOs the opportunity to correct and/or appeal any er rors found in the performance information before it is posted on the site. Other commenters felt that a 30-day preview period was insufficient and requested that CMS extend the period up to 45, 60, or 90 days. One commenter recommends that CMS allow a preview period prior to any inform ation being added to the website. Response : We appreciate the commenters’ feedback in support of the 30-day preview period for quality measures on Physician Compare. This 30-day pe riod is in line with the preview period provided for other public reporting programs such as Hospital Compare. We will provide a 30-day preview period for confidential measure preview. If measure data ha ve been collected and the measure has been deemed suitable for pubic reporting, the data will be published on Physician Compar e. As such, there will not be a formal appeals process. However, if an error is f ound in the measure display during the preview period, there will be options to contact the Physician Compar e team by both phone and e-mail. Errors will be corrected prior to publication. We also appreciate the commenters’ feedback re garding extending the 30-day preview period for quality measures on Physician Compare. However, due to our commitment to make this information available to the public in as time ly a manner as possible and the website development timeline, a longer preview period is not possible at this time. Groups an d individuals that will have measure data posted will be informed in advance of the preview period a nd the logistics necessary to access the confidential preview, review their data, and contact the Physicia n Compare team if needed. We believe this 30-day period provides ample time to accomplish these goals as evidenced by other programs, such as Hospital Compare. At this time it is not feasible to incorporate a 30-day preview period for non-measure data, such as address, phone number, specialty, etc., included on the Physician Compare website as this would produce an unacceptable lag and limit our ability to provide up-to-date information to consumers that can assist them in making informed healthcare decisions. We also received comments regarding the patient sample size of 20 patients. A patient sample size of 20 patients was previously finalized (77 FR 69166) for publication of the Diabetes and CAD

### CMS-1600-FC 714

measures. As we are now expanding the PQRS GPRO measures available for public reporting on Physician Compare, this sample size would also apply to this expande d set of measures.

Comment : Two commenters expressed their concerns regarding the minimum patient sample size, citing that using such a small sample size will result in inaccurate and misleading information regarding the actual activities of the physician practic e. One commenter recommended that we raise the sample size to 30. Another noted it was important to include sample size information on Physician Compare to help users better unders tand the measures being reported. Response : We appreciate the commenters’ feedback regarding the patient sample size and including this information on Physician Compare. We are committed to reporting quality of care data that is statistically valid, relia ble, and accurate, and will on ly post data that meet th is standard of reliability regardless of threshold, and regardless of measure type. Should we find a measure meeting the minimum threshold to be invalid or unreliable for any reason, the measure will not be reported. We believe this threshold of 20 patients is suffici ent. It is a large enough sample to protect patient privacy for reporting on the site, and it is the reliability threshold previously finalized for both the ValueBased Modifier (VBM) and the PQRS criteria for re porting measure groups (77 FR 69166). As we work to align quality initiatives and minimize reporti ng burden on physicians and other healthcare professionals, we are finalizing a patient sample size of 20 patients for the expanded set of PQRS GPRO measures available for public reporting on Physician Compare. For 2013, we expanded PQRS GPRO to include a registry reporting option (77 FR 69166). For 2014, we are expanding the PQRS GPRO further to include an option to report data via EHR. Consistent with the requirement under section 10331(a)(2)(A) of the Affordable Care Act to make publicly available information on quality measures submitted by physici ans and other eligible professionals under PQRS, we proposed to publicly report on Physician Comp are performance on certain measures that groups report via registries and EHRs in 2014 for the PQRS GPRO ( 78 FR 43354). Specifically, we proposed to report, no earlier than 2015, performance on the GPRO registry and EHR measures identified below that can also be reported via the GPRO web interface in 2014. By proposing to include on Physician Compare

### CMS-1600-FC 715

performance on these measures reported by participants under the GPRO through registries and EHRs, as well as the GPRO web interface, we stated we would c ontinue to provide beneficiaries with a consistent set of measures over time. For registry reporting, publicly reported measures would include:

● Diabetes: Hemoglobin A1c Poor Control.

● Heart Failure (HF): Beta-Blocker Therapy fo r Left Ventricular Systolic Dysfunction (LVSD).

● Medication Reconciliation.

● Preventive Care and Screening: Influenza Immunization.

● Pneumococcal Vaccination Status for Older Adults.

● Preventive Care and Screening: Breast Cancer Screening.

● Colorectal Cancer Screening.

● Coronary Artery Disease (CAD): Angiotensin-converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy -- Diabetes or Left Ventricular Systolic Dysfunction (LVEF < 40%).

● Adult Weight Screening and Follow-Up.

● Preventive Care and Screening: Screening for Clinical Depression.

● Coronary Artery Disease (CAD): Lipid Control.

● Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic.

● Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention.

● Hypertension (HTN): C ontrolling High Blood Pressure.

● Ischemic Vascular Disease (IVD): Complete Lipid Panel and LDL Control.

● Preventive Care and Screening: Screen ing for High Blood Pressure and Follow-Up

Documented. For EHR reporting, publicly re ported measures would include:

● Diabetes: Hemoglobin A1c Poor Control.

● Heart Failure (HF): Beta-Blocker Therapy fo r Left Ventricular Systolic Dysfunction (LVSD).

● Preventive Care and Screening: Influenza Immunization.

### CMS-1600-FC 716

● Pneumococcal Vaccination Status for Older Adults.

● Preventive Care and Screening: Breast Cancer Screening.

● Colorectal Cancer Screening.

● Adult Weight Screening and Follow-Up.

● Coronary Artery Disease (CAD): Lipid Control.

● Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic.

● Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention.

● Hypertension (HTN): C ontrolling High Blood Pressure.

● Ischemic Vascular Disease (IVD): Complete Lipid Panel and LDL Control.

● Preventive Care and Screening: Screen ing for High Blood Pressure and Follow-Up

Documented.

Comment : Commenters were opposed to the expansi on of public reporting to include measures reported through the registry and EHR reporting opt ions. Some commenters expressed concern that measures reported through different reporting mech anisms may not be comparable. One commenter

believes CMS should first validate that the measure specifications are interpreted consistently across groups and across reporting mechanisms. One commenter suggests that it is too soon to have reporting entities publicly post performance data from electroni c clinical quality measures (eCQMs) citing that additional work should be done to verify the valid ity and accuracy of the measure results. Another commenter recommends that CMS include a notation specifying the selected reporting mechanism with a simplified descriptor and accompanying measure set. Such a notation would ensure that patients are

made aware of the differences in measure sets across the different reporting mechanisms and it will allow them to know which providers reported on the same measures when comparing performance. Response : We appreciate the commenters' feedback regarding including measures collected via both registries and EHRs. Though we understand co ncerns regarding includin g measures collected via different mechanisms, analyses are being conducted to ensure that these measures are consistently

understood and the consistencies and inconsistencies across repor ting mechanism are understood and

### CMS-1600-FC 717

appropriately addressed for the purposes of publicly reporting these measures. Analyses are also being conducted to ensure that the eCQMs produce valid and accurate results. Only those measures finalized to be published on Physician Compare that are proven to be comparable and most suitable for public reporting will be included on Physician Compare. Because we believe the appropriate steps are being taken to ensure that the proposed measures collected via registries and EHRs are comparable to the web interface measures, such as detailed analyses of the measure specifications across reporting mechanisms, and also valid and reliable, and for the various reas ons we discussed previously, we are finalizing the proposal to publish in CY 2015 the measures identifie d above that are collected via registries and EHRs during 2014, if technically feasible. CMS will also indicate the mechanism by which these data were collected, as we understand the concerns raised regarding potential differences in me asures collected via different reporting mechanism. Analyses are ongoing to be sure these differences are fully understood. Consistent with the requirement under section 10331(a)(2) of the A ffordable Care Act to make comparable information on patient experience of car e measures publicly available, we previously finalized a plan to post performance on patient expe rience survey-based measures from the Clinician and Group Consumer Assessment of Healthcare Provi ders and Systems (CG-CAHPS) (77 FR 44804) including the following patient experience of care me asures for group practices participating in the PQRS GPRO (77 FR 44964):

● CAHPS: Getting Timely Care, Appointments, and Information.

● CAHPS: How Well Your Doctors Communicate.

● CAHPS: Patients’ Rating of Doctor.

● CAHPS: Access to Specialists.

● CAHPS: Health Promotion and Education These measures capture patients’ experiences with clinicians and their staff, and patients’ perception of care. We finalized a decision to publicly report performance on these measures on Physician Compare in CY 2014 for data collected for 2013 for group practices with 100 or more eligible

### CMS-1600-FC 718

professionals participating in the PQRS GPRO in 2013 and reporting data through the GPRO web interface (77 FR 69166). At least for data reported for 2013, we noted that we would administer and collect patient experience survey data on a samp le of the group practices’ beneficiaries. Consistent with the PQRS policy of publicly re porting patient experience measures on Physician Compare starting with data collected for 2013, for ACOs participating in the Shared Savings Program, we will publicly report patient experien ce data in addition to the measur e data reported through the GPRO web interface. Specifically, the patient experience me asures that would be reported for ACOs include the CG-CAHPS measures in the Patient/Caregiver Expe rience domain finalized in the Shared Savings Program final rule (76 FR 67889):

● CAHPS: Getting Timely Care, Appointments, and Information.

● CAHPS: How Well Your Doctors Communicate.

● CAHPS: Patients’ Rating of Doctor.

● CAHPS: Access to Specialists.

● CAHPS: Health Promotion and Education.

● CAHPS: Shared Decision Making

● CAHPS: Health Status/Functional Status For data reported for 2014, we proposed to c ontinue public reporting CG-CAHPS data for PQRS GPRO group practices of 100 or more eligible prof essionals participating in the GPRO via the web interface and for Shared Savings Program ACOs re porting through the GPRO web interface or other CMS-approved tool or interface (78 FR 43355). Cons istent with what we finalized for 2013 under the PQRS GPRO, we stated we would administer and fu nd the collection of data for these groups. Because we will be administering and collecting the data fo r these surveys, we did not anticipate public reporting to impose any notable burden on these groups. We believe these patient surveys are important tools for assessing beneficiary experience of care and outcomes, and under our authority under section 1848(m)(3)(C) of the Act to select the measures for which a group practice must report under the PQRS, we stated that we sought to encourage groups of 25

### CMS-1600-FC 719

or more eligible professionals to report CG-CAHPS by proposing to make these measures available for reporting under the PQRS and for the Value Based Paym ent Modifier. We proposed to publicly report 2014 CG-CAHPS data for any group practice (regardless of size) that voluntarily chooses to report CGCAHPS; however, we stated that CMS would not fund the surveys for these groups of 2 to 99 eligible professionals. We proposed to publicly report compar able CG-CAHPS data collected by groups of any size collected via a certified CAHPS vendor in CY 2015 (78 FR 43355). We are dedicated to publicly reporting accurate, valid, and relia ble data on Physician Compare and are aware that each group practice is unique in size and scope. We have closely evaluated the available data collection mechanisms, and are conf ident that CG-CAHPS is a well-tested collection mechanism with strong support from the healthcare community, and that it provides the best opportunity to collect useful and accurate data for the largest number of group practices. We proposed to use only those survey domains that are applicable to group practices or ACOs respectively, and believed that these domains have been well tested, and would therefore provide the best data for the largest number of

groups. We received several comments related to our proposals to publicly report CG-CAHPS measures on Physician Compare. The following is a summary of the comments we received:

Comment : Several commenters support our proposal to continue posting data for groups of 100 or more eligible professionals. Commenters were al so generally supportive of the proposal to publish patient experience data for smaller groups; however, some commenters requested clarification on the size of group practice that CMS intends to publicly report, noting that there is conflicting language within the proposed rule regarding groups of 25 or more vers us groups “regardless of size.” Several of the commenters expressed their disappointment that CMS w ill not fund the data collection for these smaller groups, noting that it is extremely costly and burde nsome on smaller practices to implement CAHPS. Response : We appreciate the commenters' feedback regarding our proposals to continue publicly reporting CG-CAHPS measures for groups of 100 or mo re eligible professionals with CY 2014 data and

### CMS-1600-FC 720

to begin publicly reporting CG-CAHPS measures for gr oups of 25 to 99 that voluntarily submit these data to meet PQRS reporting requirements. We are dedicated to accurate, valid, and reliabl e public reporting on Physician Compare and are aware that each group practice is unique and that opi nions vary across patients. However, as noted, we

are confident that CG-CAHPS is a well-tested coll ection mechanism that produces valid and comparable measures of physician quality. Per the requirement under section 10331(a)(2) of th e Affordable Care Act to make comparable information on patient experience of care measures public ly available, as noted above, and due to the fact that these data are greatly valued by consumer s and will assist consumers with making informed healthcare decisions, we are finalizing the proposal to continue to publicly report CG-CAHPS measures for groups of 100 or more eligible professionals who participate in PQRS GPRO, regardless of GPRO submission method, and for Shared Savings Program ACOs reporting through the GPRO web interface or other CMS-approved tool or interface. As in 2013, CMS will support this survey data collection for group practices who participate in PQRS GPRO via the web interface. As patient experience data are required under section 10331(a)(2) of the Affordable Care Act, we are working to ensure that a greater set of measures are available for public reporting to help more group practices find measures that are relevant to them and to ease burden of reporting as some grou ps may already be collecting CG-CAHPS data under additional domains. For these reasons, we are finaliz ing that, if technically feasible, for these PQRS GPROs of 100 or more eligible professionals, we will collect data for additional summary survey measures. Specifically, we will collect data for the 12 summary survey measures also being finalized for groups of 25 to 99 for PQRS reporting requirements, namely:

● Getting timely care, appointments, and information;

● How well providers Communicate;

● Patient’s Rating of Provider;

● Access to Specialists;

● Health Promotion & Education;

### CMS-1600-FC 721

● Shared Decision Making;

● Health Status/Functional Status;

● Courteous and Helpful Office Staff;

● Care Coordination;

● Between Visit Communication;

● Helping Your to Take Medication as Directed; and

● Stewardship of Patient Resources. For the same reasons noted above, for groups of 25 to 99 eligible professionals, we are finalizing the proposal to publicly report on Physician Compare the CG-CAHPS measures collected on the 12 summary survey measures noted ab ove when collected via a certified CAHPS vendor, as technically

feasible. We will evaluate the data collected and will only publish those measures deemed suitable for public reporting and that prove to be comparable. As with all measure da ta reported on Physician Compare, there will be a 30-day preview period where groups can preview their data prior to its publication on the site. We appreciate the commenter's feedback and the fact that collecting CG-CAHPS data is an expense for smaller group practices. However, if sm aller group practices are already collecting these data for internal use, we want to be sure that they are able to have the opportunity to have them published on the site. Therefore, we are finalizing this proposal. CMS will not fund collection of these data for groups

of 25 to 99.

Comment : Several commenters opposed the publi cation of CAHPS measures citing that the measures are not relevant to their particular specia lty. They request that CMS allow physicians the flexibility to select the survey instruments and patie nt satisfaction measures most appropriate for their practices. Many of the commenters recommended CM S use Surgical CAHPS as an optional patient experience of care measure. Response : We appreciate the commenters' feedback re garding the request for CMS to be flexible in the CAHPS surveys publicly reported to ensure the measures are as relevant as possible to all

### CMS-1600-FC 722

specialties. We understand that CG-CAHPS is not the most applicable CAHPS su rvey for all specialties and service settings represented by groups on Physic ian Compare. Therefore, we will evaluate the feasibility of including additional CAHPS surveys, such as S-CAHPS, on the site in the future. However, at this time CG-CAHPS provides the best opportunity to reach the largest number of groups with a single survey instrument. CG-CAHPS measures are also be ing incorporated into the PQRS program, which means that there will more likely be a sufficient number of groups reporting on these measures to allow comparable reporting. For these reasons and because we are working to phase in measures over time, we

will not be able to accommodate additional CAH PS measures on Physician Compare at this time. In the CY 2013 PFS final rule with comment peri od (77 FR 44804), we indicated our intention to publicly report performance rates on quality measur es included in the 2014 PQRS and for individual eligible professionals consistent with the requirements under section 10331 of the Affordable Care Act to provide information about physicia ns and other eligible professionals who participate in PQRS. We believe that individual-level measure data is impor tant in helping consumers make informed healthcare

decisions and that this information should be posted on the site as soon as technically feasible. Therefore, in the proposed rule, we proposed to publicly repor t comparable data, as noted below, collected for the 2014 PQRS via claims, EHR or registry from indivi dual eligible professionals as early as CY 2015 (78 FR 43355). Specifically, we proposed to post indi vidual measures reported by individual eligible professionals in line with those measures reported by groups through the GPRO web interface. We proposed to include the following measures:

● Diabetes: Hemoglobin A1c Poor Control.

● Heart Failure (HF): Beta-Blocker Therapy fo r Left Ventricular Systolic Dysfunction (LVSD).

● Medication Reconciliation.

● Preventive Care and Screening: Influenza Immunization.

● Pneumococcal Vaccination Status for Older Adults.

● Preventive Care and Screening: Breast Cancer Screening.

● Colorectal Cancer Screening.

### CMS-1600-FC 723

● Coronary Artery Disease (CAD): Angiotensin-converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy -- Diabetes or Left Ventricular Systolic Dysfunction (LVEF < 40%).

● Adult Weight Screening and Follow-Up.

● Preventive Care and Screening: Screening for Clinical Depression.

● Coronary Artery Disease (CAD): Lipid Control.

● Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic.

● Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention.

● Hypertension (HTN): C ontrolling High Blood Pressure.

● Ischemic Vascular Disease (IVD): Complete Lipid Panel and LDL Control.

● Preventive Care and Screening: Screen ing for High Blood Pressure and Follow-Up

Documented.

● Falls: Screening for Fall Risk.

● Diabetes Mellitus: Low Density Lipoprotein (LDL-C) Control.

● Diabetes Mellitus: High Blood Pressure Control.

● Diabetes Mellitus: Hemoglobin A1c Control (<8%).

Comment : Some commenters supported the CMS provision to provide quality information on the individual physician level as soon as feasible. Th e majority of commenters, however, were opposed to the proposal to report 2014 PQRS individual measure data in CY 2015. Some commenters are concerned that it may not be feasible to accurately represent a physician’s performance, because at the individual physician/eligible professional leve l, there is not always an adequate sample size to make valid comparisons. Other commenters believe that since mu ltiple physicians can be involved in the treatment of a patient, it can be difficult to assess who ultimately is responsible for the care of that patient when evaluating a specific measure. One commenter is co ncerned that by reporting individual quality measures providers would have an incentive to turn away patie nts with low health literacy, inadequate financial resources to afford treatment, and ethnic groups tradit ionally subject to healthcare inequities in order to

### CMS-1600-FC 724

improve their process measure performance. Other commenters encourage CMS to limit the publication of measure data to group practices until there is sufficient experience and data to determine what measures, if any, can be reported at the individual level. . Response : We appreciate the commenters’ feedback but believe strongly that individual-level measure data are important in helping consumers ma ke informed healthcare decisions, and that this information should be posted on the site as soon as te chnically feasible. However, we appreciate the concerns raised by other commenters' regarding posting individual measures. We are committed to including only the most accurate, statistically reliable and valid quality of care m easure data on Physician Compare when the data are publicly reported. Any da ta found to be invalid or inaccurate for any reason will not be publicly reported. And, we are confiden t that the sample size noted will produce comparable data as these measures have been in use in the PQRS program and have undergone significant review. We

understand that attribution of care is a concern at the i ndividual physician level, but believe that it can be appropriately determined for the purposes of these measur es. We do not believe that collecting data at the individual physician level will cause physicians to turn away patients just as data collection at the hospital and group practice level have not. And, to further he lp mitigate this concern, we will evaluate risk adjustment to ensure that those physicians that serve a more complex patient population are not unduly penalized. In future years, we will continue to evalua te the available measures and work to ensure that the data on Physician Compare are those best suited for public reporting. We will ensure that these data are collected and presented appropriately, regardless of th e mechanism through which they are collected, and that they accurately reflect performance. Only t hose measures that are reported for the accepted sample size will be publicly reported. And, CMS will work to ensure that the measures are presented in a way that is understood by consumers. We will also evaluate the inclusion of language to help users understand why not all individuals will have quality data re ported. Given the importance of making individual eligible professional-level measure data available to the public, CMS is finalizing this proposal to publicly report 2014 PQRS individua l measure data in CY 2015 for individual PQRS quality measures listed, if technically feasible.

### CMS-1600-FC 725

Additionally, and in support of the HHS-wide M illion Hearts Initiative, we proposed to publicly report, no earlier than CY 2015, performance rates on measures in the PQRS Cardiovascular Prevention measures group (see Table 116 at 77 FR 69280) at th e individual eligible professional level for data collected in 2014 for the PQRS (see Table 74 of this rule).

Comment : We received three comments regarding the publication of the PQRS Cardiovascular Prevention measures group. Two commenters request th at CMS clearly and prominently state that certain physicians or groups are not included in the M illion Hearts initiative for numerous reasons. One commenter encouraged CMS to limit public reporting of these measures to the group practice level, citing

concerns that these measures if collected via EHRs ar e new for physicians to re port, and thus CMS should allow at least two more years of data collection on these measures before publicly reporting them. Response : We appreciate the commenters’ feedback. We appreciate the concern that reporting via an EHR is new for many physicians and it may ta ke time to become comfortable with the reporting mechanism. However, these measures are not new to PQ RS and thus have been previously reported. As noted above concerning individual PQRS measures, we recognize the importance of making individual eligible professional-level measure data available to the public, and find these measures to be specifically relevant to the Physician Compare audience, and are, th erefore, finalizing this proposal to publicly report

in CY 2015 the individual Cardiovascular Prevention measures in support of the Million Hearts Initiative, if technically feasible. We are evaluating the feasi bility of including clarification language to explain why it may not be appropriate for physicians or groups to report these Cardiovascular Prevention measures and will include this language if feasible. Please note that, during the comment period follow ing the proposed rule, we received comments that were not related to our specific proposals for Physician Compare in the CY 2014 PFS proposed rule. While we appreciate the commenters’ feedback a nd intend to use these comments to better develop Physician Compare, these comments will not be speci fically addressed in this CY 2014 PFS final rule with comment period, as they are beyond the scope of this rule. However, we will take these comments into consideration when developing policies a nd program requirements for future years.

### CMS-1600-FC 726

H. Physician Payment, Efficiency, and Quality Improvements – Physician Quality Reporting System This section contains the final requirements for the Physician Quality Reporting System (PQRS). The PQRS, as set forth in sections 1848(a), (k), and (m) of the Act, is a quality reporting program that provides incentive payments and payment adjustments to eligible professionals and group practices based on whether or not they satisfactorily report data on quality measures for covered professional services furnished during a specified reporting period. The regulation governing the PQRS is located at §414.90. The program requirements for the 2007 through 2014 PQRS incentives and the 2015 PQRS payment adjustment that were previously established, as we ll as information on the PQRS, including related laws and established requirements, are available at http://www.cms.gov/Medicare/Quality-Initiatives-PatientAssessment-Instruments/PQRS/index.html . In addition, the 2011 PQRS and eRx Experience Report, which provides information about e ligible professional participation in PQRS, is available for download

at http://www.cms.gov/Medicare/Quality-Initiatives-Patie nt-Assessment-Instruments/PQRS/index.html

. We note that eligible professionals in critical acces s hospitals (CAHs) were previously not able to participate in the PQRS. Due to a change we are maki ng in the manner in which eligible professionals in CAHs are reimbursed by Medicare, it is now feasible for eligible professionals in CAHs to participate in the PQRS.

In the CY 2013 PFS final rule with comment period (77 FR 69170), we finalized certain requirements for the 2013 and 2014 PQRS incentives, as well as 2015 and 2016 PQRS payment adjustments. We also finalized certain requirements for future years, such as the reporting periods for the PQRS payment adjustment, as well as requirements for the various PQRS reporting mechanisms. In the CY 2014 PFS proposed rule, we proposed to change some requirements for the 2014 PQRS incentive and 2016 PQRS payment adjustment, as well as to make cha nges to the PQRS measure set. Furthermore, we introduced our proposals for a new PQRS reporting op tion – satisfactory partic ipation in a qualified clinical data registry. This final rule with comment period addresses these proposals and specifically outlines the final requirements for the 2014 PQRS incentive and 2016 PQRS payment adjustment.

### CMS-1600-FC 727

Please note that, during the comment period follow ing the proposed rule, we received comments that were not related to our specific proposals for PQRS in the CY 2014 PFS proposed rule. In addition, we also solicited comment on a general plan for futu re years for PQRS, so that we may continue to consider stakeholder feedback as we develop policies and proposals for the future. While we appreciate

the commenters’ feedback and intend to use th ese comments to better develop PQRS, these comments will not be specifically addressed in this CY 2014 PFS final rule with comment period, as they are beyond the scope of this rule. However, we will take these comments into consideration when developing policies and program requirements for future years. 1. Changes to §414.90 As noted previously, the regulation governing the PQRS is located at §414.90. We proposed the following changes and technical corrections to §414.90 (78 FR 43357):

● Under §414.90(b), we proposed to modify the definition of administrative claims to eliminate the words “the proposed” in the phrase “on the proposed PQRS quality measures.” We proposed to make this technical change because this language was inadve rtently included in the final regulation despite the fact that the quality measures that eligible professiona ls report under the PQRS were finalized in the CY

2013 PFS final rule with co mment period (77 FR 69364).

● We proposed to modify §414.90(f) to include the phrase “for satisfactory reporting” after the title “Use of consensus-based quality measures.” We proposed to add the phrase “for satisfactory reporting” so that it is clear that the paragraph refe rs to satisfactory reporting, not the new standard of satisfactorily participating in a qualified clinical data registry.

● We proposed to modify the paragraph heading of §414.90(g) to add the phrase “satisfactory reporting”, so that the title of the paragraph reads “Satisfactory reporting requirements for the incentive payments.” We proposed to make this change so that it is clear that the paragraph refers to satisfactory reporting, not the new standard of satisfactorily partic ipating in a qualified clinical data registry. Please note that, due to additional changes we are making to §414.90, paragraph §414.90(g) is now designated as §414.90(h).

### CMS-1600-FC 728

● We proposed to modify the paragraph head ing of §414.90(h) to add the phrase “satisfactory reporting”, so that the title of the paragraph reads “Satisfactory reporting requirements for the incentive payments.” We proposed to make this change so that it is clear that the paragraph refers to satisfactory reporting, not the new standard of satisfactorily partic ipating in a qualified clinical data registry. Please note that, due to additional changes we are making to §414.90, paragraph §414.90(g) is now designated as §414.90(j).

● We proposed to delete paragraph §414.90( i)(4), because §414.90(i)(4) list requirements that are identical to §414.90(i)(3), and therefore, redundant. In addition, we considered further revising th e regulation at §414.90 to list all the specific satisfactory reporting requirements for the 2014 PQRS incentive and 2016 PQRS payment adjustment, so that the different reporting requirements are specified in the regulation. We are making this change. Therefore, we are adding newly redesignated paragra phs §414.90(h)(3), §414.90(h)(5), §414.90(j)(3), and §414.90(j)(5) to list all the specific satisfactory re porting requirements for the 2014 PQRS incentive and 2016 PQRS payment adjustment. We solicited but received no public comment on th ese proposals. Therefore, we are finalizing these proposed technical changes. In the course of revising the regulation text to address the technical changes and final policies we are adopting in this final rule, we discovered a number of drafting errors and technical issues. In addition to the technical changes and corrections noted above, as well as the substantiv e changes discussed in the sections that follow, we also are modifying §414.90 as follows:

● Changing references to the Physician Quality Reporting System to its acronym, the PQRS, throughout §414.90 to sh orten the regulation. This technical cha nge is consistent with the references to the program we have made in the proposed rule.

● Deleting the phrase “as defined in paragraph (b) of this section” when referring to group practices throughout §414.90, because it is redundant to refer back to the definition of a group practice.

### CMS-1600-FC 729

● Amending §414.90(d) to indicate that, in lieu of satisfactory reporting, an eligible professional may also satisfactorily participate in a qua lified clinical data registry in 2014.

● Changing the title of §414.90(f) currently titled “Use of consensus-based quality measures” to “Use of appropriate and consensus-based quality measur es for satisfactory reporting” to indicate criteria

for measure selection for measures available unde r the group practice reporting option (GPRO).

● Combining §414.90(f)(1) and §414.90(f)(2) as measures under the PQRS may fit either of

these two criteria.

● Adding paragraph (n) entitled “Limitations on review.” This “limitations on review” paragraph, previously designated in §414.90 as para graph (k) was inadvertently deleted from §414.90 in the CY 2013 PFS final rule with comment period. In lieu of this section, a duplicate paragraph (k) describing the PQRS informal review process was in serted. We are therefore deleting the duplicate informal review paragraph (k) and restoring paragraph (n). In addition, the previously established paragr aph entitled “limitations on review” included the following paragraph at §414.90(k)(2): “The determination of the payment limitation.” This provision pertains to the Electronic Prescribing (eRx) Incentive Pr ogram and is irrelevant to the PQRS. Therefore, we are deleting that reference. Moreover, to be consistent section 1848(m)(5)(E) of the Act, we are adding to the “limitations on review ” paragraph the following: “The determination of satisfactory reporting.”, which was inadvertently left out (presu mably because we inadvertently listed an element of the eRx Incentive Program instead, as noted above). Th is technical change also necessary so that newly designated paragraph (l) will be consistent with section 1848(m)(5)(E) of the Act. Although we did not include these technical cha nges in the proposed rule, we believe it is unnecessary to undergo notice and comment rulemaking gi ven that these changes are purely technical in nature and correct errors inadvertently made previous ly to the regulation, and do not substantively change the regulation. Finally, we note that we have ma de further structural and conforming changes to the regulation (for example, adding, deleting, and redesign ating paragraphs) consiste nt with the changes and final policies we are adopting in this final rule.

### CMS-1600-FC 730

2. Participation as a Group Practice in the Group Practice Reporting Option (GPRO) – Changes to the Self-nomination, or Registration, Requirement for Gr oup Practices to be Selected to Participate in the

GPRO In the CY 2013 PFS final rule with comment pe riod (77 FR 69172), we finalized requirements regarding the self-nomination process group practices must follow to participate in the PQRS GPRO. In the CY 2014 PFS final rule with comment period, we proposed (78 FR 43357) to make the changes to those requirements for group practices to self-nominate. First, we proposed to change the deadline of October 15 of the year in whic h the reporting period occurs for group practices to submit a selfnomination statement, or register, to participate in the PQRS GPRO. Starting with reporting periods occurring in 2014, we proposed (78 FR 43357) to change this deadline to September 30 of the year in which the reporting period occurs (tha t is, September 30, 2014, for reporting periods occurring in 2014). We solicited and received the following public co mments regarding our proposal to change the deadline that a group practice must regi ster to participate in the GPRO:

Comment : Several commenters did not support our proposal to change the deadline that a group practice must register to participate in the GPRO by September 30 of the year in which the reporting period occurs (that is September 30, 2014 for reporti ng periods occurring in 2014) suggesting that it is important that group practices are allowed more time to decide on whether they should participate in PQRS as a group practice or as individuals. The comme nters felt that the later registration deadline of October 15 of the year in which the reporting period occurs or later allows more time for group practices to make a more informed decision, as well as acc ount for changes in the composition of the group practice, such as changes in a group practi ce’s Taxpayer Identification Number (TIN). Response : While we understand the commenters’ concer ns and proposed a deadline of September 30 of the year in which the reporting period occurs, we noted in the proposed rule (78 FR 43357) that CMS needs additional time to identify group practices wish ing to participate in the GPRO for a year in order to allow for more time to populate the GPRO we b interface for those group practices that select the GPRO web interface reporting mechanism. Unfort unately,we cannot finalize a deadline later than

### CMS-1600-FC 731

September 30. Despite the comments we received requesting a later deadline, based on the reasons previously mentioned, we are requiring that group practices register to participate in the GPRO by September 30 of the year in which the reporting peri od occurs (that is September 30, 2014 for reporting periods occurring in 2014), as proposed.

We note that we received comments related to proposals for the Value-based Payment Modifier (discussed in section III.K. of this final rule with comment period) requesting more timely feedback on group practice reporting, particularly information related Clinician Group C onsumer Assessment of Healthcare Providers and Systems (CG CAHPS) survey. Since the performance of a group practice in the Value-based Payment Modifier is determined, in part , by a group practice’s participation in the PQRS, to provide timelier feedback to these group practices, in or der for eligible professionals to be able to receive feedback on CG CAHPS data and assess by the Value- based Payment Modifier, it would be necessary for CMS to identify which groups will be participati ng in the PQRS under the GPRO earlier than September 30 of the year in which the reporting period occurs. Therefore, to respond to the commenters concerns to provide timelier feedback on performance on CG CAHPS in the future, we anticipate proposing an earlier deadline for group practices to register to pa rticipate in the GPRO in future years.

Second, we proposed (78 FR 43357) that group practices comprised of 25 or more individual eligible professionals that wish to report the CG CAHPS survey measures (which are discussed later in this section) would be required via the web to el ect to report the CG CAHPS survey measures. We solicited and received no comments on this proposal. Ther efore, we are finalizing our proposal to require group practices of 25 or more individual eligible prof essionals that wish to report the CG CAHPS survey measures to indicate their intent to do so upon registration. Furthermore, we proposed (78 FR 43357) that the website that a group practice would use to elect to report the CG CAHPS survey measures would be th e same website used by group practices to register to participate in the PQRS GPRO. We believe that providing a single website whereby group practices may make multiple elections (such as submitting the self-nom ination statement to register to participate in

### CMS-1600-FC 732

the PQRS GPRO and be evaluated for the PQRS GP RO using CG CAHPS measures would be desirable for group practices.

We solicited and received the followi ng public comments on this proposal:

Comment : Several commenters supported our proposal to use a single website to register to participate in the PQRS GPRO. The commenters be lieved that using a single website for functions relating to different CMS programs furthers CMS’ goal of alignment, as well as aids in the group practice’s management in participation in CMS’ va rious quality reporting programs. Commenters urged CMS to further align and create a single website th at will manage participation in the PQRS, EHR Incentive Program, and the Value-based Payment Modifier. Response : We appreciate the commenters’ feedback a nd the support for this proposal. For the reasons stated above, we are finalizing our proposal to use a single website whereby a group practice of 25 or more individual eligible professionals may register to participate in the PQRS GPRO and elect to be evaluated for the PQRS GPRO by reporting CG CAHPS measures. 3. Requirements for the PQRS Reporting Mechanisms The PQRS includes the following reporting mechanisms : claims; registry; EHR (including direct EHR products and EHR data submi ssion vendor products); administrative claims; and the GPRO webinterface. Under the existing PQRS regulation, section 414.90(g) and (h) govern which reporting

mechanisms are available for use by individuals and group practices for the PQRS incentive and payment adjustment. This section contains the changes we are finalizing for these PQRS reporting mechanisms. In addition, this section contains the final require ments for two new PQRS reporting mechanisms – a new certified survey vendor reporting mechanism for purposes of reporting CG CAHPS measures and a qualified clinical data registry reporting mechan ism under the new PQRS “satisfactory participation” reporting option. a. Registry-based Reporting Mechanism In the CY 2013 PFS final rule with comment peri od, we finalized the following requirement for registries to become qualified to participate in PQRS for 2013 and beyond: Be able to collect all needed

### CMS-1600-FC 733

data elements and transmit to CMS the data at the TIN/NPI level for at least 3 measures (77 FR 69180). In the proposed rule, since we proposed (78 FR 43358) to increase the number of measures eligible professionals would be required to report for the 2 014 PQRS incentive from 3 to 9 measures covering at least 3 of the National Quality Strategy (NQS) dom ains, we proposed (78 FR 43358) to change this registry requirement as follows: A qualified registry mu st be able to collect all needed data elements and transmit to CMS the data at the TIN/NPI level for at least 9 measures covering at least 3 of the NQS domains. We solicited but received no public comment on this proposal. Therefore, as we describe in detail below, since we are finalizing our proposal to increase the number of measures eligible professionals would be required to report for the 2014 PQRS incentive vi a qualified registry from 3 to 9 measures covering at least 3 of the NQS domains, we are finalizing this proposal. b. Certified Survey Vendors We proposed (78 FR 43358) to allow group pr actices composed of 25 or more eligible professionals to report CG CAHPS survey measures. The data collected on these CAHPS survey measures would not be transmitted to CMS via the pr eviously established PQRS group practice reporting mechanisms (registry, EHR, or GPRO web interface) . Rather, the data must be transmitted through a survey vendor. Therefore, to allo w for the survey vendor to transmit survey measures data to CMS, we proposed to modify §414.90(b), §414.90(g)(3), and §414.90(h)(3) to propose a new reporting mechanism – the certified survey vendor (78 FR 43358). We so licited and received the following public comment on this proposal:

Comment : Several commenters supported our proposal to allow group practices of 25-99 eligible professionals to report the CG CAHPS survey measur es and therefore generally supported our proposal to create a new reporting mechanism – the CMS-certified survey vendor – to administer the CG CAHPS

survey measures. Response : We appreciate the commenters’ feedback and are finalizing the creation of a new reporting mechanism, the CMS-certified survey vendo r, to report the CG CAHPS survey measures. Therefore, we are finalizing our proposal to m odify §414.90(b), newly designated §414.90(h)(3), and

### CMS-1600-FC 734

newly designated §414.90(j)(3) to indicate a group prac tice’s ability to use a new reporting mechanism – the CMS-certified survey vendor.

Comment : Although commenters supported our propo sal to allow group practices of 25-99 eligible professionals to report the CG CAHPS surv ey measures, the commenters opposed our proposal to require these group practices to report the CG CAHP S survey measures via a CMS-certified survey vendor. The commenters believed that group practices should have the flexibility to report CG CAHPS measures in any way the group practices choose, not solely through a CMS-certified survey vendor. Response : While we appreciate the commenters’ con cern to allow flexibility in allowing group practices to report the CG CAHPS measures, we must create parameters surrounding how the CG CAHPS survey measures would be reported to CMS. Similar to our other reporting mechanisms, we believe it is also important to ensure that vendors are able to test submission of CG CAHPS measures data prior to the submission period. We believe that requiring that the vendor be certified by CMS to submit CG CAHPS survey measures data furthers this goal. Therefore, we are requiring that group practices use a CMS-certified survey vendor if the group practice wishes to report CG CAHPS survey measures data for purposes of the PQRS. In addition, §414.90(g)(3 ), and §414.90(h)(3) currently requi res group practices to use only one mechanism to meet the requirements for satisfact ory reporting (that is, CMS will not combine data submitted under multiple reporting mechan ism to determine if the requirements for satisfactory reporting are met). However, for the proposed certified surv ey vendor option, we also proposed that a group practice choosing to report CG CAHPS survey measu res would be required to select an additional reporting mechanism to meet the requirements for satisfactory reporting for both the 2014 PQRS incentive and the 2016 PQRS payment adjustment (78 FR 43358). Therefore, we proposed to modify §414.90(g)(3), and §414.90(h)(3) to indicate that groups selecting to use the certified survey vendor would be the exception to this requirement. We received no public comment on this proposal and therefore, for the reasons we previously stated, ar e finalizing our proposal to modify newly designated §414.90(h)(3), and §414.90(j)(3) to indicate that groups selecting to use the certified survey vendor would

### CMS-1600-FC 735

be required to meet the criteria for satisfactory reporting using an additiona l reporting mechanism to report additional measures. For purposes of PQRS, we proposed to modify §414. 90(b) to define a certified survey vendor as a vendor that is certified by CMS for a particular progr am year to transmit survey measures data to CMS (78 FR 43358). To obtain CMS certification, we proposed that vendors would be required to undergo training, meet CMS standards on how to administer the survey, and submit a quality assurance plan. CMS would provide the identified vendor with an ap propriate sample frame of beneficiaries from the group. The vendor would also be required to administ er the survey according to established protocols to ensure valid and reliable results. Survey vendors woul d be supplied with mail a nd telephone versions of the survey in electronic form, and text for beneficiar y pre-notification and cover letters. Surveys can be administered in English, Spanish, Cantonese, Manda rin, Korean, Russian and/or Vietnamese. Vendors would be required to use appropria te quality control, encryption, security and backup procedures to maintain survey response data. The data would then be securely sent back to CMS for scoring and/or

validation. To ensure that a vendor possesses the ability to transmit surv ey measures data for a particular program year, we proposed to require survey vendors to undergo this certification process for each year in which the vendor seeks to transmit survey measures da ta to CMS. We solicited and received no public comment on these proposals. Therefore, we are finaliz ing these proposals, as well as the proposed change at §414.90(b). 4. Changes to the Criteria for the Satisfactory Re porting for Individual Eligible Professionals for the 2014 PQRS Incentive – Individual Quality Measures Submitted via Claims and Registries and Measures Groups Submitted via Claims For 2014, in accordance with §414. 90(c)(3), eligible professionals that satisfactorily report data on PQRS quality measures are eligible to receive an in centive equal to 0.5 percent of the total estimated Medicare Part B allowed charges for all covered professional services furnished by the eligible professional or group practice during the applicable reporting period. Individua l eligible professionals may currently report PQRS quality measures data to m eet the criteria for satisfactory reporting for the

### CMS-1600-FC 736

2014 PQRS incentive via the claims, registry, an d EHR-based reporting mechanisms. This section contains our final changes to the criteria for sa tisfactory reporting of indi vidual quality measures via claims and registries by individual eligible professi onals for the 2014 PQRS incentive. Please note that we did not propose to modify and are therefore not modifying the criteria for satisfactory reporting of individual quality measures via EHR that were estab lished in the CY 2013 PFS final rule with comment period (see Table 91, 77 FR 69194). For ease of reference, these criteria for satisfactory reporting of individual quality measures via EHR for the 2014 PQRS incentive are also identified again in Table 47 of this final rule with comment period. a. Proposed Changes to the Criterion for Satisfact ory Reporting of Individual Quality Measures via Claims for Individual Eligible Professionals for the 2014 PQRS Incentive In the CY 2013 PFS final rule with comment peri od (see Table 91, 77 FR 69194), to maintain the reporting criterion with which indi vidual eligible professionals are fa miliar, we finalized the same satisfactory reporting criterion for the submission of individual quality measures via claims that we finalized in previous years: For the 12-month reporting period for the 2014 PQRS incentive, report at least 3 measures, OR, if less than 3 measures apply to the eligible professional, report 1—2 measures, AND report each measure for at least 50 percent of the eligible professional’s Medicare Part B FFS patients seen during the reporting period to which th e measure applies. Measures with a 0 percent performance rate would not be counted. For an elig ible professional who reports fewer than 3 measures via the claims-based reporting mechanism, the eligib le professional would be subject to the Measures Applicability Validation (MAV) process, which woul d allow us to determine whether an eligible professional should have reported quality data c odes for additional measures (77 FR 69188). Under our authority to revise the criteria for sa tisfactory reporting for the 2014 PQRS incentive under section 1848(m)(3)(d) of the Act, we proposed (78 FR 43358) to change the criterion for the satisfactory reporting of individual, claims-based measures by individual eligible professionals for the 2014 PQRS incentive as follows: For the 12-month reporting period for the 2014 PQRS incentive, report at least 9 measures, covering at least 3 of the NQS domains, OR, if less than 9 measures apply to the

### CMS-1600-FC 737

eligible professional, report 1—8 measures, AND report each measure for at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent performance rate would not be counte d. For an eligible professional who reports fewer than 9 measures covering less than 3 NQS domains via the claims-based reporting mechanism, the eligible professional would be subject to the MAV process, which would allow us to determine whether an eligible professional should have reported quality data codes for add itional measures. We proposed to allow eligible professionals to report fewer than 9 meas ures so that eligible professionals who do not have at least 9 claims-based PQRS measures applicable to his/her practice would still have an opportunity to still meet the criteria for satisfactory reporting for the 2014 PQRS incentive by reporting on as many applicable claims-based measures as th e eligible professionals can report. We solicited public comment on the proposed change to the criterion for the satisfactory reporting of individual quality measures via claims for indi vidual eligible professionals for the 2014 PQRS incentive and received the following comments:

Comment : Several commenters supported our proposal to increase the number of measures to be reported via claims, as requiring an eligible professi onal to report on more measures would better capture the quality of care provided by an eligible professional. Response : We appreciate the commenters’ feedback and, based on the supportive comments

received and for the reasons mentioned above and in the proposed rule (78 FR 43358), are finalizing this proposed criterion.

Comment : While several commenters generally supported our proposal to increase the number of measures and NQS domains to be reported via claims, the commenters urged CMS to take a more gradual approach to increasing the number of measures that must be reported via claims. These commenters suggested requiring the reporting of either 4 measu res covering at least 1 NQS domain, 5 measures covering at least 2 NQS domains, or 6 measures covering at least 2 NQS domains. Response : We appreciate the commenters’ support for our desire to increase the number of measures to be reported via claims, as well as their alternative suggestions on how to increase the number

### CMS-1600-FC 738

of measures to be reported via claims. As we e xplain in more detail when we discuss our final requirements for the 2016 PQRS payment adjustment, we agree that a more gradual increase in the number of measures to be reported may be necessary for purposes of meeting the criteria for satisfactory reporting for the PQRS payment adjustments. However, since the PQRS program has provided incentives for satisfactory reporting since 2007, we belie ve it is appropriate to increase the number of measures to be reported via claims from 3 measure s covering 1 NQS domain to 9 measures covering 3 NQS domains for the 2014 PQRS incentive. We belie ve 6 years is enough time for eligible professionals to familiarize themselves with the reporting op tions for satisfactory reporting under the PQRS. Additionally, we point out that we will be using a MAV process for i ndividual eligible professionals who report less than 9 measures via claims, given that an eligible professional who does not have at least 9 measures covering less than 3 NQS domains applicable to his/her practice may report the number of measures applicable to the eligible profession (i.e., fe wer than 9 measures) to attempt to meet the criteria for satisfactory reporting for the 2014 PQRS incentiv e via claims. Through the MAV process, we will determine whether the eligible professional reported the measures applicable to the eligible professional. For the commenters’ suggested alte rnative criteria, while we understa nd the commenters’ concerns, we believe our interest in aligning the satisfactory repor ting criteria of individual measures via claims with the satisfactory reporting criteria of individual measu res via EHR for the 2014 PQRS incentive outweighs the need for such a gradual increase in the number of measures required to be reported via claims.

Comment : One commenter stated that we should not align the PQRS reporting criteria for reporting mechanisms other than the EHR-based reporti ng mechanisms with the reporting criteria for the EHR Incentive Program, as the objectives for the two programs are different. Response : We respectfully disagree. Although the standards and criteria for which the PQRS and EHR Incentive Program provide incentives and relieve eligible professionals from payment adjustments are different, the two programs are both dedicated to the promotion of EHR technology and the collection of meaningful and quality data.

### CMS-1600-FC 739

Comment : The majority of commenters opposed our proposal to increase the number of measures to be reported via claims from 3 measures cove ring 1 NQS domain to 9 measures covering 3 NQS domains. Several of these commenters generally oppo sed any proposal that would increase the number of measures to be reported via claims from 3 measures covering 1 NQS domain. Some of these commenters noted that they have been successful at meeting th e criteria for satisfactory reporting in the PQRS via claims in the past, and increasing the number of meas ures to be reported via claims would make it more difficult for these eligible professionals to meet the criteria for satisfactory reporting for the 2014 PQRS incentive. Other commenters urged CMS not to increase the criteria for satisfactory reporting until participation in PQRS increases, as the commenters feared that increasing the criteria for satisfactory reporting in PQRS would discourage eligible professiona ls from participating in the PQRS. Still some of the commenters opposing this proposal noted that certa in eligible professionals did not have 9 measures covering 3 NQS domains for which to report. These commenters stressed that being able to report at least 9 measures covering 3 NQS domains via claims for the 2014 PQRS incentive would be particularly difficult since we are proposing to eliminate the cl aims-based reporting mechanism as an option to report certain PQRS measures. Some of these commenters also expressed concern that certain practices having a limited number of applicable measures will not ha ve applicable measures covering at least 3 NQS

domains. Response : We understand the commenters’ concerns. As we noted above and in the proposed rule (78 FR 43358), we believe th at we have provided eligible professionals with enough time to familiarize themselves with the reporting options for satisfactory reporting under the PQRS, particularly for the PQRS incentives. For the commenters who urge us not to increase the satisfactory reporting criteria for the PQRS until participation in PQRS increases, we understand that , as discussed in this final rule below and in the 2011 PQRS and eRx Reporting Experience, participati on in the PQRS has fluctuated around 25 percent among those eligible to participate in the PQRS. Indeed, it is one of our major goals to increase participation in the PQRS. While increasing the satisfactory reporting threshold for the 2014 PQRS

### CMS-1600-FC 740

incentive may deter or discourage eligible professionals from participating, we do not believe increased threshold we are finalizing will significantly deter e ligible professionals from participating in the PQRS primarily given that the 2016 PQRS payment adjustme nt is applicable, and the reporting periods of the 2016 PQRS payment adjustment run concurrently with the reporting periods for the 2014 PQRS incentive. Since eligible professionals are required to meet the criteria for satisfactory reporting for the 2016 PQRS payment adjustment to avoid a reduction to the physician fee schedule payments, we believe these eligible professionals will also attempt to repor t for the 2014 PQRS incentive regardless of whether

we increase the measure threshold from 3 measure s covering 1 NQS domain to 9 measures covering 3 NQS domains. For the commenters’ concerns on not having at least 9 PQRS measures covering 3 NQS domains for which to report via claims, particular ly since we proposed to eliminate the claims-based reporting mechanism as a mechanism for which to re port certain measures, we note that our proposal, which we are finalizing, allows eligible professionals to report 1-8 measures that are applicable, if the eligible professional does not have 9 applicable meas ures to report. If an eligible professional does not have 9 applicable measures to report, the eligible professional must report on as many measures covering as many domains as are applicable to his/her practice. For example, if an eligible professional only has 7 measures covering 2 NQS domains applicable to his/ her practice, he/she must report all 7 measures covering 2 NQS domains in order to meet the cr iteria for satisfactory reporting for the 2014 PQRS

incentive. It would not be suffici ent for the eligible professional to report on, for example, 6 measures covering 2 NQS domains or 6 measeures covering 1 NQS domain. Given this aspect of the satisfactory reporti ng criterion, which would address these commenters concerns, we believe it is appropr iate to finalize this satisfactor y reporting criterion and the general increase in measures to up to 9. Also, we note that for eligible professionals wh o report 1-8 measures, we will use the MAV process. The current claims MAV process for the 2013 PQRS incentive is only triggered when an eligible professional reports on 1 or 2 measures covering 1 NQS domain via claims since, to meet the criteria for satisfactory reporting for the 2013 PQRS incentive, an eligible professional is only required to report on 3 measures covering 1 NQS domain (77 FR 69189). Since we are increasing

### CMS-1600-FC 741

the satisfactory reporting threshold from 3 measures covering 1 NQS domain to 9 measures covering at least 3 NQS domains, we are amending the 2013 MAV process for claims so that the 2014 claims MAV process will be triggered when an eligible professiona l reports on less than 9 measures covering at least 3 NQS domains. Therefore, the MAV process will be tr iggered when an eligib le professional reports on either less than 9 measures or measures covering less than 3 NQS domains. If an eligible professional reports on less than 9 measures, the MAV process will also check to determine whether the eligible professional is reporting of the maximum amount of NQS domains (up to 3 NQS domains) applicable. For example, if an eligible professional reports on 8 measures covering 2 NQS domains, the MAV process will be triggered to determine whether an eligible professional could have reported on at least 9 measures and covering at least 3 NQS domains. Likewise, if an eligible professional reports on 9 measures covering 2 domains, the MAV process will be triggered to determine whether an eligible professional could have reported on me asures covering an additional domain. As in previous years, the MAV process will use a two-part test – (1) a “clinical relation” test, and (2) a “minimum threshold” test – to determine whether an eligible professiona l could have reported on more measures. To get a better sense of how the 2014 MAV process for claims will be implemented by CMS, please see our documentation explaining the current 2013 MAV process for claims. A description of the current claims MAV process is available at http://www.cms.gov/Medicare/Quality-Initiatives-PatientAssessmentInstruments/PQRS/Downloads/2013_PQRS_Measu reApplicabilityValidation_Docs_030413.zip . Please note that we will post a guidance document on the 2014 claims MAV process, which will include a list of

the measure clusters that are used for the “minimum th reshold” test, prior to January 1, 2014 (the start of the 2014 reporting periods). In summary, we are adding paragraph §414.90(h)(3) to specify that, to meet the criterion for satisfactory reporting of individual, claims-based me asures by individual eligible professionals for the 2014 PQRS incentive an eligible professional must, for the 12-month reporting period for the 2014 PQRS incentive, report at least 9 measures covering at least 3 NQS domains, OR, if less than 9 measures

### CMS-1600-FC 742

covering at least 3 NQS domains apply to the elig ible professional, report 1—8 measures covering 1-3 NQS domains as applicable, AND report each measure fo r at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to which th e measure applies. Measures with a 0 percent performance rate would not be counted. For an elig ible professional who reports fewer than 9 measures covering less than 3 NQS domains, the eligible prof essional would be subject to the MAV process, which would allow us to determine whether an eligible pr ofessional should have reported quality data codes for

additional measures and/or cove ring additional NQS domains. b. Changes to the Criterion for Satisfactory Reportin g of Individual Quality Measures via Registry for Individual Eligible Professionals for the 2014 PQRS Incentive In the CY 2013 PFS final rule with comment peri od, to maintain reporting criterion with which individual eligible professionals are familiar, we fi nalized the same satisfactory reporting criterion for individual eligible professionals to report individual quality measures via registry that we finalized in previous years: For the 12-month reporting period for the 2014 PQRS incentive, report at least 3 measures AND report each measure for at least 80 percent of the eligible professional’s Medicare Part B FFS patients seen during the reporting period to which th e measure applies. Measures with a 0 percent performance rate would not be counted (77 FR 69189). In the proposed rule, we proposed (78 FR 43359) to change this reporting criterion for individual eligible professionals reporting via registry for the 2014 PQRS incentive to the following: For the 12-month re porting period for the 2014 PQRS incentive, report at least 9 measures covering at least 3 of the NQS domains AND report each measure for at least 50 percent of the eligible professional’s Medicare Pa rt B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 per cent performance rate would not be counted (78 FR 43359). We solicited and received the following pub lic comments on the proposed changes to the criterion for the satisfactory reportin g of individual quality measures via registry for individual eligible professionals for the 2014 PQRS incentive:

### CMS-1600-FC 743

Comment : The majority of commenters supported ou r proposal to decrease the percentage of patients that must be reported via registry from 80 percent to 50 percent. The commenters supported our proposal specifically because it aligns with the option to report individual measures via the claims-based reporting mechanism. Response : We appreciate the commenters’ feedback and, based on the support received and for the reasons stated in the proposed rule (78 FR 43359), we are finalizing this proposal with regard to the percent threshold. Therefore, to meet the criteri a for satisfactory reporting for the 2014 PQRS incentive, an eligible professional reporting i ndividual quality measures via registry will be required to report each measure for at least 50 percent of the eligible pr ofessional’s Medicare Part B FFS patients seen during the reporting period to which the measure applies.

Comment : One commenter stated that we should not align the PQRS reporting criteria for reporting mechanisms other than the EHR-based reporti ng mechanisms with the reporting criteria for the EHR Incentive Program, as the objectives for the two programs are different. Response : We respectfully disagree. Although the standards and criteria for which the PQRS and EHR Incentive Program provide incentives and relieve eligible professionals from payment adjustments are different, the two programs are both dedicated to the promotion of EHR technology and the collection of quality data.

Comment : The majority of commenters opposed our proposal to increase the number of measures to be reported via registry from 3 measu res covering 1 NQS domain to 9 measures covering 3 NQS domains. Several of these commenters generall y opposed any proposal that would increase the number of measures to be reported via registry from 3 measures covering 1 NQS domain. Some of these commenters noted that they have b een successful at meeting the criteria for satisfactory reporting in the PQRS via registry in the past, and increasing the number of measures to be reported via registry would make it more difficult for these eligible professionals to meet the criteria for satisfactory reporting for the 2014 PQRS incentive. Other commenters urged CMS not to increase the criteria for satisfactory reporting until participation in PQRS increases, as the commenter s feared that increasing the criteria for satisfactory

### CMS-1600-FC 744

reporting in PQRS would discourage eligible professiona ls from participating in the PQRS. Still some of these commenters opposing this proposal noted that certa in eligible professionals did not have 9 measures covering 3 NQS domains for which to report. Response : We understand the commenters’ concerns about increasing the number of measures to be reported via registry from 3 measures cove ring 1 NQS domain to 9 measures covering 3 NQS domains. However, we believe it is important to colle ct data that provides a broad picture of the quality of care provided by an eligible professional, specifically since, as discussed in section K of this final rule with comment period, the Value-based Payment Modifi er will use participation in PQRS to determine upward, downward, and neutral adjustments based on physician performance. We also believe it is important to cover 3 NQS domains. As we noted ab ove and in the proposed rule (78 FR 43359), we believe that we have provided elig ible professionals with enough time to familiarize themselves with the reporting options for satisfactory reporting under the PQRS, particularly for the PQRS incentives, and thefore, we find this increase appropriate. For the commenters who urge us not to raise the satisfactory reporting criteria for the PQRS until participation in PQRS increases, we understand that, as discussed in this final rule below and in the 2011 PQRS and eRx Reporting Experience, participation in the PQRS has fluctuated around 25 percent among those eligible to participate in the PQRS. Indeed, it is one of our major goals to increase participation in the PQRS. While increasing the satisfactory repor ting threshold for the 2014 PQRS incentive may deter or discourage some eligible professionals from par ticipating, we believe that this increase to the satisfactory reporting threshold will not significantly de ter eligible professionals from participating in the PQRS. In particular, eligible professionals will be required to report PQRS qua lity measures data in 2014 to meet the criteria for satisfactory reporting for th e 2016 PQRS payment adjustment, which we believe will be an incentive for participation. In additio n, we note the reporting periods for the 2014 PQRS incentive and 2016 PQRS payment adjustment run concu rrently. Since eligible professionals will already be required to meet the criteria for satisfactory reporting for the 2016 PQRS payment adjustment, we believe these eligible professionals will also attemp t to report for the 2014 PQRS incentive regardless of

### CMS-1600-FC 745

whether we increase the measure threshold from 3 measures covering 1 NQS domain to 9 measures covering 3 NQS domains. For the commenters’ concerns about not having at least 9 PQRS measures covering 3 NQS domains for which to report via registry, we unde rstand the commenters concerns. While we are still finalizing our proposal to increase the number of indi vidual measures required to be reported via registry to meet the criteria for satisfactory reporting fo r the 2014 PQRS incentive to 9 measures covering 3 domains, to address the concern for those eligible pr ofessionals who fear they do not have 9 individual PQRS measures and/or measures covering at least 3 NQS domains applicable to their practice, we are modifying our proposal to allow eligible professiona ls to report fewer measures so that eligible professionals who do not have at least 9 PQRS measur es applicable to their pr actice can still meet this criteria for satisfactory reporting for the 2014 PQRS incentive by reporting 1-8 measures covering for which there is Medicare patient data. If an eligible professional does not have 9 applicable measures to report, the eligible professional must report on as many measures covering as many NQS domains (up to 3 NQS domains) as are applicable to his/her practice. For example, if an eligible professional only has 7 measures covering 2 NQS domains applicable to his/ her practice, he/she must report all 7 measures covering 2 NQS domains in order to meet the cr iteria for satisfactory reporting for the 2014 PQRS

incentive. It would not be suffici ent for the eligible professional to report on, for example, 6 measures covering 1 NQS domains. Given that change, we will analyze eligible professionals who report 1-8 measures using a Measures Application Validity (MAV) process (similar to the claims MAV process we discussed above) to ensure whether the eligible professionals could ha ve reported on the applicable measures. This is consistent with our practice for applying this process to the claims-based reporting option for eligible professionals to report individual measures. Specifically, if fewer than 9 measures and/or me asures covering fewer than 3 NQS domains apply to the eligible professional, an eligible professiona l must report 1-8 measures covering 1-3 NQS domains for which there is Medicare patient data. The MAV process will be triggered when an eligible

### CMS-1600-FC 746

professional reports on less than 9 measures. For example, if an eligible professional reports on 8 measures covering 3 NQS domains, the MAV process will be triggered to determine whether an eligible professional could have reported on an additional measure to report on a total of 9 measures covering 3 NQS domains. The 2014 registry MAV process that will determin e whether an eligible professional could have reported on more measures and/covering more NQS domains will be similar to the “clinical relation” test used in the 2013 claims MAV process. To get a better sense of how the 2014 registry MAV process will be implemented by CMS, a description of the “clini cal relation” test in the current 2013 claims MAV process is available at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/PQRS/Downloads/2013_PQRS_Measu reApplicabilityValidation_Docs_030413.zip . Please note that we will post a guidance document on the 20 14 registry MAV process, which will include a list

of the measure clusters that are used for the “clinical relation” test, prior to January 1, 2014 (the start of the 2014 reporting periods). We believe the changes we are finalizing will address commenters concerns, while still maintaining our general goal of increasing the meas ures reported to 9 measures covering 3 NQS domains. This also will increase the likelihood that more eligible professionals will be able to take advantage of this reporting option.

Comment : Several commenters supported our proposal to increase the number of measures to be reported via registry, as requiring an eligible professional to report on more measures would better capture the quality of care provided by an eligible professional. Response : We appreciate the commenter’s feedback w ith regard to the increase in measures. However, as discussed below, we are making a change in the final rule with regard to the applicable measures that must be reported under this satisfactory reporting criterion.

Comment : While several commenters generally supported our proposal to increase the number of measures to be reported via registry, the commenters urged CMS to provide a more gradual approach to increasing the number of measures that must be re ported via registry. These commenters suggested

### CMS-1600-FC 747

requiring the reporting of either 4 measures covering at least 1 NQS domain, 5 measures covering at least 2 NQS domains, or 6 measures covering at least 2 NQS domains. Response : We appreciate the commenters’ support for our desire to increase the number of measures to be reported via registry, as well as th eir alternative suggestions on how to increase the number of measures to be reported via registry. Wh ile we agree that a more gradual increase in the number of measures to be reported may be necessary for purposes of meeting the criteria for satisfactory reporting for the 2016 PQRS payment adjustment, sin ce 2016 would only be the second year in which an eligible professional could be subject to a PQRS payment adjustment, we do not believe this reasoning applies to satisfactory reporting criteria related to the 2014 PQRS incentive. For the 2014 PQRS incentive, as we stated with claims-based reportin g, the PQRS program has provided incentives for satisfactory reporting since 2007, and we believe 6 years is a reasonable amount of time to allow eligible professionals to become familiar with the requirements for earning a PQRS incentive. In fact, eligible professionals have traditionally been successful in mee ting the criteria for satisfactory reporting using the registry-based reporting mechanism. According to the 2011 PQRS and eRx Experience Report, 88 percent of eligible professionals reporting indi vidual measures using the registry-based reporting mechanism in 2011 met the criteria for satisfactory re porting for the 2011 PQRS incentive. Therefore, our concerns on gradually phasing in an increased reporting threshold for the 2016 PQRS payment adjustment does not apply here with the 2014 PQRS incentive. We believe it is appropriate to increase the number of measures to be reported via regist ry from 3 measures covering 1 NQS domain to 9 measures covering 3 NQS domains for the 2014 PQRS incentive. For the commenters’ suggested alternative criteria, while we understand the commenters’ concerns, we believe our interest in aligning the satis factory reporting criteria of individual measures via registry with the satisfactory reporting criteria of individual measures via EHR for the 2014 PQRS incentive outweighs the need for a gr adual increase in the number of measures required to be reported via registry.

### CMS-1600-FC 748

For the reasons stated above, we are finalizing at §414.90(h)(3) the following criterion for individual eligible professionals reporting individual PQRS quality me asures via registry for the 2014 PQRS incentive: For the 12-month reporting period for the 2014 PQRS incentive, report at least 9 measures covering at least 3 of the NQS domains, OR, if less than 9 measures covering at least 3 NQS domains apply to the eligible professional, repor t 1—8 measures covering 1-3 NQS domains for which there is Medicare patient data, AND report each measure for at least 50 percent of the eligible professional’s Medicare Part B FFS patients seen duri ng the reporting period to which the measure applies. Measures with a 0 percent performance rate will not be counted. Fo r an eligible professional who reports fewer than 9 measures covering less than 3 NQS domains, the eligible professional would be subject to the MAV process, which would allow us to determine whether an eligible professional should have reported on additional measures and/or measures covering additional NQS domains. c. Changes to the Criterion for Satisfactory Reporting of Measures Groups via Claims for Individual Eligible Professionals for the 2014 PQRS Incentive In the CY 2013 PFS final rule with comment pe riod, we finalized the following criteria for satisfactory reporting for individual eligible professi onals to report measures groups via claims: Report at least 1 measures group AND report each measures group for at least 20 Medicare Part B FFS patients. Measures groups containing a measure with a 0 per cent performance rate will not be counted (77 FR 69192). Since finalizing this criterion, we publishe d and analyzed the 2011 PQRS and eRx Experience Report, which provides a summary of PQRS reporti ng trends from 2007 through 2011, to determine where we may work to further streamline the reportin g options available under the PQRS. The PQRS and eRx Experience Report stated that the number of elig ible professionals who participated via claims-based measures groups reporting mechanism grew more than three-fold between 2008 and 2011. However, according to Appendix 8 of the PQRS and eRx E xperience Report titled “Eligible Professionals who Participated by Reporting Measures Groups through th e Claims Reporting Mechanism for the Physician Quality Reporting System, by Specialty (2008 to 20 11),” only 4,472 eligible professionals used this reporting option. Meanwhile, the Experience Report further shows that the option to report measures

### CMS-1600-FC 749

groups via registry has grown at an even faster rate with 12,894 participants in 2011. Therefore, in an effort to streamline the reporting options available unde r the PQRS and to eliminate reporting options that are not widely used, we proposed to remove this satisfactory reporting criterion for the 2014 PQRS incentive (78 FR 43359). We solicited and receive d the following public comments on this proposal:

Comment : Some commenters supported our proposal to eliminate the option to report measures groups via claims for the 2014 PQRS incentive in an e ffort to streamline the reporting options available under the PQRS. Response : We appreciate the commenters’ feedback and are finalizing this proposal.

Comment : Several commenters opposed our proposal to eliminate the option to report measures groups via claims for the 2014 PQRS incentive. Comment ers stressed the need to maintain the claimsbased reporting option, as some commenters are weary that moving away from the claims-based reporting mechanism will eliminate a free way to report qua lity measures under the PQRS (as most registries charge a fee to report PQRS quality measures data on beha lf of its eligible professionals to CMS). Other commenters stressed the need to maintain a wide range of reporting options. Response : We understand the commenters’ desire to ha ve free options to report under the PQRS. However, we do not believe it is necessary to main tain this reporting option, because an eligible professional may still use the free option of claims-b ased reporting to report individual quality measures for the 2014 PQRS incentive. In addition, we note th at, while many qualified registries charge a fee for use of the registry, not all registries may charge a f ee to use the registry to report quality measures for the PQRS. As you can see, although we are eliminati ng the option to report measures groups via claims, there are still ways to participat e in the PQRS that are free. For the commenters’ desire to keep a wide range of PQRS reporting options available to eligible professionals, as we stated in the proposed rule (78 FR 43359), we simply do not see the need to keep this option available since this is not a widely used reporting option. We note that, although we are eliminating this reporting option, there are several ot her ways to participate in the PQRS either as an individual eligible professional or as part of a group practice under the GPRO. In fact, as we describe

### CMS-1600-FC 750

below, we are adding the option to earn a 2014 PQ RS incentive based on an eligible professional’s satisfactory participation in a qualif ied clinical data registry. For the reasons stated above, we are finalizing our proposal to eliminate the following criteria for satisfactory reporting for individual eligible professi onals to report measures groups via claims for the 2014 PQRS incentive: Report at least 1 measures group AND report each measures group for at least 20 Medicare Part B FFS patients. Measures groups contai ning a measure with a 0 percent performance rate will not be counted. Please note that, as a result of our final decision to remove this satisfactory reporting criterion, the only manner in which an eligible prof essional will be able to report PQRS measures groups are via registry. 5. Criteria for Satisfactory Reporting for the 2016 PQRS Payment Adjustment for Individual Eligible Professionals using the Claims and Registry Reporting Mechanisms Section 1848(a)(8) of the Act provides that fo r covered professional services furnished by an eligible professional during 2015 or any subsequent year, if the eligible professional does not satisfactorily report data on quality measures for covered professional services for the quality reporting period for the year, the fee schedule amount for servi ces furnished by such professional during the year shall be equal to the applicable percent of the f ee schedule amount that would otherwise apply to such services. For 2016 and subsequent years, the applicable percent is 98.0 percent. In the CY 2013 PFS final rule, we finalized seven different criteria for the satisfactory reporting by individual eligible professionals of data in PQRS quality measures for the 2016 PQRS payment adjustment (see 77 FR 69200-69204 and Table 91 at 77 FR 69194). In the proposed rule, we proposed (78 FR 43360) to eliminate two criteria, revise anot her, and include two additional criteria (based on two of the existing criteria). Specifically, corresponding with our proposal (78 FR 43360) to eliminate a reporting criterion for the 2014 PQRS incentive to streamline the program and eliminate criteria for reporting options that are not widely used, we proposed to remove the following criterion we previously finalized for the CY 2016 payment adjustment for individual eligible prof essionals reporting measures groups through claims (77

### CMS-1600-FC 751

FR 69200 and Table 91, 77 FR 69164): Report at least 1 measures group AND report each measures group for at least 20 Medicare Part B FFS patients (Measures groups containing a measure with a 0 percent performance rate will not be counted). We solicited and received th e following public comments on this proposal:

Comment : Some commenters supported our proposal to eliminate the option to report measures groups via claims for the 2016 PQRS payment adjustment in an effort to streamline the reporting options available under the PQRS. Response : We appreciate the commenters’ feedback and, based on the commenters’ support and the reasons stated above, are finalizing this proposal.

Comment : Several commenters opposed our proposal to eliminate the option to report measures groups via claims for the 2016 PQRS payment adjustment . Commenters stressed the need to maintain the claims-based reporting option, as some commenters ar e weary that moving away from the claims-based reporting mechanism will eliminate a free way to report quality measures under the PQRS (as most registries charge a fee to report PQRS quality measur es data on behalf of its eligible professionals to CMS). Response : Although we understand the commenters’ desi re to have free options to report under the PQRS, we do not believe it is necessary to mainta in this reporting option, because, as is also the case for reporting for the 2014 PQRS incen tive, an eligible professional may still use the free option of claimsbased reporting to report individual quality measu res for the 2016 PQRS payment adjustment. In addition, we note that, while many qualified registries charge a fee for use of the registry, not all registries may charge a fee to use the registry to report qua lity measures for the PQRS. Although we are finalizing our decition to eliminate the option to report measures groups via claims, there are still ways to participate in the PQRS that are free. As for the commenters’ desire to keep a wide range of PQRS reporting options available to eligible professionals, we simply do not see the need to keep this option available since this is not a widely used reporting option. We note that, although we are eliminating this reporting option, there are

### CMS-1600-FC 752

several other ways to participate in the PQRS either as an individual eligible professional or as part of a group practice under the GPRO. In fact, as we descri be below, we are adding the option to avoid the 2016 PQRS payment adjustment based on an eligib le professional’s satisfactory participation in a qualified clinical data registry. In summary, we are modifying §414.90(j)(3) to reflect our final decision to eliminate the following criteria for satisfactory reporting for indivi dual eligible professionals to report measures groups via claims for the 2016 PQRS payment adjustme nt: Report at least 1 measures group AND report each measures group for at least 20 Medicare Part B FFS patie nts. Measures groups containing a measure with a 0 percent performance rate will not be counted. Pl ease note that, since we are removing this reporting criterion, the only manner under which an eligible pr ofessional would be able to report a PQRS measures group would be via registry. We also proposed (78 FR 43360) to remove the following criterion we previously finalized for the 2016 PQRS payment adjustment for individual e ligible professionals reporting individual measures through a qualified registry: Report at least 3 measures, AND report each measure for at least 80 percent of the eligible professional’s Medicare Part B FFS patients seen during the reporting period to which the measures applies. Measures with a 0 percent perform ance rate will not be counted. We solicited and received the following public comments on this proposal:

Comment : While several commenters supported our proposal to increase the number of measures to be reported via registry, these commenters gene rally did not support eliminating this reporting criterion. Some commenters did not support eliminati ng this reporting criterion as eligible professionals have previously met the criteria for satisfactory repor ting using this criterion and therefore do not want to modify they manner in which they report. Othe r commenters expressed concern that there are still eligible professionals who do not have 3 measures applicable to their practice. These commenters therefore suggested that this criterion be modified to require the reporting of only 1 measure covering 1 NQS domain for the 2016 PQRS payment adjustment, si milar to the criterion that was finalized for the

### CMS-1600-FC 753

2015 PQRS payment adjustment (77 FR 69201), as so me commenters are concerned that there are still eligible professionals who do not have 3 measures applicable to their practice. Response : We understand the commenters’ concerns regarding eliminating this reporting criterion. Although we still desire to move toward s the reporting of more measures, we understand that eligible professionals may need another year to adjust to the reporting of additio nal measures. We believe it is pertinent to allow time for eligible professionals to adjust to the reporting of additional measures for purposes of the 2016 PQRS payment adjustment as opposed to the 2014 PQRS incentive, because earning a 2014 PQRS incentive results in a positive payment adjustment whereas beingsubject to the 2016 PQRS payment adjustment results in a downward payment adjustment. Therefore, based on the concerns expressed by commenters, we are not finalizing our proposal to eliminate this reporting criterion for the 2016 PQRS payment adjustment. We note, however, that it is our intention to move towards the reporting of 9 measures covering at least 3 NQS domains for the 2017 PQRS payment adjustment. Since we are maintaining this satisfactory repor ting criterion under the PQRS, and given that, as noted above, we are finalizing our proposal to redu ce the percentage threshold of reporting measures via registry for purposes of the 2014 PQRS incentive fro m 80 to 50 percent, we are finalizing the same change for this reporting criterion for the 2016 PQRS pa yment adjustment. That is, to coincide with the registry reporting criterion for the 2014 PQRS incentive, we are also lowering the percentage threshold for the reporting of measures at least 3 measures vi a registry for the 2016 PQRS payment adjustment from 80 to 50 percent. We do not believe this cha nge negatively affects eligib le professionals who intend to report using this reporting cr iterion as this modification re duces reporting burden on eligible professionals. In addition, we note that, since th e percentage threshold for the 2014 PQRS incentive typically coincides with the percentage threshold for the 2016 PQRS payment adjustment, it was foreseeable that we would lower the percentage thr eshold of reporting measures via registry for the 2016 PQRS payment adjustment from 80 to 50 percent since we proposed to lower the percentage threshold for the 2014 PQRS incentive.

### CMS-1600-FC 754

For the commenters’ who expressed concern that there are still eligible professionals who do not have 3 measures applicable to their practice, we are further modifing this satisfactory reporting criterion t o allow EPs to report 1-2 applicable measures if 3 meas ures are not applicable to the eligible professional. As a result, and consistent with the other similar crite ria we are finalizing in this final rule with comment for the 2014 PQRS incentive, we will apply a re gistry MAV process for the 2016 PQRS payment adjustment. For purposes of this reporting criterion, the registry MAV process will be triggered when an eligible professional reports on less than 3 measures c overing 1 NQS domain. For example, if an eligible professional reports on 1—2 measures, the MAV process will be triggered to determine whether an eligible professional could have reported on at least 3 measures covering 1 NQS domain. This registry MAV process that will determin e whether an eligible professional could have reported on more measures will be similar to the “clin ical relation” test used in the 2013 claims MAV process. To get a better sense of how the registry MAV process for the 2016 PQRS payment adjustment will be implemented by CMS, a description of the “clin ical relation” test in the current 2013 claims MAV process is available at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/PQRS/Downloads/2013_PQRS_Measu reApplicabilityValidation_Docs_030413.zip . Please note that we will post a guidance document on the registry MAV process for the 2016 PQRS payment adjustment, which will include a list of the measure clus ters that are used for the “clinical relation” test, prior to January 1, 2014 (the start of the 2014 reporting periods). In summary, for the reasons we noted above and in response to comments, we are not eliminating the following reporting criterion: Report at least 3 measures, AND report each measure for at least 80 percent of the eligible professional’s Medicare Pa rt B FFS patients seen during the reporting period to which the measures applies. Measures with a 0 percen t performance rate will not be counted. Instead, we are retaining this reporting criterion for the 2016 paym ent adjustment for individual eligible professionals reporting individual measures through a qualified registry but modifying this reporting criterion in the following manner: For the 12-month reporting period for the 2016 PQRS payment adjustment, report at least 3 measures covering at least 1 of the NQS domains, OR, if less than 3 measures apply to the eligible

### CMS-1600-FC 755

professional, report 1—2 measures covering 1 NQS dom ain for which there is Medicare patient data, AND report each measure for at least 50 percent of the eligible professional’s Medicare Part B FFS patients seen during the reporting period to which th e measure applies. Measures with a 0 percent performance rate would not be counted. For an elig ible professional who reports fewer than 3 measures covering 1 NQS domain via the registry-based reporti ng mechanism, the eligible professional would be subject to the MAV process, which would allow us to determine whether an eligible professional should have reported on additional measures. Finally, to maintain some consistency and to ot herwise align with the criteria we proposed for the 2014 PQRS incentive for individual eligible professiona ls, we proposed two other criteria for satisfactory reporting by individual eligible professionals for th e 2016 PQRS payment adjustment using the claims reporting mechanism (78 FR 43360). We proposed (7 8 FR 43360) the following criterion for reporting individual measures via claims by individual e ligible professionals for the 2016 PQRS payment adjustment: For the 12-month reporting period for the 2014 PQRS incentive, report at least 9 measures, covering at least 3 of the National Quality Strategy do mains, OR, if less than 9 measures covering at least 3 NQS domains apply to the eligib le professional, report 1–8 measures, and report each measure for at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent perform ance rate would not be c ounted.. We solicited and received the following comment on this proposed criterion:

Comment : One commenter stressed the importance of aligning the reporting criteria for the 2014 PQRS incentive with the reporting criteria for the 20 16 PQRS payment adjustment, so that eligible professionals would be able to use one reporting option for the 2014 PQRS incentive and the 2016 PQRS payment adjustment. Response : We appreciate the commenters’ support rega rding our desire to align reporting options for the 2014 PQRS incentive and 2016 PQRS payment adjustment. Based on the reasons previously stated and the positive feedback to align reporting options for the 2014 PQRS incentive and 2016 PQRS payment adjustment, we are finalizing the following criterion for reporting individual measures via claims

### CMS-1600-FC 756

by individual eligible professionals for the 2016 PQRS payment adjustment: Report at least 9 measures covering at least 3 NQS domains, OR, if less than 9 measures covering at least 3 NQS domains apply to the eligible professional, report 1—8 measures c overing 1—3 NQS domains, AND report each measure for at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent performan ce rate would not be coun ted. For an eligible professional who reports fewer than 9 measures covering at least 3 NQS domains via the claims-based reporting mechanism, the eligible professional would be subject to the MAV process, which would allow us to determine whether an eligible professional s hould have reported quality data codes for additional measures and/or covering additional NQS domains. With respect to an eligible professional who repor ts on less than 9 measures and/or covering less than 3 NQS domains, the eligible professional must report on ALL measures covering as many domains as are applicable to the eligible professional’s practice. 

### In other words, with respect to an eligible professional who does not have 9 measures covering 3 NQS doma ins to report, the EP must report 1-8 measures, as app licable, and hit the maximu m number of domains. For example, if an eligible professional has only 7 measures covering at least 3 NQS domains applicable to the eligible professional’s practice, the eligible professional must report on all 7 measures covering at least 3 NQS

domains. We also proposed (78 FR 43360) the following criterion for reporting individual measures via qualified registry by individual elig ible professionals for the 2016 PQRS payment adjustment: For the 12- month reporting period for the 2016 PQRS payment adjustment, report at least 9 measures covering at least 3 of the NQS domains and report each measure fo r at least 50 percent of the eligible professional’s Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent performance rate would not be coun ted. We solicited and r eceived the following public comment on this proposed criterion:

### CMS-1600-FC 757

Comment : One commenter stressed the importance of aligning the reporting criteria for the 2014 PQRS incentive with the reporting criteria for the 20 16 PQRS payment adjustment, so that eligible professionals would be able to use one reporting option for the 2014 PQRS incentive and the 2016 PQRS payment adjustment. Response : We appreciate the commenters’ feedback and are aligning reporting options for the 2014 PQRS incentive and 2016 PQRS payment adjustment to report individual measures via registry by individual eligible professionals.

Comment : The majority of commenters supported ou r proposal to decrease the percentage of patients that must be reported via registry from 80 percent to 50 percent. The commenters supported our proposal specifically because it aligns with the option to report individual measures via the claims-based reporting mechanism. Response : We appreciate the commenters’ feedback and, based on the support received and for the reasons stated in the proposed rule (78 FR 43360), we are finalizing this proposal with regard to the percent threshold. Therefore, to meet the criteri a for satisfactory reporting for the 2016 PQRS payment adjustment, an eligible professional reporting individua l quality measures via registry will be required to report each measure for at least 50 percent of the eligible professional’s Medicare Part B FFS patients seen during the reporting period to which the measure applies.

Comment : One commenter stated that we should not align the PQRS reporting criteria for reporting mechanisms other than the EHR-based reporti ng mechanisms with the reporting criteria for the EHR Incentive Program, as the objectives for the two programs are different. Response : We respectfully disagree. Although the standards and criteria for which the PQRS and EHR Incentive Program provide incentives and relieve eligible professionals from payment adjustments are different, the two programs are both dedicated to the promotion of EHR technology and the collection of quality data.

Comment : The majority of commenters opposed our proposal to increase the number of measures to be reported via registry from 3 measu res covering 1 NQS domain to 9 measures covering 3

### CMS-1600-FC 758

NQS domains. Several of these commenters generall y opposed any proposal that would increase the number of measures to be reported via registry from 3 measures covering 1 NQS domain. Some of these commenters noted that they have b een successful at meeting the criteria for satisfactory reporting in the PQRS via registry in the past, and increasing the number of measures to be reported via registry would make it more difficult for these eligible professionals to meet the criteria for satisfactory reporting for the 2016 PQRS payment adjustment. Other comment ers urged CMS not to increase the criteria for satisfactory reporting until particip ation in PQRS increases, as the co mmenters feared that increasing the criteria for satisfactory reporting in PQRS would di scourage eligible professionals from participating in the PQRS. Still some of these commenters opposing this proposal noted that certain eligible professionals did not have 9 measures covering 3 NQS domains for which to report. These commenters suggested requiring the reporting of either 4 measu res covering at least 1 NQS domain, 5 measures covering at least 2 NQS domains, or 6 measures covering at least 2 NQS domains. Many of these commenters suggested requiring the reporting of only 1 measure covering 1 NQS domain for the 2016 PQRS payment adjustment, similar to the criterion that was finalized for the 2015 PQRS payment adjustment (see Table 91 at 77 FR 69194), as some commenters are concerned that there are still eligible professionals who do not have 3 measures applicable to their practice. Response : We understand the commenters’ concerns. As stated above, we are not finalizing our proposal to eliminate the option to report 3 measures covering 1 NQS domain (and further modifying it to allow the reporting of 1-2 meaures if 3 are not appli cable). This should address some of the concerns raised regarding the proposed satisfactory criteri on described above regarding increasing and moving away from reporting 3 meausures. That also afford s varying levels of reporting criteria from which to choose – particularly as participation increased. Theref ore, eligible professionals will, at least for the 2016 PQRS payment adjustment, have the option to use an alternative, less stringent reporting criterion to generally report 3 individual quality measures for the 2016 PQRS payment adjustment via registry in lieu

of this criterion.

### CMS-1600-FC 759

As for this criterion and commenters’ concerns about not having at least 9 PQRS measures covering 3 NQS domains, we are finalizing a modificati on to our proposal to allow eligible professionals to report fewer measures so that eligible professionals who do not have at least 9 PQRS measures or measures covering at least 3 NQS domains applicable to their practice. Specifically, if fewer than 9 measures covering less than 3 NQS domains apply to the eligible professional, an eligible professional must report 1-8 measures covering 1-3 NQS domains for which there is Medicare patient data. This is

consisten with what we are finalizi ng with regard to certain 2014 PQRS incentive criteria. Similarly, the MAV process will be triggered when an eligible professional reports on less than 9 measures. For example, if an eligible professional reports on 8 measures covering 2 NQS domains, the MAV process will be triggered to determine whether an eligib le professional could have reported on an additional measure to report on at least 9 measures covering 2 or 3 NQS domains. In summary, we are finalizing at §414.90(j)(3) th e following criterion for reporting individual measures via qualified registry by individual e ligible professionals for the 2016 PQRS payment adjustment: Report at least 9 measures covering at least 3 of the NQS domains, OR, if less than 9 measures covering at least 3 NQS domains apply to the eligible professional, report 1—8 measures covering 1-3 NQS domains for which there is Medi care patient data, AND report each measure for at least 50 percent of the eligible professional’s Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent performance rate will not be counted. For an eligible professional who reports fewer than 9 measures, the eligible prof essional will be subject to the MAV process, which will allow us to determine wh ether an eligible professi onal should have reported

on additional measures and/or measure s covering additional NQS domains. Please note that if an individual eligible professi onal were to meet any of the criteria for satisfactory reporting for the 2014 PQRS incentive, th e individual eligible professional would meet the requirements for satisfactory reporting for the 2016 PQ RS payment adjustment (note, however, that the reverse would not necessarily be true since there are additional criteria for satisfactory reporting for the 2016 PQRS payment adjustment that would not apply to the 2014 PQRS incentive). As we continue to

### CMS-1600-FC 760

implement the PQRS payment adjustment and fully implement the value-based payment modifier in 2017, it is our intent to ramp up the criteria for satisfactory reporting for the 2017 PQRS payment adjustment to be on par or more stringent than th e criteria for satisfactory reporting for the 2014 PQRS

incentive. 6. Satisfactory Participation in a Qualified Clinical Data Registry by Individual Eligible Professionals Section 601(b) of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112–240, enacted January 2, 2013) amends section 1848(m)(3) of the Act, by redesignating para graph (D) as subparagraph (F) and adding new subparagraph (D), to provide for a new standard for individual eligible professionals to satisfy the PQRS beginning in 2014, based on satis factory participation in a qualified clinical data registry. In the CY 2014 PFS proposed rule (78 FR 43360), we set forth our proposals for implementing this provision, including the proposed requirements for qualified clinical data registries and our proposals for individual eligible professionals to satisfactorily participate in a qualified clinical data registry for the 2014 PQRS incentive and 2016 PQRS payment adjustme nt. Below, we address the final requirements related to satisfactory participation in a qualified clini cal data registry by individual eligible professionals. a. Definition of a Qualified Clinical Data Registry Under section 1848(m)(3)(D) of the Act, as am ended and added by section 601(b)(1) of the ATRA, for 2014 and subsequent years, the Secretary shall treat an eligible professional as satisfactorily submitting data on quality measures if, in lieu of re porting measures under subsection (k)(2)(C), the eligible professional is satisfactorily participating, as determined by the Secretary, in a qualified clinical data registry for the year. Section 1848(m)(3)(E) of the Act, as added by section 601(b)(1) of the ATRA, authorizes the Secretary to define a qualified clinical data registry under the PQRS. Specifically, the Secretary is required to establish requirements for an entity to be considered a qualified clinical data registry (including that the entity provide the Secretar y with such information, at such times, and in such manner, as the Secretary determines necessary to carry out the provision). In establishing such requirements, the Secretary must take certain factors into consideration.

### CMS-1600-FC 761

Based on CMS’ authority to define a qualified c linical data registry under section 1848(m)(3)(E) of the Act, as added by section 601(b) of the ATRA , and accounting for the considerations addressed in section 1848(m)(3)(E)(ii) of the Act and for the reasons stated in the CY 2014 PFS proposed rule (78 FR 43361), we proposed to modify §414.90(b) to add a proposed definition for a qualified clinical data registry. Specifically, we proposed to define a “qua lified clinical data registry” for purposes of the PQRS as a CMS-approved entity (such as a registry, certificati on board, collaborative, etc.) that collects medical and/or clinical data for the purpose of patient and disease tracking to foster improvement in the quality of care furnished to patients. First, we proposed that a qualified clinical data registry must be able to submit quality measures data or results to CMS for purposes of demonstrating th at, for a reporting period, its eligible professionals have satisfactorily participated in PQRS. We proposed that a qualified clinical data registry must have in place mechanisms for the transparency of data elem ents and specifications, risk models, and measures. We solicited and received the following public comme nt on this proposed aspect of the definition we proposed for a qualified clinical data registry:

Comment : Some commenters opposed our proposed re quirement that an entity who seeks to become a qualified clinical data registry must be ab le to submit quality measures data or results to CMS for purposes of demonstrating that, for a reporting peri od, its eligible professionals have satisfactorily participated in PQRS. The commenters were gene rally opposed to requiring qualified clinical data registries to report on measures on behalf of its pa rticipating eligible professionals. These commenters believed that CMS should not require that a qualified c linical data registry be able to report on quality measures data if a clinical data registry is ab le to perform other important functions, such as benchmarking. Response : We appreciate the commenters’ feedback but respectfully disagree. We believe possessing the ability to submit quality measures data to CMS is an essential, not optional, aspect of a qualified clinical data registry. We believe collec ting quality measures data from a qualified clinical data registry is essential, particularly so that the data r eceived could be compared against eligible professionals

### CMS-1600-FC 762

participating in PQRS using other reporting options to determine appli cation of an upward, downward, or neutral adjustment under the Value-based Payment Modifier. Second, with regard to the consideration under section 1848(m)(3)(E)(ii)(II) of the Act, as added by section 601(b) of the ATRA that allows the subm ission of data from participants for multiple payers, we proposed that the data a qualified clinical data registry submitted to CMS for purposes of demonstrating satisfactory particip ation be quality measures data on multiple payers, not just Medicare patients. We solicited and received the followi ng public comment on this proposed aspect of our proposed definition of a qualif ied clinical data registry:

Comment : Several commenters supported our proposal to allow the reporting of quality measures data on multiple payers, not just Medicare patients. Response : We appreciate the commenters’ positive feedback and agree. Therefore, we are finalizing our proposal to include in the definition of a qualified clinical data registry the requirement that the data a qualified clinical data registry submitte d to CMS for purposes of demonstrating satisfactory participation be quality measures data on mu ltiple payers, not just Medicare patients.

Comment : Some commenters were weary of collectin g quality measures data on multiple payers. One of the commenters expressed concern that this co uld compel eligible professionals to collect and submit to a qualified clinical data re gistry patient data on multiple payers with no plan for utilizing the non-Medicare data or informing other payers that quality measure data have been collected on their patients. Response : We respectfully disagree with the commenters. Please understand that, although the PQRS is a pay-for-reporting program, the data collected under the PQRS is used to measure performance and the quality of care an eligible professional provides. In fact, as specified in this final rule, the data collected under the PQRS reported by qualified c linical data registries will be used to measure performance of certain eligible professionals under the Value-based Payment Modifier. Third, with regard to the consideration u nder section 1848(m)(3)(E)(ii)(III) of the Act, as added by section 601(b) of the ATRA, that a qualified clinical data registry provide timely performance reports

### CMS-1600-FC 763

to participants at the individual participant level, we proposed that a qualified clinical data registry must provide timely feedback at least quarterly on the measures for which the qualified clinical data registry would report on the individual elig ible professional’s behalf for purposes of the eligible professional meeting the criteria for satisfactory participation under PQRS. We solicited and received the following public comment on this proposal:

Comment : Some commenters supported our proposal to re quire a qualified clinical data registry to provide timely feedback at least quarterly on the m easures for which the qualified clinical data registry would report on the individual elig ible professional’s behalf for purposes of the eligible professional meeting the criteria for satisfactory participation under PQRS. However, other commenters expressed concern with this proposal, as it is costly and res ource-intensive to provide quarterly feedback to all eligible professionals participati ng in a qualified clinical data registry. Some commenters requested clarification on the meaning of providing timely feedb ack at least quarterly on the measures for which the qualified clinical data registry wo uld report on the individual eligible professional’s behalf for purposes of the eligible professional meeting the criteria fo r satisfactory participation under PQRS. These commenters asked whether certain registries that allow users to generate reports on an “on demand” basis rather than directly pushing out feedback reports to its participate eligible professionals would meet the requirement of providing timely feedback at least quarterly to its eligible professionals. Response : We appreciate the commenters’ support, as well as concerns regarding this proposal. We understand the cost and resources a qualified clinical data registry would undergo to provide quarterly feedback to its participating eligible professionals. However, regardless of the cost, we believe that the ability to provide timely and frequent feedback to participating eligible professionals is critically important to fostering quality care. Please note that we currently require traditional qualified registries to provide at least 2 feedback reports to its participati ng eligible professionals per year. Since we view a qualified clinical data registry as an entity that is mo re robust than a traditional qualified registry and goes further to drive the quality of care provided to patie nts than only reporting quality measures data for the PQRS, we believe that requirements for an entity to become a qualified clinical data registry should be

### CMS-1600-FC 764

more stringent than the requirements for a registry to be qualified under the PQRS. Therefore, we believe that a qualified clinical data registry should provide its participating eligible professionals with more than 2 feedback reports each year in which the clinical data registry is qualified. While we will not require a qualified clinical data registry to provide quarterly feedback reports, we are still requiring that a qualified clinical data registry provide at least 4 feedback re ports to each of its particip ating eligible professionals during the year in which the clinical data registry is qu alified (that is, if a qualified clinical data registry is qualified to report quality measures da ta for reporting periods occurring in 2014, the qualified clinical data registry must provide each participating eligib le professional with at least 4 feedback reports in 2014). We understand that some entities do not directly send feedback reports to its participating eligible professionals. Rather, these entities have feedback repor ts that are readily available for viewing at any time via the web or other communication mechanism. As one commenter specified, certain registries allow users to generate reports on an “on demand” basi s rather than directly pushing out feedback reports to its participating eligible professi onals. We note that this would fu lfill the requirement that an entity seeking to be a qualified clinical data registry provide each participating eligible professional with at least 4 feedback reports per year. Fourth, to address section 1848(m)(3)(E)(ii)(IV) of the Act, as added by section 601(b) of the ATRA, regarding whether a qualified clinical data re gistry supports quality improvement initiatives for its participants, we proposed (78 FR 43 362) to require that a qualified clin ical data registry possess a method to benchmark the quality of care measures an eligible professional provides with that of other eligible professionals performing the same or similar functi ons. Benchmarking would require that a qualified clinical data registry provide metrics to compare th e quality of care its participating eligible professional provides. For example, the National Committee fo r Quality Assurance (NCQA) provides national and regional benchmarks for certain measures. Adoptin g benchmarks such as those provided by NCQA could serve to satisfy this requirement.

### CMS-1600-FC 765

In addition to the comments received on our pro posed definition of a qualified clinical data registry, we received the following general comments on the implementation of this new qualified clinical data registry option:

Comment : Several commenters supported the addition of the option to meet the criteria for satisfactory participation in a qualif ied clinical data registry for the PQRS. However, some commenters opposed this new option. Commenters were concerned that participation in a qualified clinical data registry requires considerable r esources, ranging from subscription fees to the expertise of clinical personnel to abstract and report data. Response : We understand the commenters’ concerns rega rding the expense of participating in a qualified clinical data registry. However, we note that it is voluntary for eligible professionals participate in the PQRS using a qualified clinical data registry. Rather, it is one of several reporting mechanisms that may be used to report quality measures data under the PQRS.

Comment : One commenter generally opposed the impl ementation of the option to satisfactorily participate in a qualified clinical data registry fo r purposes of the PQRS. The commenter stressed that adding another reporting option would add to the complexity of the program. Response : We understand the commenters’ concerns re garding adding complexity to the PQRS. Indeed, we have worked to streamline the PQRS to eliminate complexity in the program. However, under section 1848(m)(3)(D) of the Act, we are required to pr ovide for a new standard for individual eligible professionals to satisfy the PQRS beginning in 2014, based on satisfactory participation in a qualified clinical data registry. Furthermore, we disagree with the commenter that this new qualified clinical data registry reporting option will add complexity to th e PQRS, as this new option provides more flexibility than all other PQRS reporting options. For example, as explained in further detail in the PQRS measures section below, if reporting via a qualified clinical data registry, an eligible professional is not required to report on measures within the PQRS measure set. In summary, we are amending §414.90(b) to define a qualified clinical data registry as a CMSapproved entity that has self-nominated and successful ly completed a qualification process that collects

### CMS-1600-FC 766

medical and/or clinical data for the purpose of patie nt and disease tracking to foster improvement in the quality of care provided to patients. A qualified c linical data registry must perform the following

functions: (1) Submit quality measures data or results to CMS for purposes of demonstrating that, for a reporting period, its eligible professi onals have satisfactorily participat ed in PQRS. A qualified clinical data registry must have in place mechanisms for the tr ansparency of data elements and specifications, risk models, and measures. (2) Submit to CMS, for purposes of demonstra ting satisfactory participation, quality measures data on multiple payers, not just Medicare patients (3) Provide timely feedback, at least four times a year, on the measures at the individual participant level for which the qualifie d clinical data registry reports on the eligible professional’s behalf for purposes of the individual eligible professional’s sa tisfactory participation in the clinical quality data registry. (4) Possess benchmarking capacity that measures the quality of care an eligible professional provides with other eligible professionals perform ing the same or similar functions. Please note that it is possible for an entity to serve as both a traditional, qualified registry or a data submission vendor and a qualified clini cal data registry under the PQRS. b. Requirements for a Qualified Clinical Data Registry As we noted above, we are required, under section 1848(m)(3)(E)(i) of the Act, to establish requirements for an entity to be considered a qualifie d clinical data registry. Such requirements shall include a requirement that the entity provide the Secret ary with such information, at such times, and in such manner, as the Secretary determines necess ary to carry out this subsection. Section 1848(m)(3)(E)(iv) of the Act, as added by section 601(b ) of the ATRA, requires CMS to consult with interested parties in carrying out this provision.

### CMS-1600-FC 767

Under this authority to establish the requiremen ts for an entity to be considered a qualified clinical data registry, we proposed (78 FR 43362) the following requirements that an entity must meet to serve as a qualified clinical data registry under the PQRS:

Comment : Some commenters generally supported the st ringent requirements we proposed for an entity to become a qualified clinical data registry. Response : We appreciate the commenters’ support for our proposals. We proposed (78 FR 43362) the following require ments to ensure that the entity seeking to become a qualified clinical data registry is well-established:

● Be in existence as of January 1 the year prior to the year for which the entity seeks to become a qualified clinical data registry (for example, January 1, 2013, to be eligible to participate for purposes of data collected in 2014). This proposed requirement is also required of a traditional qualified registry. We solicited and received the following pub lic comments on this proposed requirement:

Comment : While some commenters generally supported this proposal as it help ensures that entities seeking to become qualified clinical data re gistries are established entities with experience in driving quality improvement in healthcare, a few comm enters opposed our proposed requirement that, to become a qualified clinical data registry an entity must be in existence as of January 1 the year prior to the year for which the entity seeks to become a qualified c linical data registry (for example, January 1, 2013, to be eligible to participate for purposes of data co llected in 2014). The commenters noted that this may alienate new and developing entities that already perf orm the functions required of a qualified clinical data registry. Response : We understand that finalizing this requi rement may exclude new entities that could perform the functions we require of a qualified clinical data registry. However, as we noted in the CY 2014 PFS proposed rule (78 FR 43362), we believe it is important for an entity to test out its business practices to ensure that the practices it adopts truly fo ster the improvement of quality care prior to seeking to become a qualified clinical data registry. We belie ve that entities that have been in existence for less than 1 year prior to the year for which the entity seeks to become a qualif ied clinical data registry have

### CMS-1600-FC 768

not had an adequate opportunity to do so. We believe our reasons for proposing this requirement outweigh the commenters’ concerns. Therefore, we ar e finalizing this proposal. For an entity to become qualified for a given year, the entity must be in existe nce as of January 1 the year prior to the year for which the entity seeks to become a qualified clinical data registry (for example, January 1, 2013, to be eligible to participate for purpo ses of data collected in 2014).

● Have at least 100 clinical data registry particip ants by January 1 the year prior to the year for which the entity seeks to submit clinical quality meas ures data (for example, January 1, 2013, to be eligible to participate under the program with regard to data collected in 2014). Please note that not all participants would be required to pa rticipate in PQRS (78 FR 43362).

We solicited and received the followi ng public comments on this proposal:

Comment : Some commenters opposed this proposed requirement that an entity have at least 100 participants, because the commenters believe this requirement would effectively exclude smaller registries that perform important functions that provi de for the advancement of quality care. Commenters felt that this proposed requirement unfairly favor s larger entities that perform similar tasks. Response : As we stated in the CY 2014 PFS propo sed rule (78 FR 43362), we proposed this requirement to ensure that the entit y seeking to become a qualified clinical data registry is sufficient in size and technical capability. Because we believe that a qualified clinical data registry should be more robust in technical capabilities than a traditional PQRS -qualified registry, we be lieve that a qualified clinical data registry should be sufficiently larger in size than a traditional PQRS-qualified registry, which is required to have at least 25 registry particip ants (77 FR 69179). Nonetheless, we understand the commenters’ concerns. Although we do not believe we should drop the minimum threshold to 25, we believe it is reasonable to drop this proposed particip ation threshold to 50 partic ipants. We believe that doubling the number of participants would ensure that the entities seeking to become qualified as a qualified clinical data registry would achieve our goal of attracting entities that are more robust in technical capabilities. In addition, we believe that th e other requirements we are finalizing – such as the requirement that an entity seeking to become a qua lified clinical data registry possess benchmarking

### CMS-1600-FC 769

capabilities – will help to ensure that an entity seeking to become a qualifie d clinical data registry is well established. Therefore, for an entity to become qualif ied for a given year, we are adopting the requirement that the entity must have at least 50 clinical data regi stry participants by January 1 the year prior to the year for which the entity seeks to submit clinical qua lity measures data (for example, January 1, 2013, to be eligible to participate under the program with regard to data collected in 2014). Please note that not all participants would be required to participate in PQRS.

Comment : One commenter requested that we only re quire that an entity seeking to become a qualified clinical data registry have at least 100 clinical data registry participants by January 1 the year in which the entity seeks to submit clinical quality meas ures data (for example, January 1, 2014, to be eligible to participate under the program with regard to data collected in 2014) rather than the year prior to which the entity seeks to submit clinical quality measures data, because the commenter believes that this sufficiently ensures the leg itimacy of an entity while providing entities with more time to gain participants. Response : We appreciate the commenter’s feedback. However, as we are requiring that a entity be in existence as of the year prior to which the entity seeks to participate in the PQRS as a qualified clinical data registry, we believe it is important that an entity have at least 50 participants the year prior to which the entity seeks to submit clinical quality meas ures data (for example, January 1, 2013 to be eligible to participate under the program with regard to data collected in 2014) to ensure that the entity is adequately established to participate in the PQRS as a qua lified clinical data registry prior to the start of the reporting periods occurring in 2014.

● Not be owned or managed by an individua l, locally-owned, single-specialty group (for example, single-specialty practices with only 1 prac tice location or solo practitioner practices would be precluded from becoming a qualified clinical data regi stry) (78 FR 43362). We solicited and received the following public comment on th is proposed requirement:

Comment : Some commenters supported this proposal , as it encouraged shared care across specialties and groups. However, one commenter opposed this proposal, as the commenter does not

### CMS-1600-FC 770

believe that a registry that covers patients within on ly a single group, even if multi-specialty or covering multiple states or regions, should meet the definition of a registry. Response : We appreciate the commenter’s support and, based on the commenters’ support, are finalizing this requirement, as proposed. In addition, for transparency purposes, we propo sed (78 FR 43362) that a qualified clinical data registry must:

● Enter into and maintain with its participa ting professionals an appropriate Business Associate agreement that provides for the qualified clinical data registry’s receipt of patient-specific data from the eligible professionals, as well as the qualified clinical data registry’s public disclosure of quality measure results. We solicited and received the following public comment on this pr oposed requirement:

Comment : One commenter expressed concern with this proposed requirement, as the commenter believes that many registries will have to modify their business agreements to account for public disclosure of quality measure results. Response : We understand the commenter’s concerns on proposing to require that an entity’s business agreement account for public disclosure of qua lity measure results. However, we believe that our desire for transparency in reporting outweighs the commenter’s concerns. Therefore, we are finalizing this requirement, as proposed.

● Describe to CMS the cost for eligible professi onals that the qualified c linical data registry charges to submit data to CMS (78 FR 43362). We solicited and received the following public comment on this proposed requirement: Comment: One commenter supported this proposal. Response: We appreciate the commenter’s positive feedback and are finalizing this requirement, as proposed. We also proposed (78 FR 43362) to require qualifie d clinical data registries to meet the following requirements pertaining to the transmission of quality measures data to CMS:

### CMS-1600-FC 771

● To ensure that the qualified clinical data re gistry is compliant with applicable privacy and security laws and regulations, the entity must describe its plan to maintain Data Privacy and Security for data transmission, storage and reporting (78 FR 43362).

Comment : One commenter supported this proposal. Some commenters requested clarification as to how to successfully comply with certain security and privacy laws, as CMS has not provided specific guidance on how to maintain compliance with these laws. Response : We understand the commenters’ concerns re garding security and privacy laws related to the transmission of patient data. As addressing ho w to comply with applicable privacy and security laws and regulations is outside the sc ope of this final rule , we are simply finalizing a requirement that an entity seeking to be a qualified clini cal data registry comply with these laws. Therefore, we are not providing additional guidance on this proposed requi rement. However, we would expect that in developing a plan to maintain data privacy and secu rity for data transmission, storage, and reporting, qualified clinical data registries would assess the laws and regulations governin g such requirements and incorporate appropriate safeguards into their plans. We are finalizing these requirements, as proposed.

● Comply with a CMS-specified secure method for quality data submission (78 FR 43362). We solicited and received the following public co mment on this proposed requirement:

Comment : One commenter supported this proposal. Response : We appreciate the commenter’s positive fee dback and are finalizing this requirement, as proposed.

● Provide information on each measure to be re ported by an eligible professional, including a summary of supporting evidence/rationale, title, numer ator, denominator, exclusions/exceptions, data

elements and value sets in addition to measure le vel reporting rates, patient-level demographic data

and/or the data elements needed to calculate the reporting rates by TIN/NPI (78 FR 43362). We solicited and received the following public comme nt on this proposed requirement:

Comment : While one commenter supported the collecti on of aggregate quality measures data, the commenter opposed providing to CMS specific informa tion that this proposed requirement suggests as it

### CMS-1600-FC 772

is akin to requiring the reporting of patient-level data. The commenter requests clarification on this proposed requirement. Response : Please note that this proposed requirement does not require reporting of patient-level data. Rather, this proposed requirement requires ta qua lified clinical data registry to provide the measure specifications on each measure to be reported by an el igible professional. For more information on what level of specificity is needed, please refer to the 2013 PQRS Measures List available at http://www.cms.gov/Medicare/Quality -Initiatives-Patient-AssessmentInstruments/PQRS/MeasuresCodes.html . For the reasons we explained, and since we received no direct opposition to this proposal, are fina lizing this requirement, as proposed.

● Submit an acceptable “validation strategy” to CMS by March 31 of the reporting year the entity seeks qualification (for example, if an entity wishes to become qualified for participation with regard to data collected in 2014, this validation st rategy would be required to be submitted to CMS by March 31, 2014). A validation strategy would deta il how the qualified clinical data registry will determine whether eligible professionals succeed in reporting clinical quality measures. Acceptable validation strategies often include such provisions as the entity being able to conduct random sampling of their participant’s data, but may also be based on othe r credible means of verifying the accuracy of data content and completeness of reporting or adherence to a required sampling method (78 FR 43362). For a template for data validation and in tegrity, please also see the requirements for certification of an EHR product by the Office of the National Coordinator fo r Health Information Technology (ONC) that are explained at http://www.healthit.gov/policy-researchers-implementers/2014-edition-final-test-method

. Comment : Some commenters supported this proposed requirement. Other commenters requested clarification on the definition of an acceptable “validation strategy.” Response : Please note that, to maintain flexibility, we did not identify a specific validation strategy. Rather, we outlined what such a validati on strategy would need to demonstrate – namely, to determine whether eligible professionals succeed in reporting clinical quality measures. Should entities wishing to become qualified clinical data registries for 2014 require additional guidance and to vet their

### CMS-1600-FC 773

strategies, CMS will provide guidance in subregulatory communication. Therefore, we are finalizing this proposal, as proposed.

● Perform the validation outlined in the strate gy and send evidence of successful results to CMS by June 30 of the year following the reporting period (for example, June 30, 2015, for data collected in the reporting periods occurring in 2014) (78 FR 43363 ). We solicited and recei ved the following public comment on this proposed requirement:

Comment : One commenter supported this proposed requirement. Response : We appreciate the commenter’s positive fee dback and are finalizing this requirement, as proposed.

● Obtain and keep on file for at least 7 year s signed documentation that each holder of an NPI whose data are submitted to the qualified clinical da ta registry has authorized the registry to submit quality measure results and numerator and denominator data and/or patient-specific data on beneficiaries to CMS for the purpose of PQRS participation. This documentation would be required to be obtained at the time the eligible professional signs up with th e qualified clinical data registry to submit quality measures data to the qualified clinical data registry and would be required to meet any applicable laws, regulations, and contractual business associate agreements (78 FR 4 3363). We solicited and received the following public comment on this proposal:

Comment : One commenter supported this proposed requirement. Response : We appreciate the commenter’s positive f eedback and are finalizing this requirement, as proposed.

● Upon request and for oversight purposes, provi de CMS access to the qualified clinical data registry’s database to review the beneficiary data on which the qualified clinical data registry-based submissions are based or provide to CMS a copy of the actual data (78 FR 43363). We solicited and received the following public co mment on this proposal:

Comment : Several commenters opposed this proposed requirement, as the commenters fear that this would violate patient privacy laws. One of th e commenters believes that both eligible professionals

### CMS-1600-FC 774

and their patients would be oppo sed to this proposed requirement, as it provides CMS access to patientlevel data. Response : CMS shares the commenters’ interest in ensuring the protection of individually

identifiable health information. As a HIPAA Cove red Entity, the Medicare program fully intends to limit its data demands to the minimum data necessary to ach ieve a statistically valid audit of the registry’s

submissions. We believe that such disclosures are well within the Privacy Rule’s provisions governing “oversight” disclosures. For the reasons stated previously, we are finalizing this requirement, as proposed.

● Prior to CMS posting the list of qualified clinical data registries for a particular year, verify the information contained on the list (includes names, cont act information, measures, cost, etc.) and agree to furnish/support all of the services listed on the lis t (78 FR 43363). We solicited and received the following public comment on this proposal:

Comment : One commenter supported this proposed requirement. Response : We appreciate the commenter’s positive fee dback and are finalizing this requirement, as proposed.

● Make available to CMS samples of patient level data to audit the entity for purposes of validating the data submitted to CMS by the qualified c linical data registry, if determined to be necessary (78 FR 43363). We proposed this requirement to be able to conduct audits on clinical data registries for oversight purposes.

Comment : Several commenters opposed this proposed requirement, as the commenters fear that this would violate patient privacy laws. One comme nter opposed this proposed requirement as it is duplicative of the proposed requirement to submit a validation strategy to CMS. Response : CMS is tasked with overseeing the approp riate dispersal of funds from the Medicare trust fund, including the funds issued as PQRS paym ent incentives or adjustment s made to fee schedule payments, as a result of PQRS reporting via qualified clin ical data registries. This oversight is achieved through auditing the records CMS receives that serve as the basis for an amount paid out of the trust

### CMS-1600-FC 775

fund. CMS intends to exercise its oversight authorit y in full conformance with the HIPAA Privacy Rule’s provisions governing an oversight authority’s access to the data to carry out th eir oversight functions. With respect to the commenter who believes that this proposed requirement is unnecessary as it is duplicative of the proposed requirement to submit a va lidation strategy to CMS, we disagree. We are finalizing the requirement to submit a validation strate gy to CMS so that CMS can determine whether the validation strategy used is sufficient to help ensure that accurate data is submitted to CMS. Although we proposed both requirements for oversight purposes, the requirement to make available to CMS samples of patient level data to audit the entity for purposes of validating the data submitted to CMS by the qualified clinical data registry, if determined to be necessary, would require more specific data to be made available to CMS. We note that, in all cases, we are requiri ng entities wishing to become qualified clinical data regsitries to submit its validation strategy to CMS, whereas we would only require that data be made available under this requirement only “if necessary.” For the reasons stated previously, we are finalizing this requirement, as proposed.

● The entity must provide information on how th e entity collects quality measurement data, if requested (78 FR 43363). We solicited and received the following public comment on this proposal:

Comment : One commenter supported this proposed requirement. Response : We appreciate the commenter’s positive fee dback and are finalizing this requirement, as proposed.

● By March 31 of the year in which the entity seek s to participate in PQRS as a qualified clinical data registry, the entity must publically post (on the en tity’s website or other publication available to the public) a detailed description (rationale, numerator, denom inator, exclusions/excepti ons, data elements) of the quality measures it collects to ensu re transparency of information to the public (78 FR 43363). We solicited and received the following public comment on this proposed requirement:

Comment : One commenter opposed the proposed Marc h 31 deadline for an entity seeking to participate in the PQRS as a qualified clinical data registry to publically post a detailed description (rationale, numerator, denominator , exclusions/exceptions, data elements) of the quality measures it

### CMS-1600-FC 776

collects to ensure transparency of information to the public. The co mmenter requested that this deadline be extended to June 1 of the year in which the en tity seeks to participate in the PQRS as a qualified clinical data registry to allow time for these entities to prepare its measures for submission under this new reporting mechanism. Response : We understand the commenter’s concerns re garding the March 31 deadline. However, it is not technically feasible to accept this informa tion later than the proposed March 31 deadline, as CMS must have time to be able to analyze the measure to determine how the measures data would be captured by CMS. Therefore, we are finalizing this requirement, as proposed.

● The entity must report, on behalf of its indi vidual eligible professional participants, a minimum of 9 measures that cross 3 NQS domains (78 FR 4 3363). We solicited but received no public comment on this proposed requirement, as most comments were mo re specifically directed to our proposed criteria for satisfactory participation in a qualified clinical data registry for the 2014 PQRS incentive and 2016 PQRS payment adjustment, which we address below. However, since, as we specify below, we are not allowing a qualified clinical data registry to report less than 9 measures covering 3 NQS domains if less than 9 measures are applicable to its eligible professi onal participants, we are modifying this requirement in the following manner: the entity must report, on behalf of its indivi dual eligible professional participants, a minimum of 9 measures that cross 3 NQS domains.

● The entity, on behalf of its i ndividual eligible professional partic ipants, must report on at least one outcomes-based measure (defined in this secti on below). (78 FR 43363)We solicited and received the following public comment on this proposed require ment (please note that most comments related to this proposed requirement were more specifically directed to our proposed criteria for satisfactory participation in a qualified clinical data regist ry for the 2014 PQRS incentive and 2016 PQRS payment adjustment):

Comment : One commenter supported this proposal as it furthers our focus on quality improvement. Other commenters requested clarificatio n as to the definition of an outcome measure and

### CMS-1600-FC 777

requested that certain measures be considered out come measures for purposes of reporting these measures for the PQRS via a qualified clinical data registry. Response : We appreciate the commenter’s feedback and are finalizing this requirement, as proposed. Please note that we further clarify the defi nition of an outcome measure in the section below that describes the final parameters surrounding the me asures for which a qualified clinical data registry may report for purposes of the PQRS.

● The entity, on behalf of its individual eligible professional participants, must report on a set of measures from one or more of the following cat egories: CG-CAHPS; NQF endorsed measures (information of which is available at http://www.qua lityforum.org/Home.aspx); current PQRS measures; measures used by boards or specialty societies; a nd measures used in regional quality collaboratives (78 FR 43363). We solicited and received the following public comment on this proposed requirement:

Comment : One commenter supported this proposal as it furthers our focus on quality improvement. Response : We appreciate the commenter’s feedback and are finalizing this requirement, as proposed.

● The entity must demonstrate that it has a plan to publicly report its quality data through a mechanism where the public and registry participan ts can view data about individual eligible professionals, as well as view regional and national be nchmarks. As an alternative, we considered requiring that the entity must benchmark within its own registry for purposes of determining relative quality performance where appropriate (78 FR 43363).

We solicited and received the followi ng public comments on this proposal:

Comment : Several commenters opposed this propo sed requirement, claiming that publicly reporting measures would be very costly to an entity. The commenters also stated that, if the entity did not already have an existing plan to publicly repo rt measures, it would take entities a significant amount of time (over a year) to establish a plan to publicly report its measures.

### CMS-1600-FC 778

Response : We understand the commenters’ concerns re garding the cost, time, and other expenses associated with publicly reporting quality measures da ta. Please note that CMS only proposed that an entity demonstrate that a plan be developed, but did not explicitly propose that an entity wishing to become a qualified clinical data registry publicly re port measures in 2014. Rather, as a first step, CMS was merely proposing that the entity have a plan in place to eventually publicly report their quality measures data. Regardless, due to the commenters’ c oncerns, we are not finalizing this proposal at this time. We note, however, that CMS encourages these qua lified clinical data registries to move towards the public reporting of quality measures da ta. We plan to establish such a requirement in the future and willrevisit this proposed requirement as part of CY 2015 rulemaking.

● The entity must demonstrate that it has a plan to risk adjust the quality measures data for which it collects and intends to transmit to CMS, where appr opriate. Risk adjustment has been described as a corrective tool used to level the playing field rega rding the reporting of patient outcomes, adjusting for the differences in risk among specific patient s (http://www.sts.org/patient-information/what-riskadjustment). Risk adjustment also makes it possible to compare performance fairly. For example, if an 86 year old female with diabetes undergoes bypass surg ery, there is less chance for a good outcome when compared with a relatively healthier 40 year old male undergoing the same procedure. To take factors into account which influence outcomes, for example, adva nced age, emergency operation, previous heart surgery, a risk adjustment model is used to report surgery results (78 FR 43363).

Comment : Several commenters supported this propo sal as the commenters believe that risk adjustment is a critical component to ensure that th e quality measures data subm itted to CMS provides an accurate picture of the quality of care the eligible professional provides to its patients. Several other commenters, however, opposed the proposed requirement that the entity be required to demonstrate that it has a plan to risk adjust. While th e commenters recognize that risk adjustment is a critical component of quality measurement, the commenters do not believe it s hould be a requirement for qualified clinical data registries currently since it is a resource intensive t ask and one for which there is no single proven model to ensure accuracy.

### CMS-1600-FC 779

Response : We understand the costs associated with risk adjustment. However, we note that several comments responding to the Request for Information titled “Medicare Program; Request for Information on the Use of Clinical Quality Measures (CQMs) Reported Under the Physician Quality Reporting System (PQRS), the Electronic Health Record (E HR) Incentive Program, and Other Reporting Programs” (at 78 FR 9057) stressed the need to risk adjust quality measures data, and we agree. We believe this is especially important as the quality data submitted to CMS by qualified clinical data registries will be used to assess physician performance under the Value-based Payment Modifier. Therefore, for the reasons stated above, we are finalizing this proposal. Please note that we are only requiring that the entity have a plan to risk adjust measures for which risk adjustment may be appropriate. If an entity h as a plan to risk adjust its measures, we strongly encourage that this plan be made available to the pu blic (such as having it posted on the entity’s website). Please note that there are certain measures, such as process measures that only indicate the processes taken when performing a service, for which risk adjustment may not be appropriate. Should CMS find, pursuant to an audit, that a qualified clinical data registry has submitted inaccurate data, CMS also proposed (78 FR 43363) to disqualify the qualified clinical data registry, meaning the entity would not be allowed to submit quality measures data on be half of its eligible professionals for purposes of meeting the criteria for sa tisfactory participation for the following year. Should an entity be disqualified, we proposed that the entity must again become a qualified clinical data registry before it may submit quality measures data on behalf of its eligible professionals for purposes of the individual eligible professional pa rticipants meeting the criteria for satisfactory participation under the PQRS. Additionally, we proposed that the inaccurate data collected would be discounted for purposes of an individual eligible professional meeting the criteria for satisfactory participation in a qualified clinical data registry. We sought and received the following public comments on these proposals.

Comment : Some commenters opposed our proposal not to allow a qualified clinical data registry to re-submit quality measures data on behalf of its eligible professiona ls if CMS discovers the qualified

### CMS-1600-FC 780

clinical data registry has submitted inaccurate da ta. The commenters believe that this proposal unnecessarily and negatively affects eligible professionals’ success in the PQRS. Response: We understand the commenters’ concerns. Ho wever, it is not feasible to accept data later than the last Friday of the February immediat ely following the end of the respective reporting period (that is, February 27, 2015 for reporting periods occurri ng in 2014) and still be able to analyze the data in time to assess whether an eligible professional shoul d be assessed a payment adjustment. Therefore, we are finalizing our proposal not to allow a qualified clin ical data registry to re -submit quality measures data on behalf of its eligible professionals if CMS discove rs the qualified clinical data registry has submitted inaccurate data, as proposed. We note that this limita tion is consistent with other rules for reporting quality measures data via a qualified registry, a direct EHR product, or the EHR data submission vendor. In summary, we are finalizing our proposals related to disqualification of a qualified clinical data registry, as proposed. As we noted, section 1848(m)(3)(E)(i) of the Act, as added by section 601(b) of the ATRA, requires us to establish requirements for an entity to be considered a qualified clinical data registry, including that the entity provide us with such inform ation, at such times, and in such manner, as we determine necessary to carry out the provision. Give n the broad discretion afforded under the statute, we proposed that qualified clinical data registries pr ovide CMS with the quality measures data it collects from its eligible professional participants . We believe it is important that a qualified clinical data registry provide such data for a number of reasons. As we discuss in greater detail below, we believe such information is necessary for purposes of determini ng whether individual elig ible professionals have satisfactorily participated in a clinical qualified data registry under the PQRS. In addition, we proposed (78 FR 43485) to use the quality measures data re ported under the PQRS to assess eligible professionals with regard to applying the value-based payment modifier in an upward, downward, and neutral adjustment to an eligible professional’s Medicare Part B PFS charges. Therefore, we proposed to require that qualified clinical data registries submit qua lity measures data to CMS (78 FR 63363-43364). Specifically, to further ensure that the quality measures data elements are reported to CMS in a

### CMS-1600-FC 781

standardized manner, we proposed to require that qualifie d clinical data registries be able to collect all needed data elements and transmit the data on qua lity measures to CMS, upon request, in one of two formats, either via a CMS-approved XML format or via the Quality Reporting Document Architecture (QRDA) category III format. The CMS-approved XM L format is consistent with how traditional qualified registries under the PQRS transmit data on quality measures to CMS. Although our preference

would be to receive data on quality measures via the QRDA category III format only, since the QRDA category III format is one of the formats we require for an EP’s EHR or an EHR data submission vendor to submit quality measures data (see 77 FR 69183), we noted that we understood that the quality measures data collected by qualified clinical data regi stries vary and that these qualified clinical data registries may not be equipped to submit quality measures data to CMS using the QRDA category III format. We stated that in future years, it was our in tention to require all qualified clinical data registries to provide quality measures data via the QRDA category III format. We solicited and received the following pub lic comments on our proposal to accept quality measures data from a qualified clinical data registry in one of two formats, either via a CMS-approved XML format or via the QRDA category III format:

Comment : Several commenters supported our proposal to accept quality measures data in a CMSapproved XML format. Some commenters suggested clar ification as to whether an qualified clinical data registry would have to be able to separate th e reporting of Medicare vs. non-Medicare patients when submitting quality measures data to CMS. Response : We appreciate the commenters’ support, and based on the comments received and for the reasons stated above, are finalizing our prop osal to accept quality measures data from a qualified clinical data registry in a CMS-approved XML format. Please note that CMS will not require the qualified clinical data registry submitting quality measures data on an eligible professional’s behalf to separate the reporting of measures on the eligible professional’s Medicare vs. non-Medicare patients.

Comment : Several commenters supported our proposal to accept quality measures data via the QRDA category III format, as this aligns with th e format accepted under the EHR Incentive Program.

### CMS-1600-FC 782

Response : We appreciate the commenters’ feedback. However, after exploring the technological capabilities of our analysis systems, we have discovere d that it is not technically feasible to accept quality measures data via a QRDA III format other than th e electronically specified clinical quality measures (eCQMs) that may be reported to meet the CQM co mponent of meaningful use under the EHR Incentive Program in 2014. In the future, we hope to further deve lop our analysis systems so that we are capable of accepting quality measures data via the QRDA category III format for additional measures. Therefore, for the reasons stated previously and based on the comments received, we are finalizing our proposal to accept quality measures data via the QRDA category III format exclusively for the 64 eCQMs that may be reported to meet the CQM component of mean ingful use under the EHR Incentive Program in 2014 that are also reportable under the PQRS in 2014. We are finalizing the option to submit quality measures data via the QRDA category III format exclusively fo r the 64 eCQMs that may be reported to meet the CQM component of meaningful use under the EH R Incentive Program in 2014 because, unlike potential non-PQRS measures that may be reported by eligible pr ofessionals in a qualified clinical data registry, we are already able to analyze the measures specifications for these measures. Since we do not currently have the measures specifications for the non-PQRS measures that will be submitted via a qualified clinical data registry, it is not feasible to test these measures to determine wh ether we are able to accept these measures data in a QRDA category III format. To ensure that the data provided by the qualified clinical data registry is correct, we proposed to require that qualified clinical data registries pr ovide CMS a signed, written attestation statement via e-mail which states that the quality measure results and any and all data including numerator and denominator data provided to CMS are accurate and complete (78 FR 43364). We solicited and received the following public comment on this proposal:

Comment : One commenter supported this proposed requirement. Response : We appreciate the commenter’s feedback a nd, based on the comments received and for the reasons stated above, are therefore finalizing this requirement, as proposed.

### CMS-1600-FC 783

We proposed (78 FR 43364) that, regardless of wh ether the eligible professional uses the XML or QRDA III format to report quality measures data to CMS, the qualified clinical data registry would be required to submit this data no later than the last Fr iday occurring 2 months after the end of the respective reporting period (that is, February 27, 2015 for report ing periods occurring in 2014). We also proposed that, if a qualified clinical data registry is submitti ng quality measures data on beha lf of individual eligible professionals that are part of the same group practi ce (but not participating in the PQRS GPRO), the qualified clinical data registry would have the optio n to report the quality measures data to CMS in a batch containing data for each of the individual elig ible professionals within the group practice, rather than submitting individual files for each eligible pr ofessional (78 FR 43364). We solicited and received the following public comment on this proposal:

Comment : Some commenters requested that qualified clin ical data registries be given more time to submit quality measures data to CMS, particularly since the qualified clinical data registry reporting

mechanism is new. Some of these commenters re quested that we extend the deadline to March 31 following the end of the respective reporting period (that is, March 31, 2015 for reporting periods occurring in 2014), at least for the first year in which a qualified clinical data registry must submit quality

measures data to CMS. Response : We appreciate the commenters’ concerns. However, it is not technically feasible to accept quality measures data from qualified clinical data registries any later than the last Friday occurring 2 months after the end of the respective reporting peri od (that is, February 27, 2015 for reporting periods occurring in 2014). The additional time is needed to complete a thorough analysis of the submitted data prior to the application of the 2016 PQRS payment adju stment. Therefore, we are finalizing our proposal that a qualified clinical data registry would be require d to submit this data no later than the last Friday occurring 2 months after the end of the respective reporting period (that is, February 27, 2015 for reporting periods occurring in 2014), as proposed. In conjunction with our proposal to require that quali fied clinical data registries be able to provide data on quality measures in a CMS-approved XML format , we proposed to require that qualified clinical

### CMS-1600-FC 784

data registries report back to participants on the co mpleteness, integrity, and accuracy of its participants’ data (78 FR 43364). We believe that it would be beneficial to the participants to receive feedback on the data transmission process so that the participants ar e aware of any inaccuracies transmitted to CMS. We solicited and but received no public comment on this proposal. Therefore, we are finalizing this requirement, as proposed. Alternatively, for the information CMS would require a qualified clinical data registry to furnish to CMS to determine that the eligible professionals ha ve met the criteria for satisfactory participation for the 2014 PQRS incentive and 2016 PQRS payment adju stment, in lieu of accepting quality measures data for reporting periods occurring in 2014 only, we cons idered proposing (78 FR 43364) that a qualified clinical data registry provide CMS with a list of the eligible professionals (containing the respective eligible professionals’ TIN/NPI information) who par ticipated in and reported quality data to the qualified clinical data registry to determine which individual eligible professionals met the criteria for satisfactory participation for the 2014 PQRS incentive and 2016 PQRS payment adjustment. We considered this alternative because we do not have experience collecti ng data from qualified clinical data registries, we are unfamiliar with the type of quality data qualified clinical data registries collect, and we are still building out our data infrastructur e. We solicited and received the following public

comment on this alternative:

Comment : Several commenters preferred requiring a qua lified clinical data registry provide CMS with a list of the eligible professionals (containi ng the respective eligible professionals’ TIN/NPI information) who participated in and reported quality data to the qualified clin ical data registry to determine which individual eligible professionals met the criteria for satisfactory participation for the 2014 PQRS incentive and 2016 PQRS payment adjust ment in lieu of submitting actual quality measures

data. Some of the commenters were concerned that a qualified clinical data registry seeking to participate in the PQRS would not be able to submit actual quality measures data to CMS in 2014, as the entities would not have enough time to adjust its systems to submit quality measures data in this initial year.

### CMS-1600-FC 785

Response : We appreciate the commenters’ feedback a nd understand the tight timeline that must be adhered to for a qualified clini cal data registry to submit quality measures data to CMS for the 12- month reporting period occurring in 2014 for the 2014 PQRS incentive and 2016 PQRS payment adjustment. However, as for the reasons we noted abov e, we believe it is important to collect such data under the PQRS. Additionally, we note that for the Va lue-based Payment Modifier, which is based off of data submitted via the PQRS,to be able to accurately compare performance in the PQRS across eligible professionals, it is necessary to receive actual quality me asures data from qualified clinical data registries. Therefore, we are not adopting this alternative. Please note that we will post additional guidance a nd information on the requirements to become a qualified clinical data registry, as well as information on how a qualified clinical data registry will submit quality measures data for reporting periods occurring in 2014 on the PQRS website at http://www.cms.gov/Medicare/Quality-Initiatives-Pa tient-Assessment-Instruments/PQRS/index.html

. c. Process for Being Designated as a Qualified Clinical Data Registry Section 1848(m)(3)(E)(v) of the Act, as added by section 601(b) of the ATRA, requires the Secretary to establish a process to determine whether or not an entity meets the requirements established under section 1848(m)(3)(E)(i) of the Act. Such proc ess may involve one or both of the following: (I) A determination by the Secretary; (II) A designation by the Secretary of one or more independent organizations to make such determination. This section sets forth our proposals for our process to determine whether or not an entity should be d esignated as a qualified clinical data registry. Consistent with what we require of traditi onal qualified registries under the PQRS, we proposed that an entity must submit a self-nomination statement th at indicates its intent to participate in PQRS as a qualified clinical data registry (78 FR 43364). We believe this self-nomination statement is necessary for CMS to anticipate how many clinical data regist ries would participate for a certain year, as well as provide information to eligible prof essionals about potential participati ng clinical data registries. We proposed that the self-nomination statement contain the following information:

● The name of the entity seeking to become a qualified clinical data registry.

### CMS-1600-FC 786

● The entity’s contact information, includi ng phone number, email, and mailing address.

● A point of contact, including the contact’s email address and phone number, to notify the entity of the status of its request to be co nsidered a qualified clinical data registry.

● The measure title, description, and specificati ons for each measure the qualified clinical data registry would require its eligible professionals to report for purposes of participating in PQRS. In addition, the qualified clinical data registry must describe the rationale and ev idence basis to support each measure it would require its eligible professionals to report.

● The reporting period start date the entity will cover as a clinical data registry. Since we believe that accepting these statements vi a email would be the most efficient method for collecting and processing self-nomination statements, we proposed to accept self-nomination statements via email only (78 FR 43364). However, in the event th at it is not technically feasible to collect this selfnomination statement via email, we proposed that entities seeking to become qualified clinical data registries submit its self-nomination statement via a mailed letter to CMS. The self-nomination statement would be mailed to the following address: Centers fo r Medicare & Medicaid Services, Center for Clinical Standards and Quality, Quality Measurement and He alth Assessment Group, 7500 Security Boulevard, Mail Stop S3-02-01, Baltimore, MD 21244-1850. To ensure that CMS is able to process these sel f-nomination statements as early as possible, we proposed (78 FR 43364) that these self-nomination st atements must be received by CMS by 5:00 p.m. Eastern Standard Time (e.s.t.) on January 31 of the y ear in which the clinical data registry seeks to be qualified (that is, January 31, 2014 for purposes of b ecoming a qualified clinical data registry for the reporting periods for the 2014 PQRS incentive and 2016 PQRS payment adjustment). We indicated that we anticipated posting a list of the entities that are designated by CMS as qualified clinical data registries in fall of the same year (78 FR 43365). Since participation in a qualified clinical data registry is a new option for individual eligible professionals, we stated that we anticipated making changes to the requirements for becoming a qualified clinical data registry in future rulemaking as we gain more experience with this option. Since we believe

### CMS-1600-FC 787

it is important that the entity keep up with these chang es, at this time, we proposed that entities seeking to serve as qualified clinical data registries must sel f-nominate for each year that the entity seeks to participate (78 FR 43365). In the future, we noted we anticipated moving towards a multi-year selfnomination process as the requirements for qualified clinical data registries become firmly established; however, at this time, we proposed self-nomination for an y year in which a qualified clinical data registry intends to participate under the PQRS. We solicited and received the following public comment on these proposals:

Comment : Some commenters opposed our proposed deadline to receive self-nomination statements by January 31 of the year in which the c linical data registry seeks to be qualified. These commenters believed that this proposed deadline di d not provide entities with enough time to decide whether they should seek to become a qualified clini cal data registry, particularly since the final requirements for an entity to become a qualified clini cal data registry would not be made available until the CY 2014 PFS final rule with comment period is displayed (approximately November 2013). Response : We understand the commenters’ concerns. Ho wever, as it is the first year in which this reporting mechanism will be implemented, it is not feasible to accept self-nomination statements later than Jaunary 31 of the year in wh ich an entity seeks to become a qualified clinical data registry. CMS needs sufficient time to allow system updates to accomm odate entties seeking to be qualified clinical data registries as well as work with entities who are seeking to become qualified clinical data registries. Therefore, we are finalizing our proposed deadline to receive self-nomination statements from entities wishing to become qualified clinical data registry by 5:00 p.m. (e.s.t.) on January 31 of the year in which the clinical data registry seeks to be qualified (that is, January 31, 2014 for purposes of becoming a qualified clinical data registry for the reporti ng periods for the 2014 PQRS incentive and 2016 PQRS payment adjustment), as proposed.

Comment : Some commenters generally supported the proposed self-nomination process for entities wishing to become qualified as a qualified clinical data registry.

### CMS-1600-FC 788

Response : We appreciate the commenters’ response and, for the reasons stated above and based on the comments received, are finalizing this proposed process for being designated as a qualified clinical data registry, as proposed. d. Reporting Period for the Satisfact ory Participation by Individual E ligible Professionals in a Qualified Clinical Data Registry for the 2014 PQRS Incentive Section 1848(m)(3)(D) of the Act, as redesigna ted and added by section 601(b) of the ATRA, authorizes the Secretary to treat an individual e ligible professional as satisfactorily submitting data on quality measures under section 1848(m)(A) of the Act if the eligible professional is satisfactorily participating in a qualified clinical data registry for th e year. Given that satisfactory participation is with regard to the year, and to provide consistency with the reporting period applicable to individual eligible professionals who report quality measures data unde r section 1848(m)(3)(A), we proposed to modify §414.90(c)(5) to specify a 12-month, calendar year (CY) reporting period from January 1, 2014 through December 31, 2014 for individual eligible professionals to satisfactorily participate in a qualified clinical data registry for purposes of the 2014 PQRS incentiv e (78 FR 43365). We invited and received the following public comment on the proposed 12-mont h, CY 2014 reporting period for the satisfactory participation of individual eligible professionals in a qualified clinical data registry for the 2014 PQRS

incentive:

Comment : Some commenters provided general suggesti ons to align reporting periods for various CMS quality reporting programs wherever possible. Response : We agree with the commenters. In fact, the proposed 12-month, CY 2014 reporting period for the satisfactory participation of individual eligible professionals in a qualified clinical data registry for the 2014 PQRS incentive aligns with th e 12-month CY 2014 reporting period for meeting the criteria for satisfactory reporting for the 2014 PQRS incentive. Therefore, we are adding paragraph §414.90(i)(1) to specify a 12-month, CY 2014 reporti ng period for the satisfactory participation of individual eligible professionals in a qualified clini cal data registry for the 2014 PQRS incentive, as proposed.

### CMS-1600-FC 789

e. Criteria for Satisfactory Participation for Individua l Eligible Professionals In a Qualified Clinical Data Registry for the 2014 PQRS Incentive For 2014, in accordance with §414. 90(c)(3), eligible professionals that satisfactorily report data on PQRS quality measures are eligible to receive an in centive equal to 0.5 percent of the total estimated Medicare Part B allowed charges for all covered professional services furnished by the eligible professional or group practice during the applicable re porting period. Section 1848(m)(3)(D) of the Act, as redesignated and added by section 601(b) of the AT RA, authorizes the Secretary to treat an individual eligible professional as satisfactorily submitting da ta on quality measures under section 1848(m)(A) of the Act if, in lieu of reporting measures under section 1848(k)(2)(C) of the Act, the eligible professional is satisfactorily participating in a qu alified clinical data registry for th e year. “Satisfactory participation” is a new standard under the PQRS and is a substitu te for the underlying standard of “satisfactory reporting” data on covered professional services that el igible professionals must meet to earn a PQRS incentive or avoid the PQRS payment adjustment. Therefore, we proposed to modify §414.90 to add paragraph (c)(5) to indicate that indi vidual eligible professionals shall be treated as satisfactorily reporting data on quality measures if individual eligible professionals satisfactorily participate in a qualified clinical data registry for purposes of the PQRS incentive (78 FR 43365). We solicite d but received no public comment on this proposal. Therefore, we are finaliz ing our proposal to modify §414.90 to add paragraph (c)(5) to indicate that individual eligible professionals shall be treated as satisfa ctorily reporting data on quality measures if individual eligible professionals sa tisfactorily participate in a qualified clinical data registry for purposes of the PQRS incentive, as proposed. In addition, to establish a standard for satisf actory participation in a qualified clinical data registry , we proposed that, to meet the criteria for satisfactory participation for the 2014 PQRS incentive, an individual eligible professional would be require d to: For the 12-month 2014 reporting period, report at least 9 measures available for reporting under the qua lified clinical data registry covering at least 3 of the NQS domains, OR, if less than 9 measures apply to the eligible professional, report 1—8 measures, AND report each measure for at least 50 percent of the eligible professional’s applicable patients. Of the

### CMS-1600-FC 790

measures reported via a qualified clinical data regist ry, the eligible professional must report on at least 1 outcome measure (78 FR 43365). We solicited a nd received the following public comment for these proposals:

Comment : Several commenters opposed our proposal to require that, of the measures reported via a qualified clinical data registry, the eligible pr ofessional must report on at least 1 outcome measure. Some of these commenters noted that, there are many specialties for which outcomes measures may not yet be available, hindering these specialties from partic ipating in the PQRS via a qualified clinical data registry. Response : We understand that certain specialties may not have outcome measures for which they may report. However, we believe it is important to emphasize the reporting of outcomes measures, as we believe they provide better metrics in the quality of care an eligible professional provides than process measures do. To encourage the reporting of outcome measures, we are therefore finalizing our proposal to require that, of the measures reported via a qualified clinical data registry to meet the criteria for satisfactory participation in a qualified clinical data registry for the 2014 PQRS incentive, the eligible professional must report on at least 1 outcome measure.

Comment : Several commenters supported our proposal to require that an eligible professional report each measure for at least 50 percent of the eligible professional’s applicable patients. The commenters supported our proposal specifically because it aligns with the opti on to report individual

measures via the claims-based re porting mechanism. One commenter, however, opposed this proposal. Instead, the commenter suggested th at CMS allow a qualified clinical data registry to submit its verifiable, statistically supported sampling met hodology to CMS for review and require eligible professionals to report a sufficient number of cases as determined by the individual registry’s sampling requirements. Response : We appreciate the commenters’ positive f eedback. For the suggestion to allow a qualified clinical data registry to submit qualit y measures data based on an approved sampling methodology created by the clinical data registry, we do not believe this is sufficient for the PQRS at this

### CMS-1600-FC 791

time. Particularly since the quality measures data received through the PQRS will be used to assess eligible professionals under the Value-based Payment M odifier, we believe it is important to receive data consistent with the data we are receiving via th e claims and registry-based reporting mechanisms. Therefore, we are finalizing this proposal. Fo r the 2014 PQRS incentive, an eligible professional reporting individual qua lity measures via a qualified clinical data registry will be required to report each measure for at least 50 percent of the eligible pr ofessional’s applicable patients. Please note, however, that as the program evolves, we anticipate increasing th e reporting threshold for the qualified clinical data registry reporting mechanism.

Comment : While several commenters generally supporte d our proposal to require the reporting of more than 3 measures, the commenters believed that requiring the reporting of at least 9 measures covering at least 3 of the NQS domains is too onerous. These commenters suggested requiring the reporting of either 4 measures covering at least 1 NQS domain, 5 measures covering at least 2 NQS domains, or 6 measures covering at least 2 NQS domains. Response : We appreciate the commenters’ support for our desire to require the reporting of more than 3 measures to meet the criteria for satisfactory pa rticipation in a qualified clinical data registry for the 2014 PQRS incentive. For purposes of the 201 4 PQRS incentive, we believe that requiring the reporting of 9 measures is appropriate for satisfactory participation, as th e proposal is consistent with the requirement for an eligible professional to report on at least 9 individual measures to meet the criteria for satisfactory reporting for the 2014 PQRS incentive. In fact, while we understand the commenters’ concerns that an eligible professional reporting via the claims or traditional registry may not have 9 relevant measures for which to report, we do not belie ve the same argument can be made for an eligible professional reporting quality measures data via a qua lified clinical data reporting. An eligible professional reporting via a qualified clin ical data registry is not limited to reporting on measures within the PQRS measure set. Rather, an eligible professional using the qualified clinical data registry reporting mechanism may report on measures that are outside of the PQRS measure set. Based on the comments received and for the reasons stated previously, we are finalizing our proposal to require an individual

### CMS-1600-FC 792

eligible professional using a qualified clinical data re gistry to report on at least 9 measures for the PQRS

incentive.

Comment : Several commenters generally supported the reporting of measures across multiple NQS domains, as reporting on a variety of measures provi des eligible professionals with a better picture of the full continuum of care provided. Response : We agree with the commenters. Based on the comments received, we are finalizing our proposal to require an individu al eligible professional using a qualifie d clinical data registry to report on at least 9 measures covering at least 3 of the NQS domains for the 2014 PQRS incentive.

Comment : Several commenters supported our proposal to allow an eligible professional to report less than 9 measures, should less than 9 measures be app licable to the eligible professional. Several of the commenters sought clarification on how CMS would determine whether additional measures could be reported by an eligible professional. Response : We appreciate the commenters’ feedback. Unfortunately, at this time, it is not feasible for us to finalize an option to report on less than 9 me asures via a qualified clinical data registry for the 2014 PQRS incentive. In order to do so, we believe we would need to apply the MAV process. Although we are able to implement a MAV process for the claims and registry-based reporting mechanisms to determine whether an eligible professional could have reported on additional measures, we are unable to implement a similar process for the qualified clini cal data registry-based reporting mechanism as the measures that may be reported via a qualified clinical data registry are not required to be measures found in the PQRS measure set. Therefore, it would be difficult for CMS to determine appropriate measure clusters for the MAV process. Until we can implem ent a MAV process where we are able to accurately identify the measure clusters, we do not believe it is a ppropriate to adopt such a change to the criterion. Therefore, eligible professionals must report on at least 9 measures covering at least 3 of the NQS

domains.

Comment : Several commenters urged CMS to allow the reporting of measures groups under the qualified clinical data registry reportin g mechanism for the 2014 PQRS incentive.

### CMS-1600-FC 793

Response : We agree with the commenters. However, please note that we are not restricting this reporting criterion to individual measures. Rather, as we discuss in greater detail in the PQRS measures section below, a qualified clinical data registry is free to choose which measures its participants will report for purposes of the PQRS. Should a qualified clin ical data registry require its eligible professionals to report on a cluster of measures similar to PQ RS measures groups, the measu res within the measures group would count as separate, individual measures.

Based on the comments received and for the reas ons explained previously, as we specify in §414.90(i), we are finalizing the following criteria fo r an individual eligible professional to meet the criteria for satisfactory participation for the 2014 PQRS incentive: For the 12-month 2014 reporting period, report at least 9 measures available for reporti ng under the qualified clinical data registry covering at least 3 of the NQS domains AND report each measure for at least 50 percent of the eligible professional’s applicable patients. Of the measures re ported via a qualified clinical data registry, the eligible professional must report on at least 1 outcome measure. We further proposed that a qualified clinical data registry may submit data on more than 9 quality measures on behalf of an eligible professional (78 FR 43365). However, we proposed that a qualified clinical data registry may not submit data on more th an 20 measures on behalf of an eligible professional. We proposed to place a limit on the number of measures that a qualified clinical data registry may submit on behalf of an eligible professional at this time be cause we have no experience with qualified clinical data registries and the types of da ta on quality measures that they collect. We solicited and but received no public comment on this proposal. Although we have the capacity to accept quality me asures data from all measures finalized in the PQRS measure set specified in Table 52, in anal yzing our capability to accept quality measures data, we

discovered that it would not be feasible for CM S to accept quality measures data on more than 20 measures not specieid in Table 52 from a qualified clinical data registry at this time. CMS needs to have adequate time to analyze the measures provided to determine how the quality measures data will be calculated. We solicied but received no public comme nt on this proposal. Therefore, for the reasons

### CMS-1600-FC 794

stated above, we are capping the number of non-PQ RS measures CMS may receive from each qualified clinical data registry to 20 so as not to be inundate d with measures whose specifications must be analyzed prior to the submission deadline for qualified clinical data registries to submit quality measures data to CMS. Therefore, we are limiting the number of qua lity measures a qualified clinical data registry may submit to no more than 20 measures not specified in Table 52 on behalf of an eligible professional. Qualified clinical data registri es may submit quality measures data on any or all measures specified in Table 52 of this final rule with comment period. As the qualified clinical data registry reporting option develops, we hope to be able to accept data on more quality measures outside of the PQRS measure set in the future. Please note that this restriction also app lies to measures being reported to meet the criteria for satisfactory participation in a qualified clinical da ta registry for the 2016 PQRS payment adjustment. f. Reporting Period for the Satisfactory Participation for Individual Eligible Professionals in a Qualified Clinical Data Registry for the 2016 PQRS Payment Adjustment Section 1848(m)(3)(D) of the Act, as redesigna ted and added by section 601(b) of the ATRA, authorizes the Secretary to treat an individual e ligible professional as satisfactorily submitting data on quality measures under section 1848(m)(A) of the Act if the eligible professional is satisfactorily participating in a qualified clinical data registry for th e year. Given that satisfactory participation is with regard to the year, and to provide consistency with how individual eligible professionals report quality measures data to a qualified clinical data registry, we proposed to modify §414.90(e)(2) to specify a 12- month, calendar year (CY) reporting period from January 1, 2014 through December 31, 2014, for individual eligible professionals to satisfactorily par ticipate in a qualified clinical data registry for purposes of the 2016 PQRS payment adjustment (78 FR 43366). We invited and received the following public comments on the proposed 12-month, CY 2014 reporting period (that is, January 1, 2014 – December 31, 2014) for the satisfactory participation of individual eligible professionals in a qualified clinical data registry for the 2016 PQRS payment adjustment:

### CMS-1600-FC 795

Comment : Several commenters opposed our proposal to base the 2016 PQRS payment adjustment year on a reporting period occurring 2 ye ars prior to the payment adjustment year. The commenters believe that the reporting period should occur closer to the payment adjustment year. Response : We understand the commenters’ concerns on establishing a reporting period 2 years prior to the payment adjustment year. However, it is not operationally feasible to create a full calendar year reporting period for the 2016 PQRS payment adjustment any later than 2 years prior to the adjustment year and still avoid retroactive payments or the reprocessing of claims. Section 1848(a)(8) of the Act requires that a payment adjustment be app lied to covered professional services furnished by an eligible professional in the particular payment adjust ment year. Therefore, we believe it is necessary to reduce the PFS amount concurrently for PFS allowed ch arges for covered professional services furnished

in 2016. If we do not reduce the PFS amount concurren tly with claims submissi ons in 2016, we would need to potentially recoup or provide added payments after the determination is made about whether the payment adjustment applies, or alternatively, hold cl aims until such a determination is made. In addition, we note that if such retroactive adjustments were made it may require a reconciliation of beneficiary copayments. As a result, we need to determine whet her eligible professionals ha ve satisfactorily reported under the PQRS based on a reporting period that occurs prior to 2016. For the reasons stated here and above, we are specifying under §414.90(k)a 12-month, CY 2014 reporting period (that is, January 1, 2014 – December 31, 2014) for the satisfactory participatio n of individual eligible professionals in a qualified clinical data registry for the 2016 PQRS payment adju stment. As we stated in the proposed rule (78 FR 43366), this final reporting period for the 2016 PQRS pa yment adjustment is consistent with the 2016 PQRS payment adjustment reporting peri ods for all other reporting mechanisms. g. Criteria for the Satisfactory Par ticipation for Individual Eligible Pr ofessionals in a Qualified Clinical Data Registry for the 2016 PQRS Payment Adjustment Section 1848(a)(8) of the Act provides that fo r covered professional services furnished by an eligible professional during 2015 or any subsequent year, if the eligible professional does not satisfactorily report data on quality measures for covered professional services for the quality reporting

### CMS-1600-FC 796

period for the year, the fee schedule amount for servi ces furnished by such professional during the year shall be equal to the applicable percent of the f ee schedule amount that would otherwise apply to such services. For 2016 and subsequent years, the applicable percent is 98.0 percent. Section 1848(m)(3)(D) of the Act, as redesignate d and added by section 601(b) of the ATRA, authorizes the Secretary to treat an individual e ligible professional as satisfactorily submitting data on quality measures under section 1848(m)(A) of the Ac t if, in lieu of reporting measures under section 1848(k)(2)(C) of the Act, the eligible professional is satis factorily participating in a qualified clinical data registry for the year. “Satisfactory participation” is a new standard under the PQRS and is a substitute for the underlying standard of “satisfactory reporting” data on covered professional services that eligible professionals must meet to earn a PQRS incentive or a void the PQRS payment adjustment. Therefore, we proposed to modify § 414.90 to add paragraph (e)(2) to indicate that individual eligible professionals shall be treated as satisfactorily reporting data on quality measures, if the individual eligible professional satisfactorily participates in a qualified clinical data registry (78 FR 43366). We solicited but received no public comment on this proposal. Therefore, we are modifying §414.90 to indicate that individual eligible professionals shall be treated as satisfactorily reporting data on quality measures, if the individual eligible professional satisfactorily participates in a qualified c linical data registry. However, as some of the paragraphs have changed since this proposal, we ar e not indicating this change in paragraph (e)(2). Rather, we are adding paragraph §414.90(k) to indi cate that individual eligible professionals shall be treated as satisfactorily reporting data on quality measures, if the individual eligible professional satisfactorily participates in a qualified clinical data registry. For purposes of the 2016 PQRS payment adjustme nt (which would be based on data reported during the 12-month period that falls in CY 2014), we proposed the exact same requirement we proposed above for satisfactory participation for the 2014 PQRS incentive (78 FR 43366). Specifically, we proposed the following criteria for an individual eligib le professional to meet the criteria for satisfactory participation for the 2016 PQRS payment adjustment : For the 12-month reporting period for the 2016

### CMS-1600-FC 797

PQRS payment adjustment, report at least 9 measures available for reporting under the qualified clinical data registry covering at least 3 of the NQS domains; AND report each measure for at least 50 percent of the eligible professional’s applicable patients. Of the measures reported via a qualified clinical data registry, the eligible professional must report on at least 1 outcome measure (78 FR 43367, Table 25). We solicited and received the following public comme nts on the proposed criterion for the satisfactory participation by individual eligible professionals in a qualified clinical data registry for the 2016 PQRS payment adjustment:

Comment : Several commenters urged CMS to allow the reporting of measures groups under the qualified clinical data registry reporting m echanism for the 2016 PQRS payment adjustment. Response : We agree with the commenters. However, please note that we are not restricting this reporting criterion to individual measures. Rather, as we discuss in greater detail in the PQRS measures section below, a qualified clinical data registry is free to choose which measures its participants will report for purposes of the PQRS. Should a qualified clin ical data registry require its eligible professionals to report on a cluster of measures similar to PQ RS measures groups, the measu res within the measures group would count as separate, individual measures.

Comment : Several commenters supported our proposal to require that an eligible professional report each measure for at least 50 percent of the eligible professional’s applicable patients. The commenters supported our proposal specifically because it aligns with the opti on to report individual

measures via the claims-based re porting mechanism. One commenter, however, opposed this proposal. Instead, the commenter suggested th at CMS allow a qualified clinical data registry to submit its verifiable, statistically supported sampling met hodology to CMS for review and require eligible professionals to report a sufficient number of cases as determined by the individual registry’s sampling requirements. Response : We appreciate the commenters’ positive f eedback. For the suggestion to allow a qualified clinical data registry to submit qualit y measures data based on an approved sampling methodology created by the clinical data registry, we do not believe this is sufficient for the PQRS at this

### CMS-1600-FC 798

time. Particularly since the quality measures data received through the PQRS will be used to assess eligible professionals under the Value-based Payment M odifier, we believe it is important to receive data consistent with the data we are receiving via th e claims and registry-based reporting mechanisms. Therefore, we are finalizing our proposal to use a 50 percent threshold. For the 2016 PQRS payment adjustment, an eligible professional reporting indivi dual quality measures via a qualified clinical data registry will be required to report on at least 3 measu res and report each measure for at least 50 percent of the eligible professional’s applicable patients. Comment : While several commenters generally supported our proposal to require the reporting of more than 3 measures, the commenters believed that requiring the reporting of at least 9 measures covering at least 3 of the NQS domains is too onerous, especially for the PQRS payment adjustment. These commenters suggest ed requiring the reporting of either 4 measures covering at least 1 NQS domain, 5 measures covering at least 2 NQS domains, or 6 measures covering at least 2 NQS domains. Response : We appreciate the commenters’ support for our desire to require the reporting of more than 3 measures to meet the criteria for satisfactory pa rticipation in a qualified clinical data registry for the 2014 PQRS incentive. To be consistent with the criterion we are finalizing for the 2014 PQRS incentive, we are requiring that an eligible professi onal report on at least 9 measures covering at least 3 NQS domains. However, we believe it is appropriate to fi nalize less stringent criteria for the 2016 PQRS payment adjustment, particularly since the qualified c linical data registry is a new reporting mechanism for 2014. We believe this is especially helpful fo r those eligible professionals who use current qualified registries that will seek to become qualified clinical data registries for 2014 that have traditionally reported 3 measures covering 1 domain to meet the cr iteria for satisfactory reporting in the PQRS. Therefore, to be consistent with the the criterion we are finalizing for individual eligible professionals to reporting individual measures registry for the 2016 PQ RS payment adjustment, an individual eligible professional using a qualified clinical data registry may report on at least 3 measures for at least 50 percent of the eligible professional’s applicable patients to satisfy the criteria for satisfactory participation

### CMS-1600-FC 799

in a qualified clinical data registry for the 2016 PQ RS payment adjustment. Please note that it is our intention to fully move towards the reporting of 9 measures covering at least 3 domains to meet the criteria for satisfactory participation for the 2017 PQRS payment adjustment.

Comment : Several commenters opposed our proposal to require that, of the measures reported via a qualified clinical data registry, the eligible pr ofessional must report on at least 1 outcome measure. Some of these commenters noted that, there are many specialties for which outcomes measures may not yet be available, hindering these specialties from partic ipating in the PQRS via a qualified clinical data registry. Response : To be consistent with criterion we are fi nalizing for the 2014 PQRS incentive, if an eligible professional wants to meet the criteria for satisfactory participation for the 2014 PQRS incentive AND 2016 PQRS payment adjustment, we are requiring that an eligible professional who reports at least 9 measures covering at least 3 NQS domains report on at least 1 outcome measure. However, for eligible profe ssionals who only seek to meet the criteria for satisfactory participation for the 2016 PQRS payment adjustment (for example, not seek to earn a 2014 PQRS incentive), we understand that not all entities seeking to become qualified clinical data registries may have outcome measures available for its eligible profe ssionals to report. For example, we understand that registries created for eligible professionals whose pr imary function is to perform imagining scans have found it difficult to develop outcome measures, as outcomes are usually measures not with those particular eligible professionals but by other eligible professionals for which a patient primarily sees. Unlike the PQRS incentive, we belie ve that, for purposes of the 2016 PQRS payment adjustment only, it is appropriate for this initial year not to finali ze the requirement to report an outcome measure. Therefore, if reporting for the 2016 PQRS payment adjustment only and not seeking to earn a 2014 PQRS incentive, if an eligible professional is reporting 3 measures covering at least 1 NQS domain, we will not require an eligible professional to report on at least 1 outcome measure. Please note, however, that it is our intention to require the reporting of 1 outcome measure if reporting via a qualified clinical data registry for the 2017 PQRS payment adjustment. Ther efore, we encourage these registries that do not

### CMS-1600-FC 800

currently require the reporting of an outcome measure to find ways for which an outcome measure may be developed.

Comment : Several commenters generally supported the reporting of measures across multiple NQS domains, as reporting on a variety of measures provi des eligible professionals with a better picture of full continuum of care provided. Response : We agree with the commenters. To be co nsistent with the criterion we are finalizing for the 2014 PQRS incentive, we are requiring that an eligible professional report on measures covering at least 3 NQS domains. However, since we are also finalizing an alte rnative criterion only requiring that an eligible professional using a qualified clinical data registry report on at least 3 measures for the 2016 PQRS payment adjustment, as well as to be consistent with the criterion we finalized for an individual eligible professional reporting individual quality measures via registry for the 2016 PQRS payment adjustment, for purposes of the 2016 PQRS payment adjustment only, we are finalizing a decision to require that an eligible professional using a qualified clinical data re gistry report on at least 3 measures covering only 1 NQS domain.

Comment : Several commenters supported our proposal to implement a MAV process, in the event an eligible professional reports 1—8 measures because less than 9 measures are applicable to the eligible professional. Several of the commenter s sought clarification on how CMS would determine

whether additional measures could be re ported by an eligible professional. Response : We appreciate the commenters’ feedback and support for implementing a MAV process for eligible professionals reporting via a qualifie d clinical data registry. Unfortunately, although we are able to implement a MAV process for the claims and registry-based reporting mechanisms to determine whether an eligible professional could have reported on additional measures, we are unable to implement a similar process for the qualified clini cal data registry-based reporting mechanism as the measures that may be reported via a qualified clinical data registry are not required to be measures found in the PQRS measure set. Unfortunately, we will not receive measure information from clinical data

### CMS-1600-FC 801

registries in time to develop the measure clusters n eeded to implement such a MAV process. Therefore, it would be difficult for CMS to determine appr opriate measure clusters for the MAV process. In summary, based on the comments received and for the reasons explained previously, we are finalizing the following criteria for an individual elig ible professional to meet the criteria for satisfactory participation in a qualified clin ical data registry for the 2016 PQRS payment adjustment: For the 12-month 2016 PQRS payment adjustment reportin g period, report at least 9 measures covering at least 3 NQS domains AND report each measure for at least 50 percent of the applicable patients seen during the reporting period to which the measure app lies. Measures with a 0 percent performance rate would not be counted. Of the measures reported via a qualified clinical data registry, the eligible professional must report on at least 1 outcome measure; OR For the 12-month 2016 PQRS payment adjustment reporting period, report at least 3 measures covering at least 1 NQS domain AND report each measure for at least 50 percent of the applicable patients seen during the reporting period to which th e measure applies. Measures with a 0 percent performance rate would not be counted. Tables 47 and 48 provide a summary of the fi nal criteria for satisfactory reporting and satisfactory participation we discussed above for i ndividual eligible professionals for the 2014 PQRS incentive and 2016 PQRS paymen t adjustment, respectively.

### CMS-1600-FC 802

TABLE 47: Summary of Requirements for the 2014 PQRS Incentive: Individual Reporting Criteria for Satisfactory Reporting of Individual Quality Measures via Claims, Qualified Registries, and EHRs and Satisfactory Participation Criteri on in Qualified Clinical Data Registries

Reporting Period Measure Type Reporting Mechanism Satisfactory Reporting Criter ia/Satisfactory Participation Criterion 12-month (Jan 1 — Dec 31) Individual Measures Claims Report at least 9 measures co vering at least 3 NQS domains, OR, if less than 9 measures covering at least 3 NQS domains apply to the eligible professional, report 1—8 measures covering 1—3 NQS domains, AND report each measure fo r at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measur es with a 0 percent performance rate would not be counted. * For an eligible professional who reports fewer than 9 measures covering 3 NQS domains via the claims-based reporting mechanism, the eligible professional will be subject to the MAV process, which would allow us to determine whether an eligible professional should have reported quality data codes for additional measures and/or covering additional NQS domains.

12-month (Jan 1 — Dec 31) Individual Measures Qualified Registry Report at least 9 measures covering at least 3 of the NQS domains, OR, if less than 9 measures covering at least 3 NQS domains apply to the eligible professional, report 1—8 measures covering 1-3 NQS domains for which there is Medicare patient data, AND report each measure for at least 50 percent of the eligible professional’s Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measur es with a 0 percent performance rate would not be counted. * For an eligible professional who reports fewer than 9 measures covering 3 NQS domains via the registry-based reporting mechanism, the eligible professional will be subject to the MAV process, which would allow us to determine whether an eligible professional should have reported on additional measures and/or measures covering additional NQS domains.

** 12-month (Jan 1 — Dec 31) Individual Measures Direct EHR product that is CEHRT and EHR data submission vendor that is CEHRT Report 9 measures covering at l east 3 of the NQS domains. If an eligible professional's CEHRT does not contain patient data for at least 9 measures covering at least 3 domains, then the eligible professional must report the meas ures for which there is Medicare patient data. An eligible professional must report on at least 1 measure for which there is Medicare patient data. ** 12-month (Jan 1 — Dec 31) Measures Groups Qualified Registry Report at least 1 measures grou p, AND report each measures group for at least 20 patients, a majority of which much be Medicare Part B FFS patients. ** 6-month Measures Qualified Report at least 1 measures group, AND report each measures group

### CMS-1600-FC 803

Reporting Period Measure Type Reporting Mechanism Satisfactory Reporting Criter ia/Satisfactory Participation Criterion (Jul 1 – Dec 31) Groups Registry for at least 20 patients, a majority of which much be Medicare Part B FFS patients.

12-month (Jan 1 — Dec 31) Measures selected by Qualified Clinical Data Registry Qualified Clinical Data Registry Report at least 9 measures cove ring at least 3 NQS domains AND report each measure for at least 50 percent of the eligible professional’s applicable patients seen during the reporting period to which the measure applies. Measur es with a 0 percent performance rate would not be counted. Of the measures reported via a qua lified clinical data registry, the eligible professional must report on at least 1 outcome measure. *Subject to the MAV process. ** Finalized in the CY 2013 PFS final rule (see Table 91 at 77 FR 69194). TABLE 48: Summary of Requirements for the 2016 PQRS Payment Adjustment: Individual

Reporting Criteria for Satisfactory Reportin g of Individual Quality Measures via Claims, Registries, and EHRs and Satisfactory Participation Criterion in Qualified Clinical Data Registries

Reporting Period Measure Type Reporting Mechanism Satisfactory Reporting Criter ia/Satisfactory Participation Criterion 12-month (Jan 1 — Dec 31) Individual Measures Claims Report at least 9 measures co vering at least 3 NQS domains, OR, if less than 9 measures covering at least 3 NQS domains apply to the eligible professional, report 1—8 measures covering 1—3 NQS domains, AND report each measure fo r at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measur es with a 0 percent performance rate would not be counted. * For an eligible professional who reports fewer than 9 measures covering 3 NQS domains via the claims-based reporting mechanism, the eligible professional will be subject to the MAV process, which would allow us to determine whether an eligible professional should have reported quality data codes for additional measures and/or covering additional NQS domains.

** 12-month (Jan 1 — Dec 31) Individual Measures Claims Report at least 3 measures, OR, If less than 3 measures apply to th e eligible professional, report 1— 2 measures*; AND Report each measure for at least 50 percent of the eligible professional’s Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent perfor mance rate will not be counted. 12-month (Jan 1 — Dec 31) Individual Measures Qualified Registry Report at least 9 measures covering at least 3 of the NQS domains, OR, if less than 9 measures covering at least 3 NQS domains apply to the eligible professional, report 1—8 measures covering 1-3 NQS domains for which there is Medicare patient data, AND report each

### CMS-1600-FC 804

Reporting Period Measure Type Reporting Mechanism Satisfactory Reporting Criter ia/Satisfactory Participation Criterion measure for at least 50 percent of the eligible professional’s Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measur es with a 0 percent performance rate would not be counted. * For an eligible professional who reports fewer than 9 measures covering at least 3 NQS domains via the registry-based reporting mechanism, the eligible professional will be subject to the MAV process, which would allow us to determine whether an eligible professional should have reported on additional measures and/or measures covering additional NQS domains.

12-month (Jan 1 — Dec 31) Individual Measures Qualified Registry Report at least 3 measures covering at least 1 of the NQS domains, OR, if less than 3 measures apply to the eligible professional, report 1—2 measures covering at least 1 NQS domain for which there is Medicare patient data, AND report each measure for at least 50 percent of the eligible professional’s Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent performan ce rate would not be counted. * For an eligible professional who reports fewer than 3 measures covering 1 NQS domain via the registry-based reporting mechanism, the eligible professional will be subject to the MAV process, which would allow us to determine whether an eligible professional should have reported on additional measures.

** 12-month (Jan 1 — Dec 31) Individual Measures Direct EHR product that is CEHRT and EHR data submission vendor that is CEHRT Report 9 measures covering at l east 3 of the NQS domains. If an eligible professional's CEHRT does not contain patient data for at least 9 measures covering at least 3 domains, then the eligible professional must report the meas ures for which there is Medicare patient data. An eligible professional must report on at least 1 measure for which there is Medicare patient data. ** 12-month (Jan 1 — Dec 31) Measures Groups Qualified Registry Report at least 1 measures grou p, AND report each measures group for at least 20 patients, a majority of which much be Medicare Part B FFS patients.

** 6-month (Jul 1 – Dec 31) Measures Groups Qualified Registry Report at least 1 measures grou p, AND report each measures group for at least 20 patients, a majority of which much be Medicare Part B FFS patients.

12-month (Jan 1 — Dec 31) Measures selected by Qualified Clinical Data Registry Qualified Clinical Data Registry Report at least 9 measures cove ring at least 3 NQS domains AND report each measure for at least 50 percent of the eligible professional’s applicable patients seen during the reporting period to which the measure applies. Measur es with a 0 percent performance rate would not be counted. Of the measures reported via a qua lified clinical data registry, the

### CMS-1600-FC 805

Reporting Period Measure Type Reporting Mechanism Satisfactory Reporting Criter ia/Satisfactory Participation Criterion eligible professional must report on at least 1 outcome measure.

12-month (Jan 1 — Dec 31) Measures selected by Qualified Clinical Data Registry Qualified Clinical Data Registry Report at least 3 measures cove ring at least 1 NQS domain AND report each measure for at least 50 percent of the eligible professional’s applicable patients seen during the reporting period to which the measure applies. Measur es with a 0 percent performance rate would not be counted. *Subject to the MAV process. ** Finalized in the CY 2013 PFS final rule (see Table 91 at 77 FR 69194). 7. Criteria for Satisfactory Reporting for the 2014 PQRS Incentive for Group Practices in the GPRO For 2014, in accordance with §414. 90(c)(3), eligible professionals that satisfactorily report data on PQRS quality measures are eligible to receive an in centive equal to 0.5 percent of the total estimated Medicare Part B allowed charges for all covered professional services furnished by the eligible professional or group practice during the applicable reporting period. We finalized criteria for the satisfactory reporting for group practices participating in the GPRO for the 2014 PQRS incentive in the CY 2013 PFS final rule with comment period ( see Table 93, 77 FR 69195). In the CY 2014 PFS proposed rule, we proposed to change some of the criteria for satisfactory reporting for group practices under the GPRO using the registry and GPRO web interface reporting mechanisms (78 FR 43368). Group practices may currently report PQRS quality measures data to meet the criteria for satisfactory reporting for the 2014 PQRS incentive vi a the registry, EHR, and GPRO web interface reporting mechanisms. First, for the 2014 PQRS incen tive, we previously finalized the following criterion for the satisfactory reporting of PQRS quality me asures via the GPRO web interface for group practices comprised of 25-99 eligible professionals: Report on all measures included in the web interface; AND populate data fields for the first 218 consecutively rank ed and assigned beneficiaries in the order in which they appear in the group’s sample for each module or preventive care measure. If the pool of eligible assigned beneficiaries is less than 218, then repor t on 100 percent of assigned beneficiaries (77 FR 69195). To streamline the PQRS and eliminate repor ting options that are largely unused, in the CY 2014 PFS proposed rule, we proposed to eliminate this cr iterion under the GPRO for the 2014 PQRS incentive.

### CMS-1600-FC 806

As a result, group practices composed of 25-99 eligib le professionals would no longer have the option to report PQRS quality measures using the GPRO we b interface for the 2014 PQRS incentive (78 FR 43368). We solicited and received the fo llowing public comments on this proposal:

Comment : Several commenters opposed our proposal to eliminate the option for group practices comprised of 25-99 eligible professionals to report PQRS quality measures using the GPRO web interface for the 2014 PQRS incentive. The commenters request that, although there has been low participation in this reporting option, we keep this option for at least one more year. The commenters believe that group practices may increasingly use this option, particular ly as the PQRS moves from an incentive-based to a program that solely provides payment adjustments. Response : While we proposed to eliminate this repor ting option due to low participation, we agree with the commenters. We understand that ot her commenters expressed similar concerns with our proposal to eliminate the option to report PQRS meas ures groups via registry, yet we are still finalizing our proposal to eliminate the option to report PQ RS measures groups via registry for the 2014 PQRS incentive and 2016 PQRS payment adjustment. Unlik e the option to report PQRS measures groups via registry, the option for group practices comprised of 25-99 eligible professionals to report PQRS quality measures using the GPRO web interface is relativel y new as it was finalized in the CY 2013 PRS final rule with comment period (77 FR 69196). As such, we are willing to keep the option for group practices comprised of 25-99 eligible professionals to report PQRS quality measures using the GPRO web interface for the 2014 PQRS incentive to see whether PQRS participation using this reporting criterion will increase. Therefore, we are not finalizing our prop osal to eliminate this GPRO reporting option. However, we note that should we continue to see lo w participation in this reporting criterion, we may propose to eliminate this reporting criterion again in future rulemaking.

In the CY 2013 PFS final rule with comment period, for reporting under the GPRO using the registry-based reporting mechanism, we finalized the following criterion for the satisfactory reporting of PQRS quality measures for group practices composed of 2 or more eligible professionals for the 2014 PQRS incentive: Report at least 3 measures, AND report each measure for at least 80 percent of the group

### CMS-1600-FC 807

practice’s Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent performance rate will not be counted (77 FR 69196). For the same reasons we proposed to increase the number of measures an indi vidual eligible must report, as well as decrease the percentage threshold for individua l eligible professionals reporting via registry for the 2014 PQRS incentive in the CY 2014 PFS proposed rule, we pro posed the following modified criteria for the satisfactory reporting of individual quality measure s under the GPRO for the registry-based reporting mechanism: Report at least 9 measures covering at least 3 of the NQS domains; AND report each measure for at least 50 percent of the group practi ce’s applicable seen during the reporting period to which the measure applies. Measures with a 0 pe rcent performance rate will not be counted (78 FR 43368). We solicited and received the fo llowing public comments on this proposal:

Comment : The majority of commenters supported ou r proposal to decrease the percentage of patients that must be reported via registry from 80 percent to 50 percent. The commenters supported our proposal specifically because this threshold aligns wi th the option to report individual measures via the claims-based reporting mechanism. Response : We appreciate the commenters’ feedback and, based on the support received and for the reasons stated previously, we are finalizing th is proposal for reducing the reporting threshold. Therefore, for the 2014 PQRS incentive, a group practice reporting individual quality measures via registry will be required to report each measure for at least 50 percent of the eligible professional’s Medicare Part B FFS patients seen during the reporting pe riod to which the measure applies. Please note, however, that as the program evolves, we anticipate increasing the reporting threshold again both for the registry-based reporting mechanism.

Comment : Several commenters supported our proposal to increase the number of measures to be reported via registry to 9, as requiring a group prac tice to report on more measures would better capture the quality of care provided by a group practice. Ho wever, while several comme nters generally supported our proposal to increase the number of measures to be reported via registry, the commenters urged CMS to provide a more gradual approach to increasing the number of measures that must be reported via

### CMS-1600-FC 808

registry. These commenters suggested requiring the reporting of either 4 measures covering at least 1 NQS domain, 5 measures covering at least 2 NQS domains, or 6 measures covering at least 2 NQS

domains. The majority of commenters opposed our proposal to increase the number of measures to be reported via registry from 3 to 9. Several of these commenters generally opposed any proposal that would increase the number of measures to be reported via registry from 3. Some of these commenters urged CMS not to increase the criteria for satisfactory repor ting until participation in PQRS increases, as the commenters feared that increasing the criteria for satisfactory reporting in PQRS would discourage eligible professionals from participating in the PQRS. Still some of these commenters opposing this proposal noted that certain eligible professionals did not have 9 measures for which to report. Response : We appreciate commenters’ positive f eedback, as well as suggested alternative reporting criteria. We understand the commenters’ concerns opposing this proposal. However, we believe that it is important to collect data that provi des a broad picture of the quality of care provided by a group practice, and, as discussed in section K of this final rule with comment period, such information will be used, in part, for the Value-based Payment M odifier to determine upwar d, downward, and neutral adjustments based on physician performance. So we belie ve it is important to raise the measure threshold from 3 measures covering 1 NQS domain to 9 measur es covering 3 NQS domains. As we noted above and in the proposed rule (78 FR 43368), we believe that we have provided group practices with enough time to familiarize themselves with the reporting options for satisfactory reporting under the PQRS, particularly for the PQRS incentives. For the commenters who urge us not to increase the satisfactory reporting criteria for the PQRS until participation in PQRS increases, we understand that , as discussed in this final rule below and in the 2011 PQRS and eRx Reporting Experience, participati on in the PQRS has fluctuated around 25 percent among those eligible to participate in the PQRS. Indeed, it is one of our major goals to increase participation in the PQRS. While increasing the satisfactory reporting threshold for the 2014 PQRS incentive may deter or discourage eligible professionals from participating, we believe the increase we

### CMS-1600-FC 809

proposed for the satisfactory reporting threshold will no t significantly deter eligib le professionals in group practices from participating in the PQRS. Also, we note that eligible professionals in group practices will be required to report PQRS quality measures data to m eet the criteria for satisfactory reporting for the 2016 PQRS payment adjustment, the reporting periods of which run concurrently with the reporting periods for the 2014 PQRS incentive. Since eligible professionals will already be required to meet the criteria for satisfactory reporting for the 2016 PQRS payment adjustment, we believe these eligible professionals will also attempt to report for the 20 14 PQRS incentive regardless of whether we increase the measure threshold from 3 measures covering 1 NQS domain to 9 measures covering 3 NQS domains. But to addres the commenters’ concerns about not having at least 9 PQRS measures covering 3 NQS domains for which to report via registry, we ar e modifying what we are finalizing to allow group practices to report fewer measures so that group pr actices who do not have at least 9 PQRS measures applicable to their practice. Specifically, if fe wer than 9 measures covering less than 3 NQS domains apply to the group practice, a group practice must report 1-8 measures covering 1-3 NQS domains for which there is Medicare patient data. Given this ch ange to the criterion, we will apply a MAV process, which will be triggered when a group practice reports on l ess than 9 measures. This is consistent with our practice for applying this process to the claims-based reporting option fo r individuals to report individual measures. For example, if a group practice reports on 8 measures covering 2 NQS domains, the MAV process will be triggered to determine whether a group practice could have reported on an additional measure and/or covering an additional domain. The 2014 registry MAV process that will determin e whether a group practice could have reported on more measures and/covering more NQ S domains will be similar to the “clinical relation” test used in the 2013 claims MAV process. To get a better sen se of how the 2014 registry MAV process will be implemented by CMS, a description of the “clinical relation” test in the current 2013 claims MAV process is available at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/PQRS/Downloads/2013_PQRS_Measu reApplicabilityValidation_Docs_030413.zip . Please note that we will post a guidance document on the 20 14 registry MAV process, which will include a list

### CMS-1600-FC 810

of the measure clusters that are used for the “clinical relation” test, prior to January 1, 2014 (the start of the 2014 reporting periods). We believe modifying the reporting criterion will address commenters concerns, while still maintaining our general goal of increasing the meas ures reported to 9 measures covering 3 NQS domains. This also will increase the likelihood that more elig ible professionals, including those in group practices, will be able to take advantage of this reporting option. For the reasons stated above, we are finalizing the following criterion for group practices in the GPRO reporting individual PQRS quality measures via registry for the 2014 PQRS incentive: For the 12- month reporting period for the 2014 PQRS incentive, report at least 9 measures covering at least 3 of the NQS domains, OR, if less than 9 measures covering at least 3 NQS domains apply to the group practice, report 1—8 measures covering 1-3 NQS domains for which there is Medicare patient data, AND report each measure for at least 50 percent of the group pr actice’s Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measu res with a 0 percent performance rate would not be counted. For a group practice who reports fewer than 9 measures covering less than 3 NQS domains via the registry-based reporting mechanism, the group prac tice would be subject to the MAV process, which would allow us to determine whether a group practi ce should have reported on a dditional measures and/or measures covering additional NQS domains. Third, under our authority under section 1848(m)(3)(C)(i) of the Act to select the measures for which a group practice must report, based on our desi re to encourage the use of patient surveys to assess beneficiary experience of care and outcomes, we proposed to provide group practices composed of 25 or more eligible professionals with a new satisfactory re porting criterion that would include the option to complete the CG CAHPS survey along with repor ting 6 other PQRS measures for purposes of meeting the criteria for satisfactory reporting for the 2014 PQRS incentive and 2016 PQRS payment adjustment (78 FR 43368). We further proposed that the survey would be administered following the close of the PQRS registration period. We indicated that CMS would provide each group a detailed report about the results

### CMS-1600-FC 811

of the survey. In addition, we proposed to assi gn beneficiaries to a group practice using the same assignment methodology that we use for the GPRO web interface (77 FR 69195). This method focuses on assigning beneficiaries to a group based on whether the group provided the plurality of primary care services. Because we proposed to assign beneficiaries to a group based on the provision of primary care services, we noted that this survey is not an appr opriate option for groups of physicians (for example, such as a group of surgeons) that do not provide primary care services. In accordance with section 1848(m)(3)(C)(ii) of the Act, which requires the GPRO to provide for the use of a statistical sampling model, we propose that the survey would be admini stered by certified survey vendor on behalf of the group practice for a sample of group’s assigned beneficiari es. As noted earlier, to complete this survey, a group practice must indicate its intent to report the CG CAHPS survey when it registers to participate in the PQRS via the GPRO. Please note that the CAHPS survey measures only co ver 1 NQS domain. To be consistent with other group practice reporting criteria we proposed to require the reporting of measures covering at least 3 NQS domains, we proposed that, unless a group prac tice is comprised of 100 or more eligible professionals and is participating in the PQRS via the GPRO web interface, if a group practice comprised of 25 of more eligible professionals reports the CA HPS measures via a certified survey vendor, the group practice would be required to report on at least 6 additional measures covering at least 2 NQS domains. Specifically, we proposed the following criteria for satisfactory reporting for the 2014 PQRS incentive: For the 12-month reporting period for th e 2014 PQRS incentive, report all CAHPS survey measures via a certified vendor, AND report at least 6 measures covering at least 2 of the NQS domains using the qualified registry, direct EHR product, EHR data submission vendor, or GPRO web interface reporting mechanisms (78 FR 43368). We solicited and received the following pub lic comments on our proposed criterion for the satisfactory reporting of data on these PQRS qua lity measures under the GPRO for the 2014 PQRS

incentive:

### CMS-1600-FC 812

Comment : Although one commenter supported the proposal to allow all group practices of 25 or more eligible professionals in the GPRO to repor t the CG CAHPS survey measures for the 2014 PQRS incentive, since the cost to do the survey will be at the practice’s expense, the commenter appreciate CMS’ proposal to make this optional for practices. Response : We appreciate the commenter’s response. Unfortunately, except for group practices comprised of 100 or more eligible professionals in the GPRO that are using the GPRO web interface reporting mechanism who must report the CG CAHPS measures (77 FR 69267) to meet the criteria for satisfactory reporting for the 2014 PQRS incentive, we cannot bear the cost of administering the CG CAHPS survey to group practices. However, in the interest of encouraging the administering and reporting of CG CAHPS data, we proposed this alte rnative reporting criterion for which group practices may use to meet the criteria for satisfactory repor ting for the 2014 PQRS incentive. Since CMS cannot bear the cost of administering the CG CAHPS su rvey for these group practices, the reporting of CG CAHPS measures is optional for the purpose of meeting the criteria for satisfactory reporting for the 2014 PQRS incentive except for group practices comprised of 100+ eligible professionals who are reporting PQRS measures via the GPRO web interface.

Comment : Some commenters opposed our proposal to require the reporting of 6 measures covering at least 2 of the NQS domains using the qualified registry, direct EHR product, EHR data submission vendor, or GPRO web interface reporting mech anisms in addition to the CG CAHPS survey. Commenters felt this proposed criterion was too onerous, especially given the time and expense associated with administering the CG CAHPS survey. Response : We understand the commenters’ concerns w ith this proposal. However, we believe requiring the reporting of 6 measures covering at least 2 of the NQS domains using the qualified registry, direct EHR product, EHR data submission vendor, or GPRO web interface reporting mechanisms in addition to the CG CAHPS survey is fair. The CG CAHPS survey measure only satisfies the reporting of 1 NQS domain, while other group practice criteria we have established for the registry and EHR-based reporting mechanisms for the 2014 PQRS incentive requi re the reporting of measures in at least 3 NQS

### CMS-1600-FC 813

domains to meet the criteria for satisfactory reporting for the 2014 PQRS incentive. In addition, we note that requiring the reporting of 6 measures in add ition to the CG CAHPS survey would essentially require a group practice to report on 6 measures and 12 surv ey questions, for a total of 18 measures and questions. We note that this is the same number of measures (18) that we currently require group practices in the GPRO to report via the GPRO web interface. Based on the comments received and for the reasons stated previously, we are finalizing the following criterion for a group practice comprised of 25 or more eligible professionals who chooses to comple te the CG CAHPS survey in conjunction with the qualified registry, direct EHR product, EHR data submission vendor, or GPRO web-interface reporting mechanisms: For the 12-month reporting period for the 2014 PQRS incentive, report all CAHPS survey measures via a certified vendor, AND report at least 6 measures covering at least 2 of the NQS domains using the qualified registry, direct EHR product, EHR data submission vendor, or GPRO web interface reporting mechanisms. We are modifying § 414.90(h) to indicate this reporting criterion. 8. Criteria for Satisfactory Reporting for the 2016 PQRS Payment Adjustment for Group Practices in the

GPRO This section addresses the certain proposals we made regarding criteria for satisfactory reporting for group practices in the GPRO for the 2016 PQRS payment adjustment using the registry, GPRO web interface, and certified survey vendor reporting m echanisms. In the CY 2013 PFS final rule with comment period, we finalized the same criteria for satisfactorily reporting data on quality measures for the 2016 PQRS payment adjustment that apply for the 2014 PQRS incentive for the PQRS GPRO (77 FR 69200). In the CY 2014 PFS proposed rule, we made three of the same proposals for the criteria for satisfactory reporting under the GPRO for the 2016 PQRS payment adjustment that we are proposed for the 2014 PQRS incentive (78 FR 43369). Specifically, to coincide with our proposals fo r the 2014 PQRS incentive, we first proposed (78 FR 43369) to eliminate the following criterion for satisfactory reporting of PQRS quality measures via the GPRO web interface for group practices comprised of 25-99 eligible professi onals: Report on all measures included in the web interface; AND populate da ta fields for the first 218 consecutively ranked

### CMS-1600-FC 814

and assigned beneficiaries in the order in which they appear in the group’s sample for each module or preventive care measure. If the pool of eligible assigned beneficiaries is less than 218, then report on 100 percent of assigned beneficiaries. We solicited and received the following public comments on this proposal:

Comment : Several commenters opposed our proposal to eliminate the option for group practices comprised of 25-99 eligible professionals to report PQRS quality measures using the GPRO web interface for the 2014 PQRS incentive. The commenters request that, although there has been low participation in this reporting option, we keep this option for at least one more year. The commenters believe that group practices may increasingly use this option, particular ly as the PQRS moves from an incentive-based to a program that solely provides payment adjustments. Response : We appreciate the commenters’ feedback and understand the commenters’ concerns. Since we are not finalizing our proposal to eliminat e this reporting criterion for the 2014 PQRS incentive,

to coincide with the criterion established for the 20 14 PQRS incentive and for the same reasons we are not finalizing our proposal to remove this reporti ng criterion for the 2014 PQRS incentive, we are not finalizing our proposal to remove this reporting criteri on. As we previously stated, although we proposed to eliminate this reporting criterion due to low partic ipation, we are willing to keep the option for group practices comprised of 25-99 eligible professionals to report PQRS quality measures using the GPRO web interface for the 2014 PQRS incentive to see wh ether PQRS participati on using this reporting criterion will increase. However, we note that shoul d we continue to see low participation in this reporting criterion, we may propose to eliminate this reporting criterion again in future rulemaking. Based on the comments received and for the reasons pr eviously stated, group practices of 25-99 eligible professionals have the option to use the following cr iterion for satisfactory reporting of PQRS quality measures via the GPRO web interface: Report on all measures included in the web interface; AND populate data fields for the first 218 consecutively rank ed and assigned beneficiaries in the order in which they appear in the group’s sample for each module or preventive care measure. If the pool of eligible assigned beneficiaries is less than 218, then report on 100 percent of assigned beneficiaries.

### CMS-1600-FC 815

Second, we proposed to remove the following cr iterion for satisfactory reporting via registry under the GPRO for the 2016 PQRS payment adjustme nt: Report at least 3 measures, AND report each measure for at least 80 percent of the group pr actice’s Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measu res with a 0 percent performance rate will not be counted (78 FR 43369). By eliminating this optio n as proposed, a group practice reporting via registry would have been required to meet the same criteri a for satisfactory reporting for the 2014 PQRS incentive as the 2016 PQRS payment adjustment. This would allow us to maintain consistent criteria for the 2016 PQRS payment adjustment and 2014 PQRS incentive. We solicited and received the following public comments on this proposal:

Comment : While several commenters supported our proposal to increase the number of measures to be reported via registry, these commenters gene rally did not support eliminating this reporting criterion. Other commenters expressed concern th at there are still group practices who do not have 3 measures applicable to their practice. These comme nters therefore suggested that this criterion be modified to require the reporting of only 1 measure covering 1 NQS domain for the 2016 PQRS payment adjustment, similar to the criterion that was finaliz ed for the 2015 PQRS payment adjustment (77 FR 69200), as some commenters are concerned that th ere are still group practices who do not have 3 measures applicable to their practice. Response : We understand the commenters’ concerns regarding eliminating this reporting criterion. Although we still desire to move toward s the reporting of more measures, we understand that eligible professionals may need another year to adjust to the reporting of additio nal measures. We believe it is pertinent to allow time for eligible professionals to adjust to the reporting of additional measures for purposes of the 2016 PQRS payment adjustment as oppo sed to the 2014 PQRS incentive, where forgoing reporting has no downward payment consequencee. Therefore, based on the concerns expressed by commenters, we are not finalizing our proposal to eliminate this reporting criterion for the 2016 PQRS payment adjustment, but as noted below, are further m odifying the criterion in this final rule. We note,

### CMS-1600-FC 816

however, that it is our intention to move towards the reporting of 9 measures covering at least 3 NQS domains for the 2017 PQRS payment adjustment.

To address commenters concerns and to coincide with the percentage reporting threshold we are finalizing for group practices who report individual m easures via registry for the 2014 PQRS incentive, we are lowering the percentage threshold for the re porting of measures via registry for the 2016 PQRS payment adjustment from 80 to 50 percent. We believe this modification reduces reporting burden on group practices since they will be required to report on less patients. This further aligns with some the reporting criteria for the 2014 PQRS incentive criteria. For the commenters who expressed concern that there are still group practices who do not have 3 measures applicable to their practice, we are fi nalizing another modification to allow eligible professionals to report 1-2 applicable measures. A nd consistent with the ot her final policies we are adopting, we will apply a registry MAV process for the 2016 PQRS payment adjustment. For purposes of this reporting criterion, the registry MAV process will be triggered when a group practice reports on less than 3 measures. For example, if a group practi ce reports on 1—2 measures, the MAV process will be triggered to determine whether a group practice coul d have reported on at least 3 measures covering 1 NQS domain. We believe implementing this cha nge to the criterion for the 2016 PQRS payment adjustment will help to alleviate commenters’ con cerns that certain group practices may not have a sufficient number of measures to report covering a sufficient amount of NQS domains. This registry MAV process that will determine whether a group practice could have reported on

more measures will be similar to the “clinical relation” test used in the 2013 claims MAV process. To get a better sense of how the registry MAV process for the 2016 PQRS payment adjustment will be implemented by CMS, a description of the “clinical relation” test in the current 2013 claims MAV process is available at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/PQRS/Downloads/2013_PQRS_Measu reApplicabilityValidation_Docs_030413.zip . Please note that we will post a guidance document on the registry MAV process for the 2016 PQRS payment

### CMS-1600-FC 817

adjustment, which will include a list of the measure clus ters that are used for the “clinical relation” test, prior to January 1, 2014 (the start of the 2014 reporting periods). In summary, we are finalizing in the following criterion for satisfactory reporting via registry under the GPRO for the 2016 PQRS payment adjustme nt: For the 12-month reporting period for the 2016 PQRS payment adjustment, report at least 3 measures covering at least 1 of the NQS domains, OR, if less than 3 measures apply to the group practice, repor t 1—2 measures covering at least 1 NQS domain for which there is Medicare patient data, AND report each measure for at least 50 percent of the group practice’s Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent performance rate would no t be counted. For a group practice who reports fewer than 3 measures via the registry-based reporting mechanism, the group practice would be subject to the MAV process, which would allow us to determ ine whether a group practice should have reported on

additional measures. Third, to coincide with criterion we are finaliz ing for the 2014 PQRS incentive, we proposed (78 FR 43369) the following criterion for satisfactory repo rting of measures via registry under the GPRO for the 2016 PQRS payment adjustment: Report at least 9 measures covering at least 3 of the National Quality Strategy domains, and report each measure for at least 50 percent of the group practice’s applicable patients seen during the reporting period to which the measure applies. Measures with a 0 percent performance rate will not be counted.

Comment : Several commenters generally supported our proposal to align the satisfactory reporting criteria for the 2014 PQRS incentive with th e satisfactory reporting criteria for the 2016 PQRS payment adjustment. Response : We appreciate the commenters’ support. However, given that we are making certain changes to address concerns raised above and with regard to the 2014 incentive about increasing the number of measures to 9 and whether eligible professi onals have enough applicab le measures to report to take advantage of this reporting criterion, we are finalizing a modification of the criterion that was proposed for the satisfactory reporting of measures via registry under the GPRO for the 2014 PQRS

### CMS-1600-FC 818

incentive. This will also help to meet our goal of aligment under the program where possible with regard to various reporting criteria. Specifically, we are finalizing the following criterion for satisfactory reporting via registry under the GPRO for the 2016 PQRS payment adjustment: Repor t at least 9 measures covering at least 3 of the NQS domains, OR, if less than 9 measures covering at least 3 NQS domains apply to the group practice, report 1—8 measures covering 1-3 NQS domains for which there is Medicare patient data, AND report each measure for at least 50 percent of the group pr actice’s Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measu res with a 0 percent performance rate would not be counted. For a group practice who reports fewer than 9 measures covering less than 3 NQS domains via the registry-based reporting mechanism, the group prac tice would be subject to the MAV process, which would allow us to determine whether a group practi ce should have reported on a dditional measures and/or measures covering additional NQS domains. Fourth, consistent with the proposal we made to provide group practices comprised of 25 or more eligible professionals with a new satisfactory reportin g criterion that would include the option to complete the CG CAHPS survey along with reporting 6 other PQRS measures for purposes of meeting the criteria for satisfactory reporting for the 2014 PQRS incentiv e, we also proposed the same criterion for purposes of meeting the criteria for satisfactory reporting fo r the 2016 PQRS payment adjustment. Specifically, we proposed the following criteria for satisfactory re porting for the 2016 PQRS payment adjustment: For the 12-month reporting period for the 2016 PQRS payment adjustment, report all CAHPS survey measures via a certified vendor, AND report at least 6 measures covering at least 2 of the NQS domains using the qualified registry, direct EHR product, EHR data submission vendor, or GPRO web interface reporting mechanisms. As noted earlier, to complete th is survey, a group practice must indicate its intent to report the CG CAHPS survey when it registers to participate in the PQRS via the GPRO (78 FR 43369). We solicited and received the following public comments on this proposed criterion:

Comment : Although one commenter supported the proposal to allow all group practices of 25 or more eligible professionals in the GPRO to report th e CG CAHPS survey measures, since the cost to do

### CMS-1600-FC 819

the survey will be at the practice’ s expense, the commenter apprecia tes CMS’ proposal to make this optional for practices. Response : We appreciate the commenter’s response. However, although this reporting criterion is generally optional for group practices of 25 or more eligible professionals, please note that completion of the CG CAHPS survey it not optional for all gr oup practices participating under the GPRO for the 2016 PQRS payment adjustment. As we stated in the CY 2013 PFS final rule with comment period, all group practices comprised of 100 or more eligible pr ofessionals in the GPRO that are using the GPRO web interface reporting mechanism must report the CG CAHPS measures (77 FR 69267) to meet the criteria for satisfactory reporting for the 2014 PQRS incentive. Since, as finalized in the CY 2013 PFS final rule with comment period (77 FR 69200), a gr oup practice may meet the criteria for satisfactory reporting for the 2016 PQRS payment adjustment by mee ting the criteria for satisfactory reporting for the 2014 PQRS incentive, all group practices comprised of 100 or more eligible professionals in the GPRO that are using the GPRO web interface reporting mechanism must also report the CG CAHPS measures (77 FR 69267) to meet the criteria for satisfactory reporting for the 2016 PQRS payment adjustment. Because we are requiring these group practices to repor t the CG CAHPS survey measures, we noted that CMS would bear the cost of administering the survey. Nonetheless, we are pleased with the comment er’s support with making reporting of the CG CAHPS survey measures optional for the 2014 PQRS in centive. We understand that it is a considerable expense to administer the CG CAHPS survey. Since CMS cannot bear the cost of administering the CG CAHPS survey for these group practices, the reportin g of CG CAHPS measures is optional for the purpose of meeting the criteria for satisfactory repor ting for the 2016 PQRS payment adjustment except for group practices comprised of 100+ eligible professionals who are reporting PQRS measures via the

GPRO web interface.

Comment : Some commenters opposed our proposal to require the reporting of 6 measures covering at least 2 of the NQS domains using the qualified registry, direct EHR product, EHR data submission vendor, or GPRO web interface reporting mech anisms in addition to the CG CAHPS survey.

### CMS-1600-FC 820

Commenters felt this proposed criterion was too onerous, especially given the time and expense associated with administering the CG CAHPS survey. Response : We understand the commenters’ concerns w ith this proposal. However, we believe requiring the reporting of 6 measures covering at least 2 of the NQS domains using the qualified registry, direct EHR product, EHR data submission vendor, or GPRO web interface reporting mechanisms in addition to the CG CAHPS survey is fair. The CG CAHPS survey measure only satisfies the reporting of 1 NQS domain, while most other group practice criter ia we have established for the registry and EHRbased reporting mechanisms require the reporting of measures in at least 3 NQS domains to meet the criteria for satisfactory reporting for the 2016 PQRS payment adjustment. In addition, we note that requiring the reporting of 6 measures in addition to the CG CAHPS survey would essentially require a group practice to report on 6 measures and 12 survey qu estions, for a total of 18 measures and questions. We note that this is the same number of measures (1 8) that we currently require group practices in the GPRO to report via the GPRO web interface. Based on the comments received and for the reasons stated previously, we are finalizing the following criterion – wh ich is identical to the criterion finalized for the 2014 PQRS incentive – for a group practice who c hooses to complete the CG CAHPS survey in conjunction with the qualified registry, direct EHR product, EHR data submissi on vendor, or GPRO webinterface reporting mechanisms for the 2016 PQRS payment adjustment: For the 12-month reporting period for the 2014 PQRS incentive, report all C AHPS survey measures via a certified vendor, AND report at least 6 measures covering at least 2 of the NQS domains using the qualified registry, direct EHR product, EHR data submission vendor, or GPRO web interface reporting mechanisms Tables 49 and 50 provide a summary of our final crit eria for the satisfactory reporting of data on PQRS quality measures via the GPRO for the 2014 PQ RS incentive and 2016 PQRS payment adjustment. Please note that we are adding paragraph §414.90(h)(5 ) to specify the criteria for the satisfactory reporting of data on PQRS quality measures via the GPRO for the 2014 PQRS incentive as described in Table 49, and we are adding paragraph §414.90(j)(5) to specify the criteria for the satisfactory reporting

### CMS-1600-FC 821

of data on PQRS quality measures via the GPRO for the 2016 PQRS payment adjustment as described in

Table 50. TABLE 49: Summary of Final Requirements for the 2014 PQRS Incentive: Criteria for Satisfactory Reporting of Data on PQRS Quality Measures via the GPRO Reporting Period Reporting Mechanism Group Practice Size Proposed Reporting Criterion

** 12-month (Jan 1 — Dec 31) GPRO Web interface 25-99 eligible professiona ls Report on all measures includ ed in the web interface; AND Populate data fields for the firs t 218 consecutively ranked and assigned beneficiaries in the order in which they appear in the group’s sample for each module or preventive care measure. If the pool of eligible assigned beneficiaries is less than 218, then report on 100 percent of assigned beneficiaries.

** 12-month (Jan 1 — Dec 31) GPRO Web interface 100+ eligible professiona ls Report on all measures includ ed in the web interface; AND Populate data fields for the firs t 411 consecutively ranked and assigned beneficiaries in the order in which they appear in the group’s sample for each module or preventive care measure. If the pool of eligible assigned beneficiaries is less than 411, then report on 100 percent of assigned beneficiaries. In addition, the group practice must also report all CG CAHPS survey measures via ce rtified survey vendor.

12-month (Jan 1 — Dec 31) Qualified Registry 2 + eligible professiona ls Report at least 9 measures covering at least 3 of the NQS domains, OR, if less than 9 measures covering at least 3 NQS domains apply to the group practice, report 1— 8 measures covering 1-3 NQS domains for which there is Medicare patient data, AND report each measure for at least 50 percent of the group practice’s Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent performance rate would not be counted. For a group practice who reports fewe r than 9 measures covering at least 3 NQS domains via the regist ry-based reporting mechanism, the group practice will be subject to the MAV process, which would allow us to determine whether a group practice should have reported on additional measures and/or measures covering additional NQS domains.

** 12-month (Jan 1 — Dec 31) Direct EHR product that is CEHRT/ EHR data submission vendor that is CEHRT 2+ eligible professiona ls Report 9 measures covering at l east 3 of the NQS domains. If a group practice's CEHRT does not cont ain patient data for at least 9 measures covering at least 3 domai ns, then the group practice must report the measures for which there is Medicare patient data. A group practice must report on at least 1 measure for which there is Medicare patient data.

### CMS-1600-FC 822

12-month (Jan 1 — Dec 31 CMS-certified survey vendor + qualified registry, direct EHR product, EHR data submission vendor, or GPRO web interface 25+ eligible professiona ls Report all CG CAHPS survey meas ures via a CMS-certified survey vendor, AND report at least 6 meas ures covering at least 2 of the NQS domains using a qualified registry, direct EHR product, EHR data submission vendor, or GPRO web interface.

*Subject to the Measure Application Validity (MAV) process. ** Criteria finalized in the CY 2013 PFS final rule (77 FR 69200). TABLE 50: Summary of Final Requirements for the 2016 PQRS Payment Adjustment: Criteria for Satisfactory Reporting of Data on PQRS Quality Measures via the GPRO Reporting Period Reporting Mechanism Group Practice Size Proposed Reporting Criterion

** 12-month (Jan 1 — Dec 31) GPRO Web interface 25-99 eligible professiona ls Report on all measures includ ed in the web interface; AND Populate data fields for the firs t 218 consecutively ranked and assigned beneficiaries in the order in which they appear in the group’s sample for each module or preventive care measure. If the pool of eligible assigned beneficiaries is less than 218, then report on 100 percent of assigned beneficiaries.

** 12-month (Jan 1 — Dec 31) GPRO Web interface 100+ eligible professiona ls Report on all measures includ ed in the web interface; AND Populate data fields for the firs t 411 consecutively ranked and assigned beneficiaries in the order in which they appear in the group’s sample for each module or preventive care measure. If the pool of eligible assigned beneficiaries is less than 411, then report on 100 percent of assigned beneficiaries. In addition, the group practice must report all CG CAHPS survey measures via certified survey vendor.

12-month (Jan 1 — Dec 31) Qualified Registry 2 + eligible professiona ls Report at least 9 measures covering at least 3 of the NQS domains, OR, if less than 9 measures covering at least 3 NQS domains apply to the group practice, report 1— 8 measures covering 1-3 NQS domains for which there is Medicare patient data, AND report each measure for at least 50 percent of the group practice’s Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent performance rate would not be counted. For a group practice who reports fewer than 9 measures via the registry-based reporting mechanis m, the group practice would be subject to the MAV process, whic h would allow us to determine whether a group practice should have reported on additional measures and/or measures covering additional NQS domains.

### CMS-1600-FC 823

12-month (Jan 1 — Dec 31) Qualified Registry 2 + eligible professiona ls Report at least 3 measures covering at least 1 of the NQS domains, OR, if less than 3 measures covering 1 NQS domain apply to the group practice, report 1—2 measures covering 1 NQS domain for which there is Medicare patient data, AND report each measure for at least 50 percent of the gr oup practice’s Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a 0 percent performance rate would not be counted. For a group practice who reports fe wer than 3 measures covering 1 NQS domain via the registry-based reporting mechanism, the group practice would be subject to the MAV process, which would allow us to determine whether a group practice should have reported on additional measures.

** 12-month (Jan 1 — Dec 31) Direct EHR product that is CEHRT/ EHR data submission vendor that is CEHRT 2+ eligible professiona ls Report 9 measures covering at l east 3 of the NQS domains. If a group practice's CEHRT does not cont ain patient data for at least 9 measures covering at least 3 domai ns, then the group practice must report the measures for which there is Medicare patient data. A group practice must report on at least 1 measure for which there is Medicare patient data.

12-month (Jan 1 — Dec 31 CMS-certified survey vendor + qualified registry, direct EHR product, EHR data submission vendor, or GPRO web interface 25+ eligible professiona ls Report all CG CAHPS survey meas ures via a CMS-certified survey vendor, AND report at least 6 meas ures covering at least 2 of the NQS domains using a qualified registry, direct EHR product, EHR data submission vendor, or GPRO web interface.

*Subject to the Measure Application Validity (MAV) process. ** Criteria finalized in the CY 2013 PFS final rule (77 FR 69200). 9. Statutory Requirements and Ot her Considerations for the Selection of PQRS Quality Measures for Meeting the Criteria for Satisfactory Reporting for 20 14 and Beyond for Individual Eligible Professionals and Group Practices

CMS underwent an annual Call for Measures that solicited new measures from the public for possible inclusion in the PQRS for 2014 and beyond. During the Call for Measures, we requested measures for inclusion in PQRS that meet the following statutory and non-statutory criteria.

### CMS-1600-FC 824

Sections 1848(k)(2)(C) and 1848(m)(3)(C)(i) of the Act, respectively, govern the quality measures reported by individual eligible professiona ls and group practices re porting under the PQRS. Under section 1848(k)(2)(C)(i) of the Act, the PQRS qua lity measures shall be such measures selected by the Secretary from measures that have been endorsed by the entity with a contract with the Secretary under section 1890(a) of the Act (currently, that is the National Quality Forum, or NQF). However, in the case of a specified area or medical topic determined a ppropriate by the Secretary for which a feasible and practical measure has not been endorsed by the NQF , section 1848(k)(2)(C)(ii) of the Act authorizes the Secretary to specify a measure that is not so endorsed as long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary, such as the AQA alliance. In light of these statutory requireme nts, we believe that, except in the circumstances specified in the statute, each PQRS quality measure must be endorsed by the NQF. Additionally, section 1848(k)(2)(D) of the Act requires that for each PQRS qua lity measure, "the Secretary shall ensure that eligible professionals have the opportunity to pr ovide input during the development, endorsement, or selection of measures applicable to services they furnish." The statutory requirements under section 1848(k)(2)(C) of the Act, subject to the exception noted previously, require only that the measures be select ed from measures that have been endorsed by the entity with a contract with the Secretary under section 1890(a) of the Act (that is, the NQF) and are silent

for how the measures that are submitte d to the NQF for endorsement were developed. The basic steps for developing measures applicable to physicians and other eligible prof essionals prior to submission of the measures for endorsement may be carried out by a vari ety of different organiza tions. We do not believe there needs to be any special restrictions on the type or make-up of the organizations carrying out this basic process of development of physician measures, such as restricting the initial development to physician-controlled organizations. Any such rest riction would unduly limit the basic development of quality measures and the scope and utility of measur es that may be considered for endorsement as voluntary consensus standards for purposes of the PQRS.

### CMS-1600-FC 825

In addition to section 1848(k)(2)(C) of the Act, section 1890A of the Act, which was added by section 3014(b) of the Affordable Care Act, requires th at the entity with a contract with the Secretary under section 1890(a) of the Act (currently, that is the NQF) convene multi-stakeholder groups to provide input to the Secretary on the selection of cer tain categories of quality and efficiency measures. These categories are described in section 1890(b)(7)(B ) of the Act, and include such measures as the quality measures selected for reporting under the PQRS. Under section 3014 of the Affordable Care Act, the NQF convened multi-stakeholder groups by creating the Measure Applications Partnership (MAP). Section 1890(A)(a) of the Act requires that the Secr etary establish a pre-rulemaking process in which the Secretary must make publicly available by December 1 st of each year a list of the quality and efficiency measures that the Secretary is considering for selection through rulemaking for use in the Medicare program. The NQF must provide CMS with the MAP’s input on selecting measures by February 1 st of each year. The list of measures under c onsideration for 2013 is available at http://www.qualityforum.org/map/

. As we noted above, section 1848(k)(2)(C)(ii) of the Act provides an exception to the requirement that the Secretary select measures that have been endorsed by the entity with a contract under section 1890(a) of the Act (that is, the NQF). We may select measures under this exception if there is a specified area or medical topic for which a feasible and practical measure has not been endorsed by the entity, as long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary. We requested that stakeholders apply the following

considerations when submitti ng measures for possible inclusion in the PQRS measure set:

● High impact on healthcare.

● Measures that are high impact and support CMS and HHS priorities for improved quality and efficiency of care for Medicare beneficiaries.

● Measures that address gaps in the quality of care delivered to Medicare beneficiaries.

● Address Gaps in the PQRS measure set.

### CMS-1600-FC 826

● Measures impacting chronic conditions (chronic kidney disease, diabetes mellitus, heart failure, hypertension and musculoskeletal).

● Measures applicable across care settings (suc h as, outpatient, nursing facilities, domiciliary, etc.).

● Broadly applicable measures that could be u sed to create a core measure set required of all participating eligible professionals.

● Measures groups that reflect the services furnished to beneficiaries by a particular specialty. 10. PQRS Quality Measures Taking into consideration the statutory and non-st atutory criteria we described previously, this section contains our proposals for the inclusion or removal of measures in PQRS for 2014 and beyond. We are classifying all measures against six domains based on the NQS’s six priorities, as follows: (1) Person and Caregiver-Cen tered Experience and Outcomes

. These are measures that reflect the potential to improve patient-centered care and th e quality of care delivered to patients. They emphasize the importance of collecting patient-repor ted data and the ability to impact care at the individual patient level, as well as the population le vel through greater involvement of patients and families in decision making, self-care, activation, and understanding of their health condition and its effective management. (2) Patient Safety

. These are measures that reflect the safe delivery of clinical services in both hospital and ambulatory settings and include processes that would reduce harm to patients and reduce burden of illness. These measures should enable long itudinal assessment of condition-specific, patientfocused episodes of care. (3) Communication and Care Coordination

. These are measures that demonstrate appropriate and timely sharing of information and coordination of clinical and preventive services among health professionals in the care team and with patients, car egivers, and families to improve appropriate and timely patient and care team communication.

### CMS-1600-FC 827

(4) Community/Population Health

. These are measures that reflect the use of clinical and preventive services and achieve improvements in the h ealth of the population served. These are outcomefocused and have the ability to achieve longitudinal measurement that will dem onstrate improvement or lack of improvement in the health of the US population. (5) Efficiency and Cost Reduction

. These are measures that reflect efforts to significantly improve outcomes and reduce errors. These measures al so impact and benefit a large number of patients and emphasize the use of evidence to best manage hi gh priority conditions and determine appropriate use

of healthcare resources. (6) Effective Clinical Care

. These are measures that reflect clin ical care processes closely linked to outcomes based on evidence and practice guidelines. Please note that the PQRS quality measure specifi cations for any given PQRS quality measure may differ from specifications for the same quality meas ure used in prior years. For example, for the PQRS quality measures that were selected for repor ting in 2013 and beyond, please note that detailed measure specifications, including the measure’s title , for the individual PQRS quality measures for 2013 and beyond may have been updated or modified during the NQF endorsement process or for other reasons. In addition, due to our desire to align me asure titles with the measure titles that are finalized for 2013, 2014, 2015, and potentially subsequent years of the EHR Incentive Program, we note that the measure titles for measures available for reporting via EH Rs may change from year to year. We note that the EHR Incentive Program has updated its measure titl es to include version numbers, and these version numbers are referenced in the tables containing the final PQRS measures set below. Please note that any changes reflected below are not substantive. We will continue to work toward complete alignment, where possible, of measure specifications across program s, and do so in both rulemaking and subregulatory communication, as applicable, including through guidance such as in the detailed quality measure specifications PQRS publishes each year at http://www.cms.gov/Medicare/Quality-Initiatives-PatientAssessment-Instruments/PQRS/index.html

.

### CMS-1600-FC 828

Through NQF’s measure maintenance process, NQF endorsed measures are sometimes updated to incorporate changes that we believe do not substant ively change the nature of the measure. Examples of such changes could be updated diagnosis or proce dure codes or changes to exclusions to the patient population or definitions. We believe these types of maintenance changes are distinct from more substantive changes to measures that result in what are considered new or different measures, and that they do not trigger the same agency obligations unde r the Administrative Procedure Act. In the CY 2013 PFS final rule with comment period, we finalized our proposal providing that if the NQF updates an endorsed measure that we have adopted for the PQRS in a manner that we consider to not substantively change the nature of the measure, we would use a subregulatory process to incorporate those updates to the measure specifications that apply to the program (77 FR 69207). We believe this adequately balances our need to incorporate non-substantive NQF updates to NQF-endorsed measures in the most expeditious manner possible, while preserving the public’s abilit y to comment on updates that so fundamentally change an endorsed measure that it is no longer the same measure that we originally adopted. We also noted that the NQF process incorporates an opportuni ty for public comment and engagement in the measure maintenance process. We will revise th e Specifications Manual and post notices to clearly identify the updates and provide links to where a dditional information on the updates can be found. Updates will also be available on the CMS PQRS website at http://www.cms.gov/Medicare/QualityInitiatives-Patient-Assessment-Instruments/PQRS/index.html

. Additionally, eligible professionals and registry vendors should be aware that the 2014 Physician Quality Reporting System (PQRS) Claims /Registry Measure Specifications Manual and other supporting documentation may be published w ith placeholder quality- data codes (represented as GXXXX ) in a subset of measures’ numerator options. PQRS particip ants should note that these placeholder codes should

not be submitted and will not count toward satisfact ory reporting. In the event the specifications are published with the placeholder codes, we will revise th e measure specifications and post notices to clearly identify the updates and provide links to where a dditional information on the updates can be found.

### CMS-1600-FC 829

Updates will also be available on the CMS PQRS website at http://www.cms.gov/Medicare/QualityInitiatives-Patient-Assessment-Instruments/PQRS/index.html

. For the PQRS EHR measures that are also repor table under the EHR Incentive Program (that is, electronically specified clinical quality measures), please note that the updates to these measures will be provided on the EHR Incentive Program website. We understand that the EHR Incentive Program may accept versions of electronically specified clinical quality measures that may be outdated. We proposed that for purposes of the PQRS, eligible professionals must report the most recent, updated version of a clinical quality measure (78 FR 43371). We solicited and received no public comment on this proposal. However, we are not finalizing this proposal. To a void confusion on which measu re version to report for the PQRS, rather than redirecting eligible professi onals to the EHR Incentive Program website, although actual measure specifications will be provided on the EHR Incentive Program website, the electronic measure version that must be reported under the PQRS for a specific year will be found in the Measure Specifications List updated for that year. For exam ple, for purposes of reporting clinical quality measures that are electronically specified during the PQRS reporting periods that occur in 2014, we would only accept the version of clinical quality measures that wi ll be found in the 2014 Measure Specifications List, which will be made available at the PQRS website at http://www.cms.gov/Medicare/Quality-InitiativesPatient-Assessment-Instruments/PQRS/index.html . However, please note that the 2014 PQRS Measures List will to the EHR Incentive Program’s website for the measure specifications for the 2014 EHR

measures. We also understand, for purposes of the EHR Incentive Program, that once direct EHR products

and EHR data submission vendors are issued a 2014 Ed ition certification for clinical quality measures, they will not necessarily be required to have such technology retested and recertified against the most recent, updated version of a clinical quality measure when such versions are made available. We proposed that for purposes of PQRS, however, that th e eligible professional’s direct EHR product or EHR

data submission vendor must be tested and certified to the most updated, recent versions of electronically specified clinical quality measures for that year (78 FR 43371-43372). We solicited but received no

### CMS-1600-FC 830

public comment on this proposal to require eligible professionals to use a direct EHR product or EHR

data submission vendor that has been tested and certified to the most recent, updated version of the clinical quality measure’s electronic specifications for PQRS purposes. However, we are not finalizing this proposal. Instead, for purposes of PQRS, the e ligible professional’s direct EHR product or EHR data

submission vendor must be tested and certified to the versions of electronically specified clinical quality measures listed in the Measure Specifications List fo r the particular program year. For example, for purposes of reporting clinical quality measures that ar e electronically specified during the PQRS reporting periods that occur in 2014, we would only accept th e reporting of clinical quality measures from direct EHR products or EHR data submissi on vendors that have been tested and certified to versions of the electronic specifications that will be found in the 2014 PQRS Measure Specifications List that will be released following the display of this final rule with comment period. Since the PQRS Measure Specifications List is not typically released until late November/December of the y ear prior to the January 1 start of the reporting periods for a particularly y ear, we understand that vendors may be concerned with having enough time to update their systems with the most recent measure specifications in time prior to the start of the year. Please note that, unless there are errors discovered in updated electronic measure specifications, the PQRS intends to use the most r ecent, updated versions of electronically specified clinical quality measures for that year. For exam ple, for 2014, the PQRS will accept the June 2013 versions of electronically specified clinical quality measures under the EH R Incentive Program, except for the following measure – CMS140v2, Breast Canc er Hormonal Therapy for Stage IC-IIIC Estrogen Receptor/Progesterone Receptor (ER/ PR) Positive Breast Cancer (NQF 0387). As a substantive error which would result in a, erroneous zero percent performance rate when reported this measure was

discovered in the June 2013 version of this electr onically specified clinical quality measure, the PQRS will require the use of the prior, December 2012 version of this measure, which is CMS140v1. a. Individual PQRS Measures and Measures within Measures Groups Available for Reporting for 2014 and Beyond (1) PQRS Core Measures Available for Reporting for 2014 and Beyond

### CMS-1600-FC 831

In the CY 2013 PFS final rule with comment period, we finalized the HHS Million Hearts

Measures as a recommended set of core measures for wh ich we encourage eligible professionals to report in PQRS (77 FR 69209). In addition to the HHS M illion Hearts Measures we previously finalized, we proposed to include the measures specified in the EHR Incentive Program as additional recommended core measures for 2014 and beyond (78 FR 43372- 43378, Table 28). These additional proposed

recommended core measures were also finalized as recommended core measures in the EHR Incentive Program for 2014. Therefore, due to our desire to align with the recommended measures available under the EHR Incentive Program, we proposed the additio nal recommended measures specified in Table 51 for 2014 and beyond. We solicited and received th e following public comment on this proposal:

Comment : Several commenters generally supported our proposal to align, when possible, the clinical quality measures found under the PQRS and the clinical quality measures found under the EHR Incentive Program. Response : We appreciate the commenters’ general support in aligning measures under the PQRS and the EHR Incentive Program. In response to the co mment and for the reasons we discussed above, we are finalizing our proposal to add these measure s as recommended core measures under the PQRS for 2014 and beyond. Table 51 shows the final measu res classified as the PQRS recommended core measures for 2014 and beyond.CMS-1600-FC 832TABLE 51: Physician Quality Reporting System Recommended Core Measures for 2014 and Beyond

NQF/ PQRS CMS E-Measure IDNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs0002/66**146v2 Efficiency and CostReductionAppropriate Testing for Children withPharyngitis:Percentage of children 2-18 years of agewho were diagnosed with pharyngitis, ordered anantibiotic and received agroup A streptococcus(strep) test for the episodeNCQA X X MU20018/236*165v2 Effective Clinical CareControlling High Blood Pressure:Percentage ofpatients 18-85 years of age who had a diagnosis ofhypertension and whose blood pressure wasadequately controlled (<140/90 mmHg) during themeasurement period.NCQA X X X X X MU2ACOMillionHearts0022/238*156v2 Patient SafetyUse of High-Risk Medications in the Elderly:Percentage of patients 66 years of age and older whowere ordered high-risk medications. Two rates arereported.a. Percentage of patients who were ordered at leastone high-risk medication.b. Percentage of patients who were ordered at leasttwo different high-risk medications.NCQA X MU2CMS-1600-FC 833

NQF/ PQRS CMS E-Measure IDNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs0024/239**155v2 Community/PopulationHealthWeight Assessment and Counseling for Nutritionand Physical Activity for Children andAdolescents:Percentage of patients 3-17 years of agewho had an outpatient visit with a Primary CarePhysician (PCP) or Obstetrician/Gynecologist(OB/GYN) and who had evidence of the followingduring the measurement period. Three rates arereported.- Percentage of patients with height, weight, and bodymass index (BMI) percentile documentation- Percentage of patients with counseling for nutrition- Percentage of patients with counseling for physicalactivityNCQA X MU20028/226*138v2 Community/PopulationHealthPreventive Care and Screening: Tobacco Use:Screening and Cessation Intervention:Percentageof patients 18 years and older who were screened fortobacco use one or more times within 24 monthsANDwho received cessation counseling intervention ifidentified as a tobacco userAMAPCPIX X X X X MU2ACOMillionHearts0033/310**153v2 Community/Population HealthChlamydia Screening for Women:Percentage ofwomen 16-24 years of age who were identified assexually active and who had at least one test forchlamydia during the measurement periodNCQA X MU20036/311**126v2 Effective Clinical CareUse of Appropriate Medications for Asthma:Percentage of patients 5-64 years of age who wereidentified as having persistent asthma and wereappropriately prescribedmedication during themeasurement periodNCQA X MU2CMS-1600-FC 834

NQF/ PQRS CMS E-Measure IDNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs0038/240**117v2 Community/PopulationHealthChildhood Immunization Status:Percentage ofchildren 2 years of age who had four diphtheria,tetanus and acellular pertussis (DTaP); three polio(IPV), one measles, mumps and rubella (MMR); threeH influenza type B (HiB); three hepatitis B (Hep B);one chicken pox (VZV); four pneumococcal conjugate(PCV); one hepatitis A (Hep A); two or threerotavirus (RV); and two influenza (flu) vaccines bytheir second birthdayNCQA X MU20052/312*166v3 Efficiency and CostReductionUse of Imaging Studies for Low Back Pain:Percentage of patients 18-50 years of age with adiagnosis of low back pain who did not have animaging study (plain X-ray, MRI, CT scan) within 28days of the diagnosis.NCQA X MU20069/65**154v2 Efficiency and CostReductionAppropriate Treatment for Children with UpperRespiratory Infection (URI):Percentage of children3 months-18 years of age who were diagnosed withupper respiratory infection (URI) and were notdispensed an antibiotic prescription on or three daysafter the episodeNCQA X X MU2CMS-1600-FC 835

NQF/ PQRS CMS E-Measure IDNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs0108/N/A**136v3 Effective Clinical CareADHD: Follow-Up Care for Children PrescribedAttention-Deficit/Hyperactivity Disorder (ADHD)Medication:Percentage of children 6-12 years of ageand newly dispensed a medication for attentiondeficit/hyperactivity disorder (ADHD) who hadappropriate follow-up care. Two rates are reported.a. Percentage of children who had one follow-up visitwith a practitioner with prescribing authority duringthe 30-Day Initiation Phase.b. Percentage of children who remained on ADHDmedication for at least 210 days and who, in additionto the visit in the Initiation Phase, had at least twoadditional follow-up visits with a practitioner within270 days (9 months) after the Initiation Phase ended.NCQA X MU20418/134***2v3 Community/PopulationHealthPreventive Care and Screening: Screening forClinical Depression and Follow-Up Plan:Percentage of patients aged 12 years and olderscreened for clinical depression on the date of theencounter using an age appropriate standardizeddepression screening tool AND if positive, a followup plan is documented on the date of the positivescreen.CMS X X X X MU2ACOCMS-1600-FC 836

NQF/ PQRS CMS E-Measure IDNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs0419/130*68v3 Patient SafetyDocumentation of Current Medications in theMedical Record:Percentage of visits for patientsaged 18 years and olderfor which the eligibleprofessional attests to documenting a list of currentmedications using all immediate resources availableon the date of the encounter. This listmustincludeALL known prescriptions, over-the-counters, herbals,and vitamin/mineral/dietary (nutritional) supplementsANDmustcontain the medications’ name, dosage,frequency and route of administration.CMS X X X X MU20421/128*69v2 Community/PopulationHealthPreventive Care and Screening: Body Mass Index(BMI) Screening and Follow-Up:Percentage ofpatients aged 18 years andolder with a documentedBMI during the current encounter or during theprevious 6 months AND when the BMI isoutside ofnormal parameters, a follow-up plan is documentedduring the encounter or during the previous 6 monthsof the encounterNormal Parameters:Age 65 years and older BMI≥23 and < 30; Age 18 – 64 years BMI≥18.5 and < 25CMS X X X X X MU2ACON/A/N/A**75v2 Effective Clinical CareChildren Who Have Dental Decay or Cavities:Percentage of children, age 0-20 years, who have hadtooth decay or cavities during the measurement periodCMS X MU2N/A/N/A*50v2 Communication and CareCoordinationClosing the referral loop: receipt of specialistreport:Percentage of patients with referrals,regardless of age, for which the referring providerreceives a report from theprovider to whom thepatient was referredCMS X MU2CMS-1600-FC 837

NQF/ PQRS CMS E-Measure IDNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsN/A/N/A*90v3 Person and CaregiverCentered Experience andOutcomesFunctional Status Assessment for ComplexChronic Conditions:Percentage of patients aged 65years and older with heart failure who completedinitial and follow-up patient-reported functional statusassessmentsCMS X MU2* Recommended Adult Core CQMs for eligible professionals** Recommended Pediatric Core CQMs for eligible professionals¥ Titles and descriptions in this table are aligned with the 2014Physician Quality Reporting System Claims and Qualified Registry measure titles anddescriptions, and may differ based on reporting mechanism withinPQRS. Additionally, there may be tittle and description variations for the same measure acrossother quality reporting programs. Please reference the NationalQuality Forum (NQF) and Physician Quality Reporting System numbers for clarification.

### CMS-1600-FC 838

(2) Individual PQRS Measures Available for Reporting for 2014 and Beyond In the CY 2014 PFS proposed rule, we proposed to include additional measures in the PQRS measure set for 2014 and beyond (see Table 52, 78 FR 43379). We solicited and received public comment on these proposed measures. Table 52 provides the individual quality measur es and measures included in the PQRS measures groups we are finalizing for 2014 and beyond. The comments received a nd our responses to these

comments are also contained in Table 52. Please not e that Table 52 also provides certain measures we previously finalized for 2013 or 2014 and beyond in the CY 2013 PFS final rule with comment period ( see Table 95, 77 FR 69215). Please also note that, in th e CY 2014 proposed rule, in an effort t to move away from claims-based process measures, we proposed to change the reporting mechanisms for which certain measures were previously reportable (78 FR 43474). Please note that the comments we received on these proposed reporting mechanism changes, as well as our responses are also specified in Table 52. Furthermore, CMS recognizes that updated clinical guidelines for cholesterol screening were recently released. The measures related to cholester ol screening contained in Table 52 do not reflect these recently updated guidelines. CMS will work to address any potential changes related to these new guidelines in future rulemakingCMS-1600-FC 839TABLE 52: Final Individual Quality Measures and Those Included inMeasures Groups for the Physician Quality Reporting System tobeAvailable for Satisfactory Reporting via Claims, Registry, or EHR Beginning in 2014

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs0059/1122v2 Effective Clinical CareDiabetes: Hemoglobin A1c PoorControl:Percentage of patients 18-75years of age with diabetes who hadhemoglobin A1c > 9.0% during themeasurement period.This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).NCQA X X X X X MU2ACO0064/2163v2 Effective Clinical CareDiabetes: Low Density Lipoprotein(LDL) Management:Percentage ofpatients 18–75 years of age withdiabetes whose LDL-C was adequatelycontrolled (<100 mg/dL) during themeasurement period.This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).NCQA X X X X MU2MillionHearts0081/5135v2 Effective Clinical CareHeart Failure (HF): AngiotensinConverting Enzyme (ACE) Inhibitoror Angiotensin Receptor BlockerAMAPCPI/ACCF/AHAX X X MU2CMS-1600-FC 840

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs(ARB) Therapy for Left VentricularSystolic Dysfunction (LVSD):Percentage of patients aged 18 yearsand older with a diagnosis of heartfailure (HF) with a current or prior leftventricular ejection fraction (LVEF) <40% who were prescribed ACEinhibitor or ARB therapy either within a12 month period when seen in theoutpatient setting OR ateachhospitaldischargeThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0067/6Effective Clinical CareCoronary Artery Disease (CAD):Antiplatelet Therapy:Percentage ofpatients aged 18 years and older with adiagnosis of coronary artery diseaseseen within a 12 month period whowere prescribed aspirin or clopidogrel*The EHR-based reporting mechanismis no longer available for reporting thismeasure for 2014 and beyond.*AMAPCPI/ACCF/AHAX X XCMS-1600-FC 841

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsWe solicited but received no publiccomment on this proposed measure. Inan effort to align with the EHRIncentive Program, this measure will nolonger be reportable via EHR beginningin 2014. The alignment of measurescontained within multiple CMSreporting programs eases the burden ofreporting and encourages eligibleprofessionals to submit quality clinicaldata on care provided for Medicarebeneficiaries. Alignment also promotesa robust data source and consistency inanalysis, which supports other qualityprograms within CMS. For the reasonspreviously stated, we are finalizing theremoval of the EHR-based optionbeginning in 2014.0070/7145v2 Effective Clinical CareCoronary Artery Disease (CAD):Beta-Blocker Therapy – PriorMyocardial Infarction (MI) or LeftVentricular Systolic Dysfunction(LVEF < 40%):Percentage of patientsaged 18 years and older with adiagnosis of coronary artery diseaseAMA- PCPI/ACCF/AHAX X MU2CMS-1600-FC 842

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsseen within a 12 month period who alsohave prior MI OR a current or LVEF <40% who were prescribed beta-blockertherapyThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0083/8144v2 Effective Clinical CareHeart Failure (HF): Beta-BlockerTherapy for Left Ventricular SystolicDysfunction (LVSD):Percentage ofpatients aged 18 years and older with adiagnosis of heart failure (HF) with acurrent or prior left ventricular ejectionfraction (LVEF) < 40% who wereprescribed beta-blocker therapy eitherwithin a 12 month period when seen inthe outpatient setting OR ateachhospital dischargeThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/ACCF/AHAX X X X MU2ACO0105/ 128v2 Effective Clinical CareAnti-depressant MedicationManagement:Percentage of patients 18NCQA X X MU2CMS-1600-FC 843

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs9years of age and older who were diagnosedwith major depression and treated withantidepressant medication, and whoremained on antidepressant medicationtreatment. Two rates are reporteda.Percentage of patients whoremained on an antidepressantmedication for at least 84 days (12weeks).b.Percentage of patients whoremained on an antidepressantmedication for at least 180 days (6months).*The claims-based reporting option isno longer available for reporting thismeasure for 2014 and beyond,additionally, the EHR-based reportingoption is available for reporting thismeasure beginning in 2014.*Several commenters were concernedwith CMS’ proposal to eliminate theclaims-based reporting option for thismeasure, stating eligible professionalswho may have reported this measurewill no longer be able to participate inPQRS. CMS appreciates thecommenters’ concerns but notes thatthis measure will still be available forregistry-based reporting, along withCMS-1600-FC 844

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsadditional clinically-related measures.Eligible professionals who report thismeasure will still have an opportunityto participate in PQRS using theregistry-based reporting option. Asstated in the proposed rule, 2012 claimsdata indicates a low threshold ofeligible professionals reporting thismeasure via claims.CMS intends tostreamline the reporting optionsavailable under the PQRS and toeliminate reporting options that are notwidely used.Additionally, in an effort to align withthe EHR Incentive Program, thismeasure will be reportable via EHRbeginning in 2014. The alignment ofmeasures contained within multipleCMS reporting programs eases theburden of reporting and encourageseligible professionals to submit qualityclinical data on care provided forMedicare beneficiaries. Alignment alsopromotes a robust data source andconsistency in analysis, which supportsother quality programs within CMS.For the reasons previously stated, weare finalizing the removal of the claimsbased option and the addition of theEHR-based reporting option for thismeasure beginning in 2014.0086/ 143v2 Effective Clinical CarePrimary Open-Angle GlaucomaAMA- PCPI/ X X X MU2CMS-1600-FC 845

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs12(POAG): Optic Nerve Evaluation:Percentage of patients aged 18 yearsand older with a diagnosis of primaryopen-angle glaucoma (POAG) whohave an optic nerve head evaluationduring one or more office visits within12 monthsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).NCQA0087/14Effective Clinical CareAge-Related Macular Degeneration(AMD): Dilated MacularExamination:Percentage of patientsaged 50 years and older with adiagnosis of age-related maculardegeneration (AMD)who had a dilatedmacular examination performed whichincluded documentation of the presenceor absence of macular thickening orhemorrhage AND the level of maculardegeneration severity during one ormore office visits within 12 monthsThis measure was finalized forAMA- PCPI/NCQAX XCMS-1600-FC 846

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0088/18167v2 Effective Clinical CareDiabetic Retinopathy:Documentation of Presence orAbsence of Macular Edema andLevel of Severity of Retinopathy:Percentage of patients aged 18 yearsand older with a diagnosis of diabeticretinopathy who had a dilated macularor fundus exam performed whichincluded documentation of the level ofseverity of retinopathy and the presenceor absence of macular edema duringone or more office visits within 12monthsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAX X X MU20089/19142v2 Effective Clinical CareDiabetic Retinopathy:Communication with the PhysicianManaging Ongoing Diabetes Care:Percentage of patients aged 18 yearsand older with a diagnosis of diabeticAMA- PCPI/NCQAX X X MU2CMS-1600-FC 847

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsretinopathy who had a dilated macularor fundus exam performed withdocumented communication to thephysician who manages the ongoingcare of the patient with diabetesmellitus regarding the findings of themacular or fundus exam at least oncewithin 12 monthsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).However, please note that we areupdating the domain for this measurefrom the Communication CareCoordination domain. We are makingthis change to align with the domainsindicated in the EHR Incentive Programfinal rule for 2014. It is necessary forthe domains for EHR measures withinthe EHR Incentive Program and thePQRS to create consistency for theEHR systems used to report thesemeasures have one set of logic.CMS-1600-FC 848

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs0270/20Patient SafetyPerioperative Care: Timing ofProphylactic Parenteral Antibiotic –Ordering Physician:Percentage ofsurgical patients aged 18 years andolder undergoing procedures with theindications for prophylactic parenteralantibiotics, who have an order forprophylactic parenteral antibiotic to begiven within one hour (iffluoroquinolone or vancomycin, twohours), prior to the surgical incision (orstart of procedure when no incision isrequired)This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAX X X0268/21Patient SafetyPerioperative Care: Selection ofProphylactic Antibiotic – First ORSecond Generation Cephalosporin:Percentage of surgical patients aged 18years and older undergoing procedureswith the indications for a first ORsecond generation cephalosporinprophylactic antibiotic, who had anAMA- PCPI/NCQAX X XCMS-1600-FC 849

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsorder for a first OR second generationcephalosporin for antimicrobialprophylaxisThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0271/22Patient SafetyPerioperative Care: Discontinuationof Prophylactic ParenteralAntibiotics (Non-CardiacProcedures):Percentage of noncardiac surgical patients aged 18 yearsand older undergoing procedures withthe indications for prophylacticparenteral antibiotics AND whoreceived a prophylactic parenteralantibiotic, who have an order fordiscontinuation of prophylacticparenteral antibiotics within 24 hours ofsurgical end timeThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAX X XCMS-1600-FC 850

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs0239/23Patient SafetyPerioperative Care: VenousThromboembolism (VTE)Prophylaxis (When Indicated in ALLPatients):Percentage of surgicalpatients aged 18 years and olderundergoing procedures for which VTEprophylaxis is indicated in all patients,who had an order for Low MolecularWeight Heparin (LMWH), Low-DoseUnfractionated Heparin (LDUH),adjusted-dose warfarin, fondaparinux ormechanical prophylaxis to be givenwithin 24 hours prior to incision time orwithin 24 hours after surgery end timeThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAX X X0045/24Communication andCare CoordinationOsteoporosis: Communication withthe Physician Managing On-goingCare Post-Fracture of Hip, Spine orDistal Radius for Men and WomenAged 50 Years and Older:Percentageof patients aged 50 years and oldertreated for a hip, spine or distal radialAMA- PCPI/NCQAX XCMS-1600-FC 851

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsfracture with documentation ofcommunication with the physicianmanaging the patient’s on-going carethat a fracture occurred and that thepatient was or should be tested ortreated for osteoporosisThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0092/28Effective Clinical CareAspirin at Arrival for AcuteMyocardial Infarction (AMI):Percentage of patients, regardless ofage, with an emergency departmentdischarge diagnosis of acute myocardialinfarction (AMI) who haddocumentation of receiving aspirinwithin 24 hours before emergencydepartment arrival or during emergencydepartment stayThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAX XCMS-1600-FC 852

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs0269/30Patient SafetyPerioperative Care: Timing ofProphylactic Antiobiotic—Administering Physician:Percentageof surgical patients aged 18 years andolder who receive an anesthetic whenundergoing procedures with theindications for prophylactic parenteralantibiotics for whom administration ofa prophylactic parenteral antibioticordered has been initiated within onehour (if fluoroquinolone orvancomycin, two hours) prior to thesurgical incision (or start of procedurewhen no incision is required)This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAX X0240/31Effective Clinical CareStroke and Stroke Rehabilitation:Venous Thromboembolism (VTE)Prophylaxis for Ischemic Stroke orIntracranial Hemorrhage:Percentageof patients aged 18 years and older witha diagnosis of ischemic stroke orintracranial hemorrhage who wereAMA- PCPI/NCQAX XCMS-1600-FC 853

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsadministered venous thromboembolism(VTE) prophylaxis the day of or the dayafter hospital admissionThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0325/32Effective Clinical CareStroke and Stroke Rehabilitation:Discharged on AntithromboticTherapy:Percentage of patients aged18 years and older with a diagnosis ofischemic stroke or transient ischemicattack (TIA) who were prescribedantithrombotic therapy at dischargeThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAX X0241/33Effective Clinical CareStroke and Stroke Rehabilitation:Anticoagulant Therapy Prescribedfor Atrial Fibrillation (AF) atDischarge:Percentage of patients aged18 years and older with a diagnosis ofischemic stroke or transient ischemicAMA- PCPI/NCQAXCMS-1600-FC 854

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsattack (TIA) with documentedpermanent, persistent, or paroxysmalatrial fibrillation who were prescribedan anticoagulant at dischargeThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0243/35Effective Clinical CareStroke and Stroke Rehabilitation:Screening for Dysphagia:Percentageof patients aged 18 years and older witha diagnosis of ischemic stroke orintracranial hemorrhage who receiveany food, fluids or medication bymouth (PO) for whom a dysphagiascreening was performed prior to POintake in accordance with a dysphagiascreening tool approved by theinstitution in which the patient isreceiving careThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAX XCMS-1600-FC 855

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs0244/36Effective Clinical CareStroke and Stroke Rehabilitation:Rehabilitation Services Ordered:Percentage of patients aged 18 yearsand older with a diagnosis of ischemicstroke or intracranial hemorrhage forwhom occupational, physical, or speechrehabilitation services were ordered ator prior to inpatient discharge ORdocumentation that no rehabilitationservices are indicated at or prior toinpatient dischargeThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAX X0046/39Effective Clinical CareScreening or Therapy forOsteoporosis for Women Aged 65Years and Older:Percentage offemale patients aged 65 years and olderwho have a central dual-energy X- rayabsorptiometry (DXA) measurementordered or performed at least once sinceage 60 or pharmacologic therapyprescribed within 12 monthsAMA- PCPI/NCQAX X XCMS-1600-FC 856

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs*The EHR-based reporting mechanismis no longer available for reporting thismeasure for 2014 and beyond.*In an effort to align with the EHRIncentive Program, this measure will nolonger be reportable via EHR beginningin 2014. The alignment of measurescontained within multiple CMSreporting programs eases the burden ofreporting and encourages eligibleprofessionals to submit quality clinicaldata on care provided for Medicarebeneficiaries. Alignment also promotesa robust data source and consistency inanalysis, which supports other qualityprograms within CMS. For the reasonspreviously stated, we are finalizing theremoval of the EHR-based optionbeginning in 2014.0048/40Effective Clinical CareOsteoporosis: ManagementFollowing Fracture of Hip, Spine orDistal Radius for Men and WomenAged 50 Years and Older:Percentageof patientsaged 50 years and olderwith fracture of the hip, spine, or distalAMA- PCPI/NCQAX XCMS-1600-FC 857

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsradius who had a central dual-energy Xray absorptiometry (DXA)measurement ordered or performed orpharmacologic therapy prescribedThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0049/41Effective Clinical CareOsteoporosis: PharmacologicTherapy for Men and Women Aged50 Years and Older:Percentage ofpatientsaged 50 years and olderwitha diagnosis of osteoporosis who wereprescribed pharmacologic therapywithin 12 monthsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAX X0134/43Effective Clinical CareCoronary Artery Bypass Graft(CABG): Use of Internal MammaryArtery (IMA) in Patients withIsolated CABG Surgery:Percentageof patients aged 18 years and olderSTS X X XCMS-1600-FC 858

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsundergoing isolated CABG surgerywho received an IMA graftThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0236/44Effective Clinical CareCoronary Artery Bypass Graft(CABG): Preoperative Beta-Blockerin Patients with Isolated CABGSurgery:Percentage of isolatedCoronary Artery Bypass Graft (CABG)surgeries for patients aged 18 years andolder who received a beta-blockerwithin 24 hours prior to surgicalincisionThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).CMS X X X0637/45Patient SafetyPerioperative Care: Discontinuationof Prophylactic ParenteralAntibiotics (Cardiac Procedures):Percentage of cardiac surgical patientsaged 18 years and older undergoingAMA- PCPI/NCQAX XCMS-1600-FC 859

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsprocedures with the indications forprophylactic parenteral antibiotics ANDwho received a prophylactic parenteralantibiotic, who have an order fordiscontinuation of prophylacticparenteral antibiotics within 48 hours ofsurgical end timeThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0097/46Patient SafetyMedication Reconciliation:Percentage of patients aged 65 yearsand olderdischarged from any inpatient facility(e.g., hospital, skilled nursing facility,or rehabilitation facility) andseen within 30 days followingdischargein the office by thephysician, prescribing practitioner,registered nurse, or clinical pharmacistproviding on-going care who had areconciliation of the dischargemedications with the current medicationlist in the outpatient medical recordAMA- PCPI/NCQAX X X ACOCMS-1600-FC 860

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsdocumentedThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0326/47Communication andCare CoordinationAdvance Care Plan:Percentage ofpatients aged 65 years and older whohave an advance care plan or surrogatedecision maker documented in themedical record or documentation in themedical record that an advance careplan was discussed but the patient didnot wish or was not able to name asurrogate decision maker or provide anadvance care plan*The EHR-based reporting mechanismis no longer available for reporting thismeasure for 2014 and beyond.*We solicited but received no publiccomment on this measure. In an effortto align with the EHR IncentiveProgram, this measure will no longer bereportable via EHR beginning in 2014.AMA- PCPI/NCQAX XCMS-1600-FC 861

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsThe alignment of measures containedwithin multiple CMS reportingprograms eases the burden of reportingand encourages eligible professionals tosubmit quality clinical data on careprovided for Medicare beneficiaries.Alignment also promotes a robust datasource and consistency in analysis,which supports other quality programswithin CMS. For the reasons previouslystated, we are finalizing the removal ofthe EHR-based option beginning in2014.0098/48Effective Clinical CareUrinary Incontinence: Assessment ofPresence or Absence of UrinaryIncontinence in Women Aged 65Years and Older:Percentage offemale patients aged 65 years and olderwho were assessed for the presence orabsence of urinary incontinence within12 months*The EHR-based reporting mechanismis no longer available for reporting thismeasure for 2014 and beyond.*AMA- PCPI/NCQAX X XCMS-1600-FC 862

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsIn an effort to align with the EHRIncentive Program, this measure will nolonger be reportable via EHR beginningin 2014. The alignment of measurescontained within multiple CMSreporting programs eases the burden ofreporting and encourages eligibleprofessionals to submit quality clinicaldata on care provided for Medicarebeneficiaries. Alignment also promotesa robust data source and consistency inanalysis, which supports other qualityprograms within CMS. For the reasonspreviously stated, we are finalizing theremoval of the EHR-based optionbeginning in 2014.0099/49Effective Clinical CareUrinary Incontinence:Characterization of UrinaryIncontinence in Women Aged 65Years and Older:Percentage offemale patients aged 65 years and olderwith a diagnosis of urinary incontinencewhose urinary incontinence wascharacterized at least once within 12AMA- PCPI/NCQAX XCMS-1600-FC 863

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsmonthsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0100/50Person and CaregiverCentered Experienceand OutcomesUrinary Incontinence: Plan of Carefor Urinary Incontinence in WomenAged 65 Years and Older:Percentageof female patients aged 65 years andolder with a diagnosis of urinaryincontinence with a documented plan ofcare for urinary incontinence at leastonce within 12 monthsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAX X0091/51Effective Clinical CareChronic Obstructive PulmonaryDisease (COPD): SpirometryEvaluation:Percentage of patientsaged 18 years and older with adiagnosis of COPD who had spirometryevaluation results documentedAMA-PCPI X X XCMS-1600-FC 864

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0102/52Effective Clinical CareChronic Obstructive PulmonaryDisease (COPD): InhaledBronchodilator Therapy:Percentageof patients aged 18 years and older witha diagnosis of COPD and who have anFEV1/FVC less than 60% and havesymptoms who were prescribed aninhaled bronchodilatorThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA-PCPI X X X0047/53Effective Clinical CareAsthma: Pharmacologic Therapy forPersistent Asthma - AmbulatoryCare Setting:Percentage of patientsaged 5 through 64 years with adiagnosis of persistent asthma whowere prescribed long-term controlmedication*The claims-based reporting option isAMA- PCPI/NCQAX XCMS-1600-FC 865

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsno longer available for reporting thismeasure for 2014 and beyond.*We solicited but received no publiccomment on removing the claims-basedreporting mechanism as an option toreport this measure. 2012 claims dataindicates a low threshold of eligibleprofessionals reporting this measure viaclaims. CMS intends to streamline thereporting options available under thePQRS and to eliminate reportingoptions that are not widely used. Forthese reasons, we are finalizing theremoval of the claims-based option forthis measure beginning in 2014.0090/54Effective Clinical CareEmergency Medicine: 12-LeadElectrocardiogram (ECG) Performedfor Non-Traumatic Chest Pain:Percentage of patients aged 40 yearsand older with an emergencydepartment discharge diagnosis of nontraumatic chest pain who had a 12-leadelectrocardiogram (ECG) performedThis measure was finalized forAMA- PCPI/NCQAX XCMS-1600-FC 866

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0093/55Effective Clinical CareEmergency Medicine: 12-LeadElectrocardiogram (ECG) Performedfor Syncope:Percentage of patientsaged 60 years and older with anemergency department dischargediagnosis of syncope who had a 12-leadelectrocardiogram (ECG) performedThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAX X0232/56Effective Clinical CareEmergency Medicine: CommunityAcquired Bacterial Pneumonia(CAP): Vital Signs:Percentage ofpatients aged 18 years and older with adiagnosis of community-acquiredbacterial pneumonia (CAP) with vitalsigns documented and reviewedThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FRAMA- PCPI/NCQAX XCMS-1600-FC 867

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs69215).0096/59Effective Clinical CareEmergency Medicine: CommunityAcquired Bacterial Pneumonia(CAP): Empiric Antibiotic:Percentage of patients aged 18 yearsand older with a diagnosis ofcommunity-acquired bacterialpneumonia (CAP) with an appropriateempiric antibiotic prescribedThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAX X0001/64Effective Clinical CareAsthma: Assessment of AsthmaControl – Ambulatory Care Setting:Percentage of patients aged 5 through64 years with a diagnosis of asthmawho were evaluated at least once duringthe measurement period for asthmacontrol (comprising asthma impairmentand asthma risk)*The claims-based and EHR-basedreporting options are no longeravailable for reporting this measure forAMA- PCPI/NCQAX XCMS-1600-FC 868

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs2014 and beyond*We solicited but received no publiccomment on this measure, including nothaving this measure reportable via theclaims and EHR-based reportingmechanisms beginning ni 2014. 2012claims data indicates a low threshold ofeligible professionals reporting thismeasure via claims. CMS intends tostreamline the reporting optionsavailable under the PQRS and toeliminate reporting options that are notwidely used. Additionally, in an effortto align with the EHR IncentiveProgram, this measure will no longer bereportable via EHR beginning in 2014.The alignment of measures containedwithin multiple CMS reportingprograms eases the burden of reportingand encourages eligible professionals tosubmit quality clinical data on careprovided for Medicare beneficiaries.Alignment also promotes a robust datasource and consistency in analysis,which supports other quality programsCMS-1600-FC 869

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programswithin CMS. For these reasons, we arefinalizing the removal of this measurefrom the claims-based and EHR-basedreporting options beginning in 2014.0069/65154v2 Efficiency and CostReductionAppropriate Treatment for Childrenwith Upper Respiratory Infection(URI):Percentage of children 3months-18 years of age who werediagnosed with upper respiratoryinfection (URI) and were not dispensedan antibiotic prescription on or threedays after the episode.*The claims-based reporting option isno longer available for reporting thismeasure for 2014 and beyond,additionally, the EHR-based reportingoption is available for reporting thismeasure beginning in 2014.*We solicited but received no publiccomment on this measure. 2012 claimsdata indicates a low threshold ofeligible professionals reporting thismeasure via claims. CMS intends tostreamline the reporting optionsNCQA X X MU2CMS-1600-FC 870

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsavailable under the PQRS and toeliminate reporting options that are notwidely used. Additionally,in an effortto align with the EHR IncentiveProgram, this measure will bereportable via EHR beginning in 2014.The alignment of measures containedwithin multiple CMS reportingprograms eases the burden of reportingand encourages eligible professionals tosubmit quality clinical data on careprovided for Medicare beneficiaries.Alignment also promotes a robust datasource and consistency in analysis,which supports other quality programswithin CMS. For the reasons previouslystated, we are finalizing the removal ofthe claims-based option and theaddition of the EHR-based reportingoption for this measure beginning in2014.0002/66146v2 Efficiency and CostReductionAppropriate Testing for Childrenwith Pharyngitis:Percentage ofchildren 2-18 years of age who werediagnosed with pharyngitis, ordered anantibiotic and received a group ANCQA X X MU2CMS-1600-FC 871

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsstreptococcus (strep) test for theepisode.*The claims-based reporting option isno longer available for reporting thismeasure for 2014 and beyond.*We solicited but received no publiccomment on this measure. 2012 claimsdata indicates a low threshold ofeligible professionals reporting thismeasure via claims. CMS intends tostreamline the reporting optionsavailable under the PQRS and toeliminate reporting options that are notwidely used. For these reasons, we arefinalizing the removal of the claimsbased option for this measure beginningin 2014.0377/67Effective Clinical CareHematology: MyelodysplasticSyndrome (MDS) and AcuteLeukemias: BaselineCytogenetic Testing Performed onBone Marrow:Percentage of patientsaged 18 years and older with adiagnosis of myelodysplastic syndromeAMA- PCPI/ASHX XCMS-1600-FC 872

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs(MDS) or an acute leukemia who hadbaseline cytogenetic testing performedon bone marrowThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0378/68Effective Clinical CareHematology: MyelodysplasticSyndrome (MDS): Documentation ofIron Stores in Patients ReceivingErythropoietin Therapy:Percentageof patients aged 18 years and older witha diagnosis of myelodysplasticsyndrome (MDS) who are receivingerythropoietin therapy withdocumentation of iron stores within 60days prior to initiating erythropoietintherapyThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/ASHX X0380/69Effective Clinical CareHematology: Multiple Myeloma:Treatment with Bisphosphonates:AMA- PCPI/ASHX XCMS-1600-FC 873

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsPercentage of patients aged 18 yearsand older with a diagnosis of multiplemyeloma, not in remission, who wereprescribed or received intravenousbisphosphonate therapy within the 12-month reporting periodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0379/70Effective Clinical CareHematology: Chronic LymphocyticLeukemia (CLL): Baseline FlowCytometry:Percentage of patients aged 18years and older seen within a 12 monthreporting period with a diagnosis of chroniclymphocytic leukemia (CLL) made at anytime during or prior to the reporting periodwho had baseline flow cytometry studiesperformed and documented in the chartThis measure was finalized for inclusion in2014 PQRS in the CY 2013 PFS Final Rule(see Table 95 at 77 FR 69215).AMA- PCPI/ASHX X0387/71140v1 Effective Clinical CareBreast Cancer: Hormonal Therapyfor Stage IC-IIIC EstrogenReceptor/Progesterone Receptor(ER/PR) Positive Breast Cancer:Percentage of female patients aged 18AMA-PCPI/ASCO/NCCNX X X X MU2CMS-1600-FC 874

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsyears and older with Stage IC throughIIIC, ER or PR positive breast cancerwho were prescribed tamoxifen oraromatase inhibitor (AI) during the 12-month reporting periodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0385/72141v3 Effective Clinical CareColon Cancer: Chemotherapy forAJCC Stage III Colon CancerPatients:Percentage of patients aged18 through 80 years with AJCC StageIII colon cancer who are referred foradjuvant chemotherapy, prescribedadjuvant chemotherapy, or havepreviously received adjuvantchemotherapy within the 12-monthreporting period.This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA-PCPI/ASCO/NCCNX X X X MU20464/ Patient SafetyPrevention of Catheter-RelatedAMA-PCPI X XCMS-1600-FC 875

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs76Bloodstream Infections (CRBSI):Central Venous Catheter (CVC)Insertion Protocol:Percentage ofpatients, regardless of age, whoundergo CVC insertion for whom CVCwas inserted with all elements ofmaximal sterile barrier technique [capAND mask AND sterile gown ANDsterile gloves AND a large sterile sheetAND hand hygiene AND 2%chlorhexidine for cutaneous antisepsis(or acceptable alternative antiseptics percurrent guideline)] followedThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0323/81Communication andCare CoordinationAdult Kidney Disease: HemodialysisAdequacy: Solute:Percentage ofcalendar months within a 12-monthperiod during which patients aged 18years and older with a diagnosis of EndStage Renal Disease (ESRD) receivinghemodialysis three times a week for≥90 days who have a spKt/V≥1.2AMA-PCPI XCMS-1600-FC 876

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0321/82Communication andCare CoordinationAdult Kidney Disease: PeritonealDialysis Adequacy: Solute:Percentageof patients aged 18 years and older witha diagnosis of End Stage Renal Disease(ESRD) receiving peritoneal dialysiswho have a total Kt/V≥1.7 per weekmeasured once every 4 monthsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA-PCPI X0393/83Effective Clinical CareHepatitis C: Confirmation ofHepatitis C Viremia:Percentage ofpatients aged 18 years and older whoare hepatitis C antibody positive seenfor an initial evaluation for whomhepatitis C virus (HCV) RNA testingwas ordered or previously performedThis measure was finalized forAMA-PCPI XCMS-1600-FC 877

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0395/84Effective Clinical CareHepatitis C: Ribonucleic Acid (RNA)Testing Before Initiating Treatment:Percentage of patients aged 18 yearsand older with a diagnosis of chronichepatitis C who started antiviraltreatment within the 12 month reportingperiod for whom hepatitis C virus(HCV) genotype testing was performedwithin 12 months prior to initiation ofantiviral treatment*The claims-based reporting option isno longer available for reporting thismeasure for 2014 and beyond.*We solicited but received no publiccomment on this measure.CMS wouldlike to note that although this measurewas not listed in our proposal as havinga reporting option change, we arefinalizing it as registry-only beginningin 2014. CMS believes it necessary tomaintain consistency of clinicallyAMA-PCPI X XCMS-1600-FC 878

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsrelated measures available within aparticular reporting option; therefore,we are eliminating this measure fromthe claims-based reporting option. 2012claims data indicates a low threshold ofeligible professionals reporting thismeasure via claims.CMS intends tostreamline the reporting optionsavailable under the PQRS and toeliminate reporting options that are notwidely used.Eligible professionals who report thismeasure will still have an opportunityto participate in PQRS using theregistry-based reporting option. Forthese reasons, we are finalizing theremoval of the claims-based option forthis measure beginning in 2014.0396/85Effective Clinical CareHepatitis C: HCV Genotype TestingPrior to Treatment:Percentage ofpatients aged 18 years and older with adiagnosis of chronic hepatitis C whostarted antiviral treatment within the 12month reporting period for whomquantitative hepatitis C virus (HCV)AMA-PCPI X XCMS-1600-FC 879

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsRNA testing was performed within 12months prior to initiation of antiviraltreatment*The claims-based reporting option isno longer available for reporting thismeasure for 2014 and beyond.*We solicited but received no publiccomment on this measure.CMS wouldlike to note that although this measurewas not listed in our proposal as havinga reporting option change, we arefinalizing it as registry-only beginningin 2014. CMS believes it necessary tomaintain consistency of clinicallyrelated measures available within aparticular reporting option; therefore,we are eliminating this measure fromthe claims-based reporting option. 2012claims data indicates a low threshold ofeligible professionals reporting thismeasure via claims.CMS intends tostreamline the reporting optionsavailable under the PQRS and toeliminate reporting options that are notCMS-1600-FC 880

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programswidely used.Eligible professionals who report thismeasure will still have an opportunityto participate in PQRS using theregistry-based reporting option. Forthese reasons, we are finalizing theremoval of the claims-based option forthis measure beginning in 2014.0398/87Effective Clinical CareHepatitis C: Hepatitis C Virus (HCV)Ribonucleic Acid (RNA) TestingBetween 4-12 Weeks After Initiationof Treatment:Percentage of patientsaged 18 years and older with adiagnosis of chronic hepatitis C who arereceiving antiviral treatment for whomquantitative hepatitis C virus (HCV)RNA testing was performed between 4-12 weeks after the initiation of antiviraltreatment*The claims-based reporting option isno longer available for reporting thismeasure for 2014 and beyond.*We solicited but received no publicAMA-PCPI X XCMS-1600-FC 881

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programscomment on this measure. 2012 claimsdata indicates a low threshold ofeligible professionals reporting thismeasure via claims. CMS intends tostreamline the reporting optionsavailable under the PQRS and toeliminate reporting options that are notwidely used. For these reasons, we arefinalizing the removal of the claimsbased option for this measure beginningin 2014.0653/91Effective Clinical CareAcute Otitis Externa (AOE): TopicalTherapy:Percentage of patients aged 2years and older with a diagnosis ofAOE who were prescribed topicalpreparationsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA-PCPI X X0654/93Communication andCare CoordinationAcute Otitis Externa (AOE):Systemic Antimicrobial Therapy –Avoidance ofInappropriate Use:Percentage ofpatients aged 2 years and older with aAMA-PCPI X XCMS-1600-FC 882

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsdiagnosis of AOE who werenotprescribedsystemic antimicrobialtherapyThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0391/99Effective Clinical CareBreast Cancer Resection PathologyReporting: pT Category (PrimaryTumor) and pN Category (RegionalLymph Nodes) with HistologicGrade:Percentage of breast cancerresection pathology reports that includethe pT category (primary tumor), thepN category (regional lymph nodes),and the histologic gradeThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/CAPX X0392/100Effective Clinical CareColorectal Cancer ResectionPathology Reporting: pT Category(Primary Tumor) and pN Category(Regional Lymph Nodes) withAMA- PCPI/CAPX XCMS-1600-FC 883

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsHistologic Grade:Percentage of colonand rectum cancer resection pathologyreports that include the pT category(primary tumor), the pN category(regional lymph nodes) and thehistologic gradeThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0389/102129v3 Efficiency and CostReductionProstate Cancer: Avoidance ofOveruse of Bone Scan for StagingLow Risk Prostate Cancer Patients:Percentage of patients, regardless ofage, with a diagnosis of prostate cancerat low risk of recurrence receivinginterstitial prostate brachytherapy, ORexternal beam radiotherapy to theprostate, OR radical prostatectomy, ORcryotherapy who didnothave a bonescan performed at any time sincediagnosis of prostate cancerThis measure was finalized forinclusion in 2014 PQRS in the CY 2013AMA-PCPI X X X MU2CMS-1600-FC 884

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsPFS Final Rule (see Table 95 at 77 FR69215).0390/104Effective Clinical CareProstate Cancer: AdjuvantHormonal Therapy for High RiskProstate Cancer Patients:Percentageof patients, regardless of age, with adiagnosis of prostate cancer at high riskof recurrence receiving external beamradiotherapy to the prostate who wereprescribed adjuvant hormonal therapy(GnRH agonist or antagonist)This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA-PCPI X X0103/106Effective Clinical CareAdult Major Depressive Disorder(MDD): Comprehensive DepressionEvaluation: Diagnosis and Severity:Percentage of patients aged 18 years andolder with a new diagnosis or recurrentepisode of major depressive disorder(MDD) with evidence that they met theDiagnostic and Statistical Manual of MentalDisorders (DSM)-IV-TR criteria for MDDAND for whom there is an assessment ofdepression severity during the visit in whicha new diagnosis or recurrent episode wasidentifiedAMA-PCPI X XCMS-1600-FC 885

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsThis measure was finalized for inclusion in2014 PQRS in the CY 2013 PFS Final Rule(see Table 95 at 77 FR 69215).0104/107161v2 Effective Clinical CareAdult Major Depressive Disorder(MDD): Suicide Risk Assessment:Percentage of patients aged 18 yearsand older with a diagnosis of majordepressive disorder (MDD) with asuicide risk assessment completedduring the visit in which a newdiagnosis or recurrent episode wasidentified*The EHR-based reporting option isavailable for reporting this measurebeginning in 2014.*In an effort to align with the EHRIncentive Program, this measure will bereportable via EHR beginning in 2014.The alignment of measures containedwithin multiple CMS reportingprograms eases the burden of reportingand encourages eligible professionals tosubmit quality clinical data on careprovided for Medicare beneficiaries.AMA-PCPI X X X MU2CMS-1600-FC 886

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsAlignment also promotes a robust datasource and consistency in analysis,which supports other quality programswithin CMS. For these reasons, we arefinalizing the removal of the claimsbased option and the addition of theEHR-based reporting option for thismeasure beginning in 2014.0054/108Effective Clinical CareRheumatoid Arthritis (RA): DiseaseModifying Anti-Rheumatic Drug(DMARD) Therapy:Percentage ofpatients aged 18 years and older whowere diagnosed with RA and wereprescribed, dispensed, or administeredat least one ambulatory prescription fora DMARDThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).NCQA X X X0050/109Person and CaregiverCentered Experienceand OutcomesOsteoarthritis (OA): Function andPain Assessment:Percentage of patientvisits for patients aged 21 years andolder with a diagnosis of osteoarthritis(OA) with assessment for function andAMA-PCPI X XCMS-1600-FC 887

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramspainThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0041/110147v2 Community/Population HealthPreventive Care and Screening:Influenza Immunization:Percentageof patients aged 6 months and olderseen for a visit between October 1 andMarch 31 who received an influenzaimmunization OR who reportedprevious receipt of an influenzaimmunizationThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA-PCPI X X X X X MU2ACO0043/111127v2 Effective Clinical CarePneumonia Vaccination Status forOlder Adults:Percentage of patients65 years of age and older who haveever received a pneumococcal vaccine.This measure was finalized forinclusion in 2014 PQRS in the CY 2013NCQA X X X X X MU2ACOCMS-1600-FC 888

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsPFS Final Rule (see Table 95 at 77 FR69215).N/A/112125v2 Effective Clinical CareBreast Cancer Screening:Percentageof women 50 through 74 years of agewho had a mammogram to screen forbreast cancer within 27 monthsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).NCQA X X X X X MU2ACO0034/113130v2 Effective Clinical CareColorectal Cancer Screening:Percentage of patients 50-75 years ofage who had appropriate screening forcolorectal cancer.This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).NCQA X X X X X MU2ACO0058/116Efficiency and CostReductionAntibiotic Treatment for Adults withAcute Bronchitis: Avoidance ofInappropriate Use:Percentage ofadults 18 through 64 years of age with adiagnosis of acute bronchitis who werenot prescribed or dispensedanNCQA XCMS-1600-FC 889

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsantibiotic prescription on or 3 days afterthe episode*The claims-based reporting option isno longer available for reporting thismeasure for 2014 and beyond.*2012 claims data indicates a lowthreshold of eligible professionalsreporting this measure via claims.CMSintends to streamline the reportingoptions available under the PQRS andto eliminate reporting options that arenot widely used.For these reasons, weare finalizing the removal of the claimsbased reporting option beginning in2014.0055/117131v2 Effective Clinical CareDiabetes: Eye Exam:Percentage ofpatients 18-75 years of age withdiabetes who had a retinal or dilatedeye exam by an eye care professionalduring the measurement period or anegative retinal eye exam (no evidenceof retinopathy) in the 12 months priorto the measurement periodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013NCQA X X X X MU2CMS-1600-FC 890

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsPFS Final Rule (see Table 95 at 77 FR69215).0066/118Effective Clinical CareCoronary Artery Disease (CAD):Angiotensin-Converting Enzyme(ACE) Inhibitor or AngiotensinReceptor Blocker (ARB) Therapy -Diabetes or Left Ventricular SystolicDysfunction (LVEF < 40%):Percentage of patients aged 18 yearsand older with a diagnosis of coronaryartery disease seen within a 12 monthperiod who also have diabetes OR acurrent or prior Left VentricularEjection Fraction (LVEF) < 40% whowere prescribed ACE inhibitor or ARBtherapyThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/ACCF/AHAX X ACO0062/119134v2 Effective Clinical CareDiabetes: Urine Protein Screening:Thepercentage of patients 18-75 years of agewith diabetes who had a nephropathyscreening test or evidence of nephropathyduring the measurement period.This measure was finalized for inclusion inNCQA X X X X MU2CMS-1600-FC 891

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs2014 PQRS in the CY 2013 PFS Final Rule(see Table 95 at 77 FR 69215).1668/121Effective Clinical CareAdult Kidney Disease: LaboratoryTesting (Lipid Profile):Percentage ofpatients aged 18 years and older with adiagnosis of chronic kidney disease(CKD) (stage 3, 4, or 5, not receivingRenal Replacement Therapy [RRT])who had a fasting lipid profileperformed at least once within a 12-month periodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA-PCPI X X XAQAadopted/122Effective Clinical CareAdult Kidney Disease: BloodPressure Management:Percentage ofpatient visits for those patients aged 18years and older with a diagnosis ofchronic kidney disease (CKD) (stage 3,4, or 5, not receiving RenalReplacement Therapy [RRT]) andproteinuria with a blood pressure <130/80 mmHg OR≥130/80 mmHgwith a documented plan of careAMA-PCPI X X XCMS-1600-FC 892

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).1666/123Effective Clinical CareAdult Kidney Disease: Patients OnErythropoiesis-Stimulating Agent(ESA) - Hemoglobin Level > 12.0g/dL:Percentage of calendar monthswithin a 12-month period during whicha hemoglobin level is measured forpatients aged 18 years and older with adiagnosis of advanced chronic kidneydisease (CKD) (stage 4 or 5, notreceiving Renal Replacement Therapy[RRT]) or End Stage Renal Disease(ESRD) (who are on hemodialysis orperitoneal dialysis) who are alsoreceiving erythropoiesis-stimulatingagent (ESA) therapy have a hemoglobinlevel > 12.0 g/dLThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA-PCPI X X X0417/ Effective Clinical CareDiabetes Mellitus: Diabetic Foot andAPMA XCMS-1600-FC 893

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs126Ankle Care, Peripheral Neuropathy –Neurological Evaluation:Percentageof patients aged 18 years and older witha diagnosis of diabetes mellitus whohad a neurological examination of theirlower extremities within 12 months*The claims-based reporting option isno longer available for reporting thismeasure for 2014 and beyond.*2012 claims data indicates a lowthreshold of eligible professionalsreporting this measure via claims.CMSintends to streamline the reportingoptions available under the PQRS andto eliminate reporting options that arenot widely used.For these reasons, weare finalizing the removal of the claimsbased reporting option beginning in2014.0416/127Effective Clinical CareDiabetes Mellitus: Diabetic Foot andAnkle Care, Ulcer Prevention –Evaluation of Footwear:Percentage ofpatients aged 18 years and older with adiagnosis of diabetes mellitus who wereAPMA XCMS-1600-FC 894

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsevaluated for proper footwear andsizing*The claims-based reporting option isno longer available for reporting thismeasure for 2014 and beyond.*2012 claims data indicates a lowthreshold of eligible professionalsreporting this measure via claims.CMSintends to streamline the reportingoptions available under the PQRS andto eliminate reporting options that arenot widely used.For these reasons, weare finalizing the removal of the claimsbased reporting option beginning in2014.0421/12869v2 Community/Population HealthPreventive Care and Screening: BodyMass Index (BMI) Screening and FollowUp:Percentage of patients aged 18 yearsand older with a documented BMI duringthe current encounter or during the previous6 months, AND when the BMI isoutside ofnormal parameters, a follow-up plan isdocumented during the encounter or duringthe previous 6 months of the encounterNormal Parameters:Age 65 years andCMS X X X X X MU2ACOCMS-1600-FC 895

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsolder BMI≥23 and < 30; Age 18 – 64years BMI≥18.5 and < 25This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0419/13068v3 Patient SafetyDocumentation of CurrentMedications in the Medical Record:Percentage of visits for patients aged 18years and older for which the eligibleprofessional attests to documenting alist of current medications using allimmediate resources available on thedate of the encounter. This listmustinclude ALL known prescriptions,over-the-counters, herbals, andvitamin/mineral/dietary (nutritional)supplements ANDmustcontain themedications’ name, dosage, frequencyand route of administration.*The EHR-based reporting option isavailable for reporting this measurebeginning in 2014.*CMS X X X X MU2CMS-1600-FC 896

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsIn an effort to align with the EHRIncentive Program, this measure will bereportable via EHR beginning in 2014.The alignment of measures containedwithin multiple CMS reportingprograms eases the burden of reportingand encourages eligible professionals tosubmit quality clinical data on careprovided for Medicare beneficiaries.Alignment also promotes a robust datasource and consistency in analysis,which supports other quality programswithin CMS. For the reasons previouslystated, we are finalizing the addition ofthe EHR-based option beginning in2014.0420/131Community/Population HealthPain Assessment and Follow-Up:Percentage of visits for patients aged 18years and older with documentation of apain assessment using a standardizedtool(s) on each visit ANDdocumentation of a follow-up planwhen pain is presentThis measure was finalized forinclusion in 2014 PQRS in the CY 2013CMS X XCMS-1600-FC 897

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsPFS Final Rule (see Table 95 at 77 FR69215).0418/1342v3 Community/Population HealthPreventive Care and Screening:Screening for Clinical Depression andFollow-Up Plan:Percentage of patientsaged 12 years and older screened forclinical depression on the date of theencounter using an age appropriatestandardized depression screening toolAND if positive, a follow-up plan isdocumented on the date of the positivescreen.*The EHR-based reporting option isavailable for reporting this measurebeginning in 2014.*In an effort to align with the EHR IncentiveProgram, this measure will be reportablevia EHR beginning in 2014. The alignmentof measures contained within multiple CMSreporting programs eases the burden ofreporting and encourages eligibleprofessionals to submit quality clinical dataon care provided for Medicarebeneficiaries. Alignment also promotes arobust data source and consistency inanalysis, which supports other qualityprograms within CMS. For the reasonspreviously stated, we are finalizing theaddition of the EHR-based optionbeginning in 2014.CMS X X X X MU2ACO0650/ Effective Clinical CareMelanoma: Continuity of Care –AMA- XCMS-1600-FC 898

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs137Recall System:Percentage of patients,regardless of age, with a currentdiagnosis of melanoma or a history ofmelanoma whose information wasentered, at least once within a 12 monthperiod, into a recall system thatincludes:• A target date for the next completephysical skin exam, AND• A process to follow up with patientswho either did not make anappointment within the specifiedtimeframe or who missed a scheduledappointmentThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).PCPI/NCQAN/A/138Communication andCare CoordinationMelanoma: Coordination of Care:Percentage of patient visits, regardlessof age, with a new occurrence ofmelanoma who have a treatment plandocumented in the chart that wascommunicated to the physician(s)providing continuing care within 1AMAPCPI/NCQAXCMS-1600-FC 899

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsmonth of diagnosisThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0566/140Effective Clinical CareAge-Related Macular Degeneration(AMD): Counseling on AntioxidantSupplement:Percentage of patientsaged 50 years and older with adiagnosis of age-related maculardegeneration (AMD) or theircaregiver(s) who were counseled within12 months on the benefits and/or risksof the Age-Related Eye Disease Study(AREDS) formulation for preventingprogression of AMDThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAXX0563/141Communication andCare CoordinationPrimary Open-Angle Glaucoma(POAG): Reduction of IntraocularPressure (IOP) by 15% ORDocumentation of a Plan of Care:AMA- PCPI/NCQAX XCMS-1600-FC 900

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsPercentage of patients aged 18 yearsand older with a diagnosis of primaryopen-angle glaucoma (POAG) whoseglaucoma treatment has not failed (themost recent IOP was reduced by at least15% from the pre- intervention level)OR if the most recent IOP was notreduced by at least 15% from the preintervention level, a plan of care wasdocumented within 12 monthsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0051/142Effective Clinical CareOsteoarthritis (OA): Assessment forUse of Anti-Inflammatory orAnalgesic Over-the-Counter (OTC)Medications:Percentage of patientvisits for patients aged 21 years andolder with a diagnosis of osteoarthritis(OA) with an assessment for use ofanti-inflammatory or analgesic overthe-counter (OTC) medicationsThis measure was finalized forAMA-PCPI X XCMS-1600-FC 901

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0384/143157v2 Person and CaregiverCentered Experienceand OutcomesOncology: Medical and Radiation –Pain Intensity Quantified:Percentageof patient visits, regardless of patientage, with a diagnosis of cancercurrently receiving chemotherapy orradiation therapy in which painintensity is quantified*The EHR-based reporting option isavailable for reporting this measurebeginning in 2014.*In an effort to align with the EHRIncentive Program, this measure will bereportable via EHR beginning in 2014.The alignment of measures containedwithin multiple CMS reportingprograms eases the burden of reportingand encourages eligible professionals tosubmit quality clinical data on careprovided for Medicare beneficiaries.Alignment also promotes a robust datasource and consistency in analysis,AMA-PCPI X X X MU2CMS-1600-FC 902

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programswhich supports other quality programswithin CMS. For the reasons previouslystated, we are finalizing the addition ofthe EHR-based option beginning in2014.0383/144Person and CaregiverCentered Experienceand OutcomesOncology: Medical and Radiation –Plan of Care for Pain:Percentage ofvisits for patients, regardless of age,with a diagnosis of cancer currentlyreceiving chemotherapy or radiationtherapy who report having pain with adocumented plan of care to address painThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA-PCPI X X0510/145Patient SafetyRadiology: Exposure Time Reportedfor Procedures Using Fluoroscopy:Percentage of final reports forprocedures using fluoroscopy thatinclude documentation of radiationexposure or exposure timeThis measure was finalized forinclusion in 2014 PQRS in the CY 2013AMA- PCPI/NCQAX XCMS-1600-FC 903

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsPFS Final Rule (see Table 95 at 77 FR69215).0508/146Efficiency and CostReductionRadiology: Inappropriate Use of“Probably Benign” AssessmentCategory in MammographyScreening:Percentage of final reportsfor screening mammograms that areclassified as “probably benign”This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAX XN/A/147Communication andCare CoordinationNuclear Medicine: Correlation withExisting Imaging Studies for AllPatients Undergoing BoneScintigraphy:Percentage of finalreports for all patients, regardless ofage, undergoing bone scintigraphy thatinclude physician documentation ofcorrelation with existing relevantimaging studies (e.g., x-ray, MRI, CT,etc.) that were performedThis measure was finalized forinclusion in 2014 PQRS in the CY 2013AMA-PCPI X XCMS-1600-FC 904

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsPFS Final Rule (see Table 95 at 77 FR69215).0322/148Efficiency and CostReductionBack Pain: Initial Visit:Thepercentage of patients aged 18 through79 years with a diagnosis of back painor undergoing back surgery who hadback pain and function assessed duringthe initial visit to the clinician for theepisode of back painThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).NCQA X0319/149Effective Clinical CareBack Pain: Physical Exam:Percentage of patients aged 18 through79 years with a diagnosis of back painor undergoing back surgery whoreceived a physical examination at theinitial visit to the clinician for theepisode of back painThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).NCQA XCMS-1600-FC 905

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs0314/150Effective Clinical CareBack Pain: Advice for NormalActivities:The percentage of patientsaged 18 through 79 years with adiagnosis of back pain or undergoingback surgery who received advice fornormal activities at the initial visit tothe clinician for the episode of backpainThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).NCQA X0313/151Effective Clinical CareBack Pain: Advice Against Bed Rest:The percentage of patients aged 18through 79 years with a diagnosis ofback pain or undergoing back surgerywho received advice against bed restlasting four days or longer at the initialvisit to the clinician for the episode ofback painThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).NCQA XCMS-1600-FC 906

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs0101/154Patient SafetyFalls: Risk Assessment:Percentage ofpatients aged 65 years and older with ahistory of falls who had a riskassessment for falls completed within12 monthsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAX X0101/155Communication andCare CoordinationFalls: Plan of Care:Percentage ofpatients aged 65 years and older with ahistory of falls who had a plan of carefor falls documented within 12 monthsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAX X0382/156Patient SafetyOncology: Radiation Dose Limits toNormal Tissues:Percentage ofpatients, regardless of age, with adiagnosis of pancreatic or lung cancerreceiving 3D conformal radiationtherapy with documentation in medicalrecord that radiation dose limits toAMA-PCPI X XCMS-1600-FC 907

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsnormal tissues were established prior tothe initiation of a course of 3Dconformal radiation for a minimum oftwo tissuesThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0455/157Patient SafetyThoracic Surgery: Recording ofClinical Stage Prior to Lung Canceror Esophageal Cancer Resection:Percentage of surgical patients aged 18years and older undergoing resectionfor lung or esophageal cancer who hadclinical staging provided prior tosurgeryThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).STS X X0404/159Effective Clinical CareHIV/AIDS: CD4+ Cell Count orCD4+ Percentage Performed:Percentage of patients aged 6 monthsand older with a diagnosis ofAMA- PCPI/NCQAX XCMS-1600-FC 908

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsHIV/AIDS for whom a CD4+ cellcount or CD4+ cell percentage wasperformed at least once every 6 monthsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0405/16052v2 Effective Clinical CareHIV/AIDS: Pneumocystis jirovecipneumonia (PCP) prophylaxis:Percentage of patients aged 6 weeksand older with a diagnosis ofHIV/AIDS who were prescribedPneumocystis jiroveci pneumonia(PCP) prophylaxis*The EHR-based reporting option isavailable for reporting this measurebeginning in 2014.*In an effort to align with the EHRIncentive Program, this measure will bereportable via EHR beginning in 2014.The alignment of measures containedwithin multiple CMS reportingprograms eases the burden of reportingNCQA X X X MU2CMS-1600-FC 909

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsand encourages eligible professionals tosubmit quality clinical data on careprovided for Medicare beneficiaries.Alignment also promotes a robust datasource and consistency in analysis,which supports other quality programswithin CMS. For the reasons previouslystated, we are finalizing the addition ofthe EHR-based option beginning in2014.0056/163123v2 Effective Clinical CareDiabetes: Foot Exam:Percentage ofpatients aged 18-75 years of age withdiabetes who had a foot exam duringthe measurement period.This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).NCQA X X X X MU20129/164Effective Clinical CareCoronary Artery Bypass Graft(CABG): Prolonged Intubation:Percentage of patients aged 18 yearsand older undergoing isolated CABGsurgery who require postoperativeintubation > 24 hoursSTS X XCMS-1600-FC 910

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0130/165Effective Clinical CareCoronary Artery Bypass Graft(CABG): Deep Sternal WoundInfection Rate:Percentage of patientsaged 18 years and older undergoingisolated CABG surgery who, within 30days postoperatively, develop deepsternal wound infection involvingmuscle, bone, and/or mediastinumrequiring operative interventionThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).STS X X0131/166Effective Clinical CareCoronary Artery Bypass Graft(CABG): Stroke:Percentage ofpatients aged 18 years and olderundergoing isolated CABG surgerywho have apostoperativestroke (i.e.,any confirmed neurological deficit ofabrupt onset caused by a disturbance inblood supply to the brain) that did notSTS X XCMS-1600-FC 911

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsresolve within 24 hoursThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0114/167Effective Clinical CareCoronary Artery Bypass Graft(CABG): Postoperative RenalFailure:Percentage of patients aged 18years and older undergoing isolatedCABG surgery (without pre-existingrenal failure) who developpostoperative renal failure or requiredialysisThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).STS X X0115/168Effective Clinical CareCoronary Artery Bypass Graft(CABG): Surgical Re-Exploration:Percentage of patients aged 18 yearsand older undergoing isolated CABGsurgery who require a return to theoperating room (OR) during the currenthospitalization for mediastinal bleedingSTS X XCMS-1600-FC 912

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programswith or without tamponade, graftocclusion, valve dysfunction, or othercardiac reasonThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0116/169Effective Clinical CareCoronary Artery Bypass Graft(CABG): Antiplatelet Medications atDischarge:Percentage of patients aged 18 yearsand older undergoing isolated CABGsurgery who were discharged onantiplatelet medicationThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).STS X X0117/170Effective Clinical CareCoronary Artery Bypass Graft(CABG): Beta-BlockersAdministered at Discharge:Percentage of patients aged 18 yearsand older undergoing isolated CABGsurgery who were discharged on betaSTS X XCMS-1600-FC 913

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsblockersThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0118/171Effective Clinical CareCoronary Artery Bypass Graft(CABG): Anti-Lipid Treatment atDischarge:Percentage of patients aged18 years and older undergoing isolatedCABG surgery who were discharged ona statin or other lipid-lowering regimenThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).STS X X0259/172Effective Clinical CareHemodialysis Vascular AccessDecision-Making by Surgeon toMaximize Placement of AutogenousArterial Venous (AV) Fistula:Percentage of patients aged 18 yearsand older with a diagnosis of advancedChronic Kidney Disease (CKD) (stage3, 4 or 5) or End Stage Renal Disease(ESRD) requiring hemodialysisSVS X XCMS-1600-FC 914

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsvascular access documented by surgeonto have received autogenous AV fistulaThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AQAadopted/173Community/Population HealthPreventive Care and Screening:Unhealthy Alcohol Use – Screening:Percentage of patients aged 18 yearsand older who were screened forunhealthy alcohol use using asystematic screening method within 24months*The claims-based and EHR-basedreporting options have been removedfrom this measure for 2014 PQRS.*This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA-PCPI X XAQAadopted/176Effective Clinical CareRheumatoid Arthritis (RA):Tuberculosis Screening:Percentage ofpatients aged 18 years and older with aAMA- PCPI X XCMS-1600-FC 915

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsdiagnosis of rheumatoid arthritis (RA)who have documentation of atuberculosis (TB) screening performedand results interpreted within 6 monthsprior to receiving a first course oftherapy using a biologic diseasemodifying anti-rheumatic drug(DMARD)*The claims-based reporting option isno longer available for reporting thismeasure for 2014 and beyond.*2012 claims data indicates a lowthreshold of eligible professionalsreporting this measure via claims.CMSintends to streamline the reportingoptions available under the PQRS andto eliminate reporting options that arenot widely used.For these reasons, weare finalizing the removal of the claimsbased option for 2014 and beyond.AQAadopted/177Effective Clinical CareRheumatoid Arthritis (RA): PeriodicAssessment of Disease Activity:Percentage of patients aged 18 yearsand older with a diagnosis ofAMA- PCPI X XCMS-1600-FC 916

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsrheumatoid arthritis (RA) who have anassessment and classification of diseaseactivity within 12 months*The claims-based reporting option isno longer available for reporting thismeasure for 2014 and beyond.*2012 claims data indicates a lowthreshold of eligible professionalsreporting this measure via claims.CMSintends to streamline the reportingoptions available under the PQRS andto eliminate reporting options that arenot widely used.For these reasons, weare finalizing the removal of the claimsbased option for 2014 and beyond.AQAadopted/178Effective Clinical CareRheumatoid Arthritis (RA):Functional Status Assessment:Percentage of patients aged 18 yearsand older with a diagnosis ofrheumatoid arthritis (RA) for whom afunctional status assessment wasperformed at least once within 12monthsAMA- PCPI X XCMS-1600-FC 917

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs*The claims-based reporting option isno longer available for reporting thismeasure for 2014 and beyond.*2012 claims data indicates a lowthreshold of eligible professionalsreporting this measure via claims.CMSintends to streamline the reportingoptions available under the PQRS andto eliminate reporting options that arenot widely used.For these reasons, weare finalizing the removal of the claimsbased option for 2014 and beyond.AQAadopted/179Effective Clinical CareRheumatoid Arthritis (RA):Assessment and Classification ofDisease Prognosis:Percentage ofpatients aged 18 years and older with adiagnosis of rheumatoid arthritis (RA)who have an assessment andclassification of disease prognosis atleast once within 12 months*The claims-based reporting option isno longer available for reporting thismeasure for 2014 and beyond.*AMA- PCPI X XCMS-1600-FC 918

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs2012 claims data indicates a lowthreshold of eligible professionalsreporting this measure via claims.CMSintends to streamline the reportingoptions available under the PQRS andto eliminate reporting options that arenot widely used.For these reasons, weare finalizing the removal of the claimsbased option for 2014 and beyond.AQAadopted/180Communication andCare CoordinationRheumatoid Arthritis (RA):Glucocorticoid Management:Percentage of patients aged 18 yearsand older with a diagnosis ofrheumatoid arthritis (RA) who havebeen assessed for glucocorticoid useand, for those on prolonged doses ofprednisone≥10 mg daily (orequivalent) with improvement or nochange in disease activity,documentation of glucocorticoidmanagement plan within 12 months*The claims-based reporting option isno longer available for reporting thismeasure for 2014 and beyond.*AMA- PCPI X XCMS-1600-FC 919

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsCMS would like to note that althoughthis measure was not listed in ourproposal as having a reporting optionchange, we are finalizing it as registryonly beginning in 2014. CMS believesit necessary to maintain consistency ofclinically-related measures availablewithin a particular reporting option;therefore, we are eliminating thismeasure from the claims-basedreporting option. 2012 claims dataindicates a low threshold of eligibleprofessionals reporting this measure viaclaims.CMS intends to streamline thereporting options available under thePQRS and to eliminate reportingoptions that are not widely used.Eligible professionals who report thismeasure will still have an opportunityto participate in PQRS using theregistry-based reporting option. Forthese reasons, we are finalizing theremoval of the claims-based option forthis measure beginning in 2014.AQA Patient SafetyElder Maltreatment Screen andCMS X XCMS-1600-FC 920

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsadopted/181Follow-Up Plan:Percentage of patientsaged 65 years and older with adocumented elder maltreatment screenusing an Elder Maltreatment ScreeningTool on the date of encounter AND adocumented follow-up plan on the dateof the positive screenThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AQAadopted/182Communication andCare CoordinationFunctional Outcome Assessment:Percentage of visits for patients aged 18years and older with documentation of acurrent functional outcome assessmentusing a standardized functionaloutcome assessment tool on the date ofencounter AND documentation of acare plan based on identified functionaloutcome deficiencies on the date of theidentified deficienciesThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FRCMS X XCMS-1600-FC 921

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs69215).0399/183Community/PopulationHealthHepatitis C: Hepatitis A Vaccinationin Patients with Hepatitis C Virus(HCV):Percentage of patients aged 18years and older with a diagnosis ofchronic hepatitis C who have receivedat least one injection of hepatitis Avaccine, or who have documentedimmunity to hepatitis A*The claims-based reporting option isno longer available for reporting thismeasure for 2014 and beyond.*CMS would like to note that althoughthis measure was not listed in ourproposal as having a reporting optionchange, we are finalizing it as registryonly beginning in 2014. CMS believesit necessary to maintain consistency ofclinically-related measures availablewithin a particular reporting option;therefore, we are eliminating thismeasure from the claims-basedreporting option. 2012 claims dataindicates a low threshold of eligibleAMA-PCPI X XCMS-1600-FC 922

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsprofessionals reporting this measure viaclaims.CMS intends to streamline thereporting options available under thePQRS and to eliminate reportingoptions that are not widely used.Eligible professionals who report thismeasure will still have an opportunityto participate in PQRS using theregistry-based reporting option. Forthese reasons, we are finalizing theremoval of the claims-based option forthis measure beginning in 2014.0659/185Communication andCare CoordinationEndoscopy/Polyp Surveillance:Colonoscopy Interval for Patientswith a History of AdenomatousPolyps – Avoidance of InappropriateUse:Percentage of patients aged 18years and older receiving a surveillancecolonoscopy, with a history of a prioradenomatous polyp(s) in previouscolonoscopy findings, who had aninterval of 3 or more years since theirlast colonoscopyThis measure was finalized forAMA- PCPI/NCQAX XCMS-1600-FC 923

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/187Effective Clinical CareStroke and Stroke Rehabilitation:Thrombolytic Therapy:Percentage ofpatients aged 18 years and older with adiagnosis of acute ischemic stroke whoarrive at the hospital within two hoursof time last known well and for whomIV t-PA was initiated within three hoursof time last known wellThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AHA/ASA/ TJCX0565/191133v2 Effective Clinical CareCataracts: 20/40 or Better VisualAcuity within 90 Days FollowingCataract Surgery:Percentage ofpatients aged 18 years and older with adiagnosis of uncomplicated cataractwho had cataract surgery and nosignificant ocular conditions impactingthe visual outcome of surgery and hadbest-corrected visual acuity of 20/40 orbetter (distance or near) achievedAMA- PCPI/NCQAX X X MU2CMS-1600-FC 924

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programswithin 90 days following the cataractsurgery*The EHR-based reporting option isavailable for reporting this measurebeginning in 2014.*In an effort to align with the EHRIncentive Program, this measure will bereportable via EHR beginning in 2014.The alignment of measures containedwithin multiple CMS reportingprograms eases the burden of reportingand encourages eligible professionals tosubmit quality clinical data on careprovided for Medicare beneficiaries.Alignment also promotes a robust datasource and consistency in analysis,which supports other quality programswithin CMS. For these reasons, we arefinalizing the addition of the EHRbased reporting option for this measurebeginning in 2014.0564/192132v2 Patient SafetyCataracts: Complications within 30Days Following Cataract SurgeryRequiring Additional SurgicalAMA- PCPI/NCQAX X X MU2CMS-1600-FC 925

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsProcedures:Percentage of patientsaged 18 years and older with adiagnosis of uncomplicated cataractwho had cataract surgery and had anyof a specified list of surgical proceduresin the 30 days following cataractsurgery which would indicate theoccurrence of any of the followingmajor complications: retained nuclearfragments, endophthalmitis, dislocatedor wrong power IOL, retinaldetachment, or wound dehiscence*The EHR-based reporting option isavailable for reporting this measurebeginning in 2014.*In an effort to align with the EHRIncentive Program, this measure will bereportable via EHR beginning in 2014.The alignment of measures containedwithin multiple CMS reportingprograms eases the burden of reportingand encourages eligible professionals tosubmit quality clinical data on careprovided for Medicare beneficiaries.CMS-1600-FC 926

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsAlignment also promotes a robust datasource and consistency in analysis,which supports other quality programswithin CMS. For these reasons, we arefinalizing the addition of the EHRbased reporting option for this measurebeginning in 2014.0454/193Patient SafetyPerioperative TemperatureManagement:Percentage of patients,regardless of age, undergoing surgicalor therapeutic procedures under generalor neuraxial anesthesia of 60 minutesduration or longer, except patientsundergoing cardiopulmonary bypass,for whomeitheractive warming wasused intraoperatively for the purpose ofmaintaining normothermia, OR at leastone body temperature equal to orgreater than 36 degrees Centigrade (or96.8 degrees Fahrenheit) was recordedwithin the 30 minutes immediatelybefore or the 15 minutes immediatelyafter anesthesia end timeThis measure was finalized forinclusion in 2014 PQRS in the CY 2013AMA-PCPI X XCMS-1600-FC 927

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsPFS Final Rule (see Table 95 at 77 FR69215).0386/194Effective Clinical CareOncology: Cancer StageDocumented:Percentage of patients,regardless of age, with a diagnosis ofcancer who are seen in the ambulatorysetting who have a baseline AmericanJoint Committee on Cancer (AJCC)cancer stage or documentation that thecancer is metastatic in the medicalrecord at least once during the 12month reporting periodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/ASCOX X X0507/195Effective Clinical CareRadiology: Stenosis Measurement inCarotid Imaging Reports:Percentageof final reports for carotid imagingstudies (neck magnetic resonanceangiography [MRA], neck computedtomography angiography [CTA], neckduplex ultrasound, carotid angiogram)performed that include direct or indirectreference to measurements of distalAMA- PCPI/NCQAX XCMS-1600-FC 928

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsinternal carotid diameter as thedenominator for stenosis measurementThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0074/197Effective Clinical CareCoronary Artery Disease (CAD):Lipid Control:Percentage of patientsaged 18 years and older with adiagnosis of coronary artery diseaseseen within a 12 month period whohave a LDL-C result < 100 mg/dL ORpatients who have a LDL-C result≥100 mg/dL and have a documented planof care to achieve LDL-C < 100 mg/dL,including at a minimum the prescriptionof a statin*The EHR-based reporting mechanismis no longer available for reporting thismeasure for 2014 and beyond.*In an effort to align with the EHRIncentive Program, this measure will nolonger be reportable via EHR beginningAMA- PCPI/ACCF/AHAX X X ACOCMS-1600-FC 929

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsin 2014. The alignment of measurescontained within multiple CMSreporting programs eases the burden ofreporting and encourages eligibleprofessionals to submit quality clinicaldata on care provided for Medicarebeneficiaries. Alignment also promotesa robust data source and consistency inanalysis, which supports other qualityprograms within CMS. For the reasonspreviously stated, we are finalizing theremoval of the EHR-based optionbeginning in 2014.0079/198Effective Clinical CareHeart Failure: Left VentricularEjection Fraction (LVEF)Assessment:Percentage of patientsaged 18 years and older with adiagnosis of heart failure for whom thequantitative or qualitative results of arecent or prior [any time in the past]LVEF assessment is documented withina 12 month periodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FRAMA- PCPI/ACCF/AHAX XCMS-1600-FC 930

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs69215).0068/204164v2 Effective Clinical CareIschemic Vascular Disease (IVD):Use of Aspirin or AnotherAntithrombotic:Percentage of patients18 years of age and older who weredischarged alive for acute myocardialinfarction (AMI), coronary arterybypass graft (CABG) or percutaneouscoronary interventions (PCI) in the 12months prior to the measurementperiod, or who had an active diagnosisof ischemic vascular disease (IVD)during the measurement period, andwho had documentation of use ofaspirin or another antithrombotic duringthe measurement period.This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).NCQA X X X X X MU2ACOMillionHearts0409/205 Effective Clinical CareHIV/AIDS: Sexually TransmittedDisease Screening for Chlamydia,Gonorrhea, and Syphilis:Percentage of patients aged 13 yearsand older with a diagnosis ofHIV/AIDS for whom chlamydia,AMA-PCPI/NCQAX XCMS-1600-FC 931

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsgonorrhea and syphilis screenings wereperformed at least once since thediagnosis of HIV infectionThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0422/217Communication andCare CoordinationFunctional Deficit: Change in RiskAdjusted Functional Status forPatients with Knee Impairments:Percentage of patients aged 18 or olderthat receive treatment for a functionaldeficit secondary to a diagnosis thataffects the knee in which the change intheir Risk-Adjusted Functional Status ismeasuredThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).FOTO X0423/218Communication andCare CoordinationFunctional Deficit: Change in RiskAdjusted Functional Status forPatients with Hip Impairments:Percentage of patients aged 18 or olderFOTO XCMS-1600-FC 932

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsthat receive treatment for a functionaldeficit secondary to a diagnosis thataffects the hip in which the change intheir Risk-Adjusted Functional Status ismeasuredThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0424/219Communication andCare CoordinationFunctional Deficit: Change in RiskAdjusted Functional Status forPatients with Lower Leg, Foot orAnkle Impairments:Percentage ofpatients aged 18 or older that receivetreatment for a functional deficitsecondary to a diagnosis that affects thelower leg, foot or ankle in which thechange in their Risk-AdjustedFunctional Status is measuredThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).FOTO X0425/ Communication andFunctional Deficit: Change in Risk-FOTO XCMS-1600-FC 933

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs220 Care CoordinationAdjusted Functional Status forPatients with Lumbar SpineImpairments:Percentage of patientsaged 18 or older that receive treatmentfor a functional deficit secondary to adiagnosis that affects the lumbar spinein which the change in their RiskAdjusted Functional Status is measuredThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0426/221Communication andCare CoordinationFunctional Deficit: Change in RiskAdjusted Functional Status forPatients with Shoulder Impairments:Percentage of patients aged 18 or olderthat receive treatment for a functionaldeficit secondary to a diagnosis thataffects the shoulder in which the changein their Risk-Adjusted Functional Statusis measuredThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FRFOTO XCMS-1600-FC 934

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs69215).0427/222Communication andCare CoordinationFunctional Deficit: Change in RiskAdjusted Functional Status forPatients with Elbow, Wrist or HandImpairments:Percentage of patientsaged 18 or older that receive treatmentfor a functional deficit secondary to adiagnosis that affects the elbow, wristor hand in which the change in theirRisk-Adjusted Functional Status ismeasuredThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).FOTO X0428/223Communication andCare CoordinationFunctional Deficit: Change in RiskAdjusted Functional Status forPatients with Neck, Cranium,Mandible, Thoracic Spine, Ribs, orOther General OrthopedicImpairments:Percentage of patientsaged 18 or older that receive treatmentfor a functional deficit secondary to adiagnosis that affects the neck, cranium,mandible, thoracic spine, ribs, or otherFOTO XCMS-1600-FC 935

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsgeneral orthopedic impairment in whichthe change in their Risk-AdjustedFunctional Status is measuredThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0562/224Efficiency and CostReductionMelanoma: Overutilization ofImaging Studies in Melanoma:Percentage of patients, regardless ofage, with a current diagnosis of stage 0through IIC melanoma or a history ofmelanoma of any stage, without signsor symptoms suggesting systemicspread, seen for an office visit duringthe one-year measurement period, forwhom no diagnostic imaging studieswere orderedThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAX0509/225Communication andCare CoordinationRadiology: Reminder System forMammograms:Percentage of patientsAMA- PCPI/NCQAX XCMS-1600-FC 936

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsaged 40 years and older undergoing ascreening mammogram whoseinformation is entered into a remindersystem with a target due date for thenext mammogramThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0028/226138v2 Community/Population HealthPreventive Care and Screening:Tobacco Use: Screening andCessation Intervention:Percentage ofpatients aged 18 years and older whowere screened for tobacco use one ormore times within 24 months AND whoreceived cessation counselingintervention if identified as a tobaccouserThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA-PCPI X X X X X MU2ACOMillionHeartsN/A/228Effective Clinical CareHeart Failure (HF): Left VentricularFunction (LVF) Testing:PercentageCMS XCMS-1600-FC 937

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsof patients 18 years and older with LeftVentricular Function (LVF) testingdocumented as being performed withinthe previous 12 months or LVF testingperformed prior to discharge forpatients who are hospitalized with aprincipal diagnosis of Heart Failure(HF) during the reporting periodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/231Effective Clinical CareAsthma: Tobacco Use: Screening -Ambulatory Care Setting:Percentageof patients aged 5 through 64 years witha diagnosis of asthma (or their primarycaregiver) who were queried abouttobacco use and exposure to secondhand smoke within their homeenvironment at least once during theone-year measurement periodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FRAMA- PCPI/NCQAX X XCMS-1600-FC 938

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs69215).N/A/232Effective Clinical CareAsthma: Tobacco Use: Intervention -Ambulatory Care Setting:Percentageof patients aged 5 through 64 years witha diagnosis of asthma who wereidentified as tobacco users (or theirprimary caregiver) who receivedtobacco cessation intervention at leastonce during the one-year measurementperiodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMAPCPI/NCQAX X X0457/233Effective Clinical CareThoracic Surgery: Recording ofPerformance Status Prior to Lung orEsophageal Cancer Resection:Percentage of patients aged 18 yearsand older undergoing resection for lungor esophageal cancer for whomperformance status was documentedand reviewed within 2 weeks prior tosurgeryThis measure was finalized forSTS XCMS-1600-FC 939

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0458/234Patient SafetyThoracic Surgery: PulmonaryFunction Tests Before MajorAnatomic Lung Resection(Pneumonectomy, Lobectomy, orFormal Segmentectomy):Percentageof thoracic surgical patients aged 18years and older undergoing at least onepulmonary function test within 12months prior to a major lung resection(pneumonectomy, lobectomy, or formalsegmentectomy)This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).STS X0018/236165v2 Effective Clinical CareControlling High Blood Pressure:Percentage of patients 18-85 years ofage who had a diagnosis ofhypertension whose blood pressure wasadequately controlled (<140/90 mmHg)during the measurement period.NCQA X X X X X MU2ACOMillionHeartsCMS-1600-FC 940

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0022/238156v2 Patient SafetyUse of High-Risk Medications in theElderly:Percentage of patients 66 years ofage and older who were ordered high-riskmedications. Two rates are reported.a. Percentage of patients who wereordered at least one high-riskmedication.b. Percentage of patients who wereordered at least two different high-riskmedications.This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).NCQA X MU20024/239155v2 Community/PopulationHealthWeight Assessment and Counseling forNutrition and Physical Activity forChildren and Adolescents:Percentage ofpatients 3-17 years of age who had anoutpatient visit with a Primary CarePhysician (PCP) orObstetrician/Gynecologist (OB/GYN) andwho had evidence of the following duringthe measurement period. Three rates arereported.NCQA X MU2CMS-1600-FC 941

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs- Percentage of patients with height,weight, and body mass index (BMI)percentile documentation- Percentage of patients withcounseling for nutrition- Percentage of patients withcounseling for physical activityThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0038/240117v2 Community/PopulationHealthChildhood Immunization Status:Percentage of children 2 years of agewho had four diphtheria, tetanus andacellular pertussis (DTaP); three polio(IPV), one measles, mumps and rubella(MMR); three H influenza type B(HiB); three hepatitis B (Hep B); onechicken pox (VZV); four pneumococcalconjugate (PCV); one hepatitis A (HepA); two or three rotavirus (RV); andtwo influenza (flu) vaccines by theirsecond birthday.NCQA X MU2CMS-1600-FC 942

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0075/241182v3 Effective Clinical CareIschemic Vascular Disease (IVD):Complete Lipid Panel and LDLControl:Percentage of patients 18years of age and older who weredischarged alive for acute myocardialinfarction (AMI), coronary arterybypass graft (CABG) or percutaneouscoronary interventions (PCI) in the 12months prior to the measurementperiod, or who had an active diagnosisof ischemic vascular disease (IVD)during the measurement period, andwho had a complete lipid profileperformed during the measurementperiod and whose LDL-C wasadequately controlled (< 100 mg/dL).This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).NCQA X X X X X MU2ACOMillionHeartsN/A/ Effective Clinical CareCoronary Artery Disease (CAD):AMA- PCPI/ X XCMS-1600-FC 943

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs242Symptom Management:Percentage ofpatients aged 18 years and older with adiagnosis of coronary artery diseaseseen within a 12 month period withresults of an evaluation of level ofactivity and an assessment of whetheranginal symptoms are present or absentwith appropriate management ofanginal symptoms within a 12 monthperiodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).ACCF/AHA0643/243Effective Clinical CareCardiac Rehabilitation PatientReferral from an Outpatient Setting:Percentage of patients evaluated in anoutpatient setting who within theprevious 12 months have experiencedan acute myocardial infarction (MI),coronary artery bypass graft (CABG)surgery, a percutaneous coronaryintervention (PCI), cardiac valvesurgery, or cardiac transplantation, orwho have chronic stable angina (CSA)ACCF-AHA XCMS-1600-FC 944

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsand have not already participated in anearly outpatient cardiacrehabilitation/secondary prevention(CR) program for the qualifyingevent/diagnosis who were referred to aCR programThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AQAadopted/245Effective Clinical CareChronic Wound Care: Use of WoundSurface Culture Technique inPatients with Chronic Skin Ulcers(Overuse Measure):Percentage ofpatient visits for those patients aged 18years and older with a diagnosis ofchronic skin ulcerwithoutthe use of awound surface culture techniqueThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAX XAQAadopted/Effective Clinical CareChronic Wound Care: Use of Wet toDry Dressings in Patients withAMA- PCPI/NCQAX XCMS-1600-FC 945

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs246Chronic Skin Ulcers (OveruseMeasure):Percentage of patient visitsfor those patients aged 18 years andolder with a diagnosis of chronic skinulcerwithouta prescription orrecommendation to use wet to drydressingsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AQAadopted/247Effective Clinical CareSubstance Use Disorders: CounselingRegarding Psychosocial andPharmacologic Treatment Optionsfor Alcohol Dependence:Percentageof patients aged 18 years and older witha diagnosis of current alcoholdependence who were counseledregarding psychosocial ANDpharmacologic treatment options foralcohol dependence within the 12-month reporting periodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013AMA- PCPI/NCQAX XCMS-1600-FC 946

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsPFS Final Rule (see Table 95 at 77 FR69215).AQAadopted/248Effective Clinical CareSubstance Use Disorders: Screeningfor Depression Among Patients withSubstance Abuse or Dependence:Percentage of patients aged 18 yearsand older with a diagnosis of currentsubstance abuse or dependence whowere screened for depression within the12-month reporting periodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAX XN/A/249Effective Clinical CareBarrett's Esophagus:Percentage ofesophageal biopsy reports thatdocument the presence of Barrett’smucosa that also include a statementabout dysplasiaThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).CAP X XN/A/ Effective Clinical CareRadical Prostatectomy PathologyCAP X XCMS-1600-FC 947

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs250Reporting:Percentage of radicalprostatectomy pathology reports thatinclude the pT category, the pNcategory, the Gleason score and astatement about margin statusThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/251Effective Clinical CareImmunohistochemical (IHC)Evaluation of Human EpidermalGrowth Factor Receptor 2 Testing(HER2) for Breast Cancer Patients:This is a measure based on whetherquantitative evaluation of HumanEpidermal Growth Factor Receptor 2Testing (HER2) byimmunohistochemistry (IHC) uses thesystem recommended in theASCO/CAP Guidelines for HumanEpidermal Growth Factor Receptor 2Testing in breast cancerThis measure was finalized forinclusion in 2014 PQRS in the CY 2013CAP X XCMS-1600-FC 948

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsPFS Final Rule (see Table 95 at 77 FR69215).0651/254Effective Clinical CareUltrasound Determination ofPregnancy Location for PregnantPatients withAbdominal Pain:Percentage ofpregnant female patients aged 14 to 50who present to the emergencydepartment (ED) with a chief complaintof abdominal pain or vaginal bleedingwho receive a trans-abdominal or transvaginal ultrasound to determinepregnancy locationThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).ACEP X X0652/255Effective Clinical CareRh Immunoglobulin (Rhogam) forRh-Negative Pregnant Women atRisk of Fetal Blood Exposure:Percentage of Rh-negative pregnantwomen aged 14-50 years at risk of fetalblood exposure who receive RhImmunoglobulin (Rhogam) in theemergency department (ED)ACEP X XCMS-1600-FC 949

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/257Effective Clinical CareStatin Therapy at Discharge afterLower Extremity Bypass (LEB):Percentage of patients aged 18 yearsand older undergoing infra-inguinallower extremity bypass who areprescribed a statin medication atdischargeThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).SVS XN/A/258Communication andCare CoordinationRate of Open Repair of Small orModerate Non-Ruptured AbdominalAortic Aneurysms (AAA) withoutMajor Complications (Discharged toHome by Post-Operative Day #7):Percent of patients undergoing openrepair of small or moderate sized nonruptured abdominal aortic aneurysmswho do not experience a majorSVS XCMS-1600-FC 950

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programscomplication (discharge to home nolater than post-operative day #7)This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/259Communication andCare CoordinationRate of Endovascular AneurysmRepair (EVAR) of Small or ModerateNon-Ruptured Abdominal AorticAneurysms (AAA) without MajorComplications (Discharged to Homeby Post-Operative Day #2):Percent ofpatients undergoing endovascular repairof small or moderate non-rupturedabdominal aortic aneurysms (AAA) thatdo not experience a major complication(discharged to home no later than postoperative day #2)This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).SVS XN/A/260Communication andCare CoordinationRate of Carotid Endarterectomy(CEA) for Asymptomatic Patients,SVS XCMS-1600-FC 951

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programswithout Major Complications(Discharged to Home by PostOperative Day #2):Percent ofasymptomatic patients undergoing CEAwho are discharged to home no laterthan post-operative day #2This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/261Communication andCare CoordinationReferral for Otologic Evaluation forPatients with Acute or ChronicDizziness:Percentage of patients agedbirth and older referred to a physician(preferably a physician specially trainedin disorders of the ear) for an otologicevaluation subsequent to an audiologicevaluation after presenting with acuteor chronic dizzinessThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AQC X XN/A/ Patient SafetyImage Confirmation of SuccessfulASBS XXCMS-1600-FC 952

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs262Excision of Image–Localized BreastLesion:Image confirmation of lesion(s)targeted for image guided excisionalbiopsy or image guided partialmastectomy in patients withnonpalpable, image-detected breastlesion(s). Lesions may include:microcalcifications, mammographic orsonographic mass or architecturaldistortion, focal suspiciousabnormalities on magnetic resonanceimaging(MRI) or other breast imagingamenable to localization such aspositron emission tomography (PET)mammography, or a biopsy markerdemarcating site of confirmedpathology as established by previouscore biopsy.This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/263Effective Clinical CarePreoperative Diagnosis of BreastCancer:The percent of patientsundergoing breast cancer operationsASBS X XCMS-1600-FC 953

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programswho obtained the diagnosis of breastcancer preoperatively by a minimallyinvasive biopsy methodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/264Effective Clinical CareSentinel Lymph Node Biopsy forInvasive Breast Cancer:Thepercentage of clinically node negative(clinical stage T1N0M0 or T2N0M0)breast cancer patients who undergo asentinel lymph node (SLN) procedureThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).ASBS X0645/265Communication andCare CoordinationBiopsy Follow-Up:Percentage of newpatients whose biopsy results have beenreviewed and communicated to theprimary care/referring physician andpatient by the performing physicianThis measure was finalized forAAD XCMS-1600-FC 954

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/266Effective Clinical CareEpilepsy: Seizure Type(s) andCurrent Seizure Frequency(ies):Percentage of patient visits with adiagnosis of epilepsy who had thetype(s) of seizure(s) and current seizurefrequency(ies) for each seizure typedocumented in the medical recordThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AAN X XN/A/267Effective Clinical CareEpilepsy: Documentation of Etiologyof Epilepsy or Epilepsy Syndrome:All visits for patients with a diagnosisof epilepsy who had their etiology ofepilepsy or with epilepsy syndrome(s)reviewed and documented if known, ordocumented as unknown or cryptogenicThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FRAAN X XCMS-1600-FC 955

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs69215).N/A/268Effective Clinical CareEpilepsy: Counseling for Women ofChildbearing Potential withEpilepsy:All female patients ofchildbearing potential (12-44 years old)diagnosed with epilepsy who werecounseled about epilepsy and how itstreatment may affect contraception andpregnancy at least once a yearThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AAN X XN/A/269Effective Clinical CareInflammatory Bowel Disease (IBD):Type, Anatomic Location andActivity All Documented:Percentageof patients aged 18 years and older witha diagnosis of inflammatory boweldisease who have documented thedisease type, anatomic location andactivity, at least once during thereporting periodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013AGA XCMS-1600-FC 956

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsPFS Final Rule (see Table 95 at 77 FR69215).N/A/270Effective Clinical CareInflammatory Bowel Disease (IBD):Preventive Care: CorticosteroidSparing Therapy:Percentage ofpatients aged 18 years and older with adiagnosis of inflammatory boweldisease who have been managed bycorticosteroids greater than or equal to10 mg/day for 60 or greater consecutivedays that have been prescribedcorticosteroid sparing therapy in the lastreporting yearThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AGA XN/A/271Effective Clinical CareInflammatory Bowel Disease (IBD):Preventive Care: CorticosteroidRelatedIatrogenic Injury – Bone LossAssessment:Percentage of patientsaged 18 years and older with adiagnosis of inflammatory boweldisease who have received dose ofAGA XCMS-1600-FC 957

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programscorticosteroids greater than or equal to10 mg/day for 60 or greater consecutivedays and were assessed for risk of boneloss once per the reporting yearThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/272Effective Clinical CareInflammatory Bowel Disease (IBD):Preventive Care: InfluenzaImmunization:Percentage of patientsaged 18 years and older with adiagnosis of inflammatory boweldisease for whom influenzaimmunization was recommended,administered or previously receivedduring the reporting yearThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AGA XN/A/273Effective Clinical CareInflammatory Bowel Disease (IBD):Preventive Care: PneumococcalImmunization:Percentage of patientsAGA XCMS-1600-FC 958

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsaged 18 years and older with adiagnosis of inflammatory boweldisease that had pneumococcalvaccination administered or previouslyreceivedThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/274Effective Clinical CareInflammatory Bowel Disease (IBD):Testing for Latent Tuberculosis (TB)Before Initiating Anti-TNF (TumorNecrosis Factor) Therapy:Percentageof patients aged 18 years and older witha diagnosis of inflammatory boweldisease for whom a tuberculosis (TB)screening was performed and resultsinterpreted within 6 months prior toreceiving a first course of anti-TNF(tumor necrosis factor) therapyThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AGA XCMS-1600-FC 959

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsN/A/275Effective Clinical CareInflammatory Bowel Disease (IBD):Assessment of Hepatitis B Virus(HBV) Status Before Initiating AntiTNF (Tumor Necrosis Factor)Therapy:Percentage of patients aged18 years and older with a diagnosis ofinflammatory bowel disease who hadHepatitis B Virus (HBV) statusassessed and results interpreted within 1year prior to receiving a first course ofanti-TNF (tumor necrosis factor)therapyThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AGA XN/A/276Effective Clinical CareSleep Apnea: Assessment of SleepSymptoms:Percentage of visits forpatients aged 18 years and older with adiagnosis of obstructive sleep apneathat includes documentation of anassessment of sleep symptoms,including presence or absence ofsnoring and daytime sleepinessAMA- PCPI/NCQAXCMS-1600-FC 960

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/277Effective Clinical CareSleep Apnea: Severity Assessment atInitial Diagnosis:Percentage ofpatients aged 18 years and older with adiagnosis of obstructive sleep apneawho had an apnea hypopnea index(AHI) or a respiratory disturbanceindex (RDI) measured at the time ofinitial diagnosisThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAXN/A/278Effective Clinical CareSleep Apnea: Positive AirwayPressure Therapy Prescribed:Percentage of patients aged 18 yearsand older with a diagnosis of moderateor severe obstructive sleep apnea whowere prescribed positive airwaypressure therapyThis measure was finalized forAMA- PCPI/NCQAXCMS-1600-FC 961

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/279Effective Clinical CareSleep Apnea: Assessment ofAdherence to Positive AirwayPressure Therapy:Percentage of visitsfor patients aged 18 years and olderwith a diagnosis of obstructive sleepapnea who were prescribed positiveairway pressure therapy who haddocumentation that adherence topositive airway pressure therapy wasobjectively measuredThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA- PCPI/NCQAXN/A/280Communication andCare CoordinationDementia: Staging of Dementia:Percentage of patients, regardless ofage, with a diagnosis of dementiawhose severity of dementia wasclassified as mild, moderate or severe atleast once within a 12 month periodThis measure was finalized forAMA-PCPI XCMS-1600-FC 962

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/281149v2 Effective Clinical CareDementia: Cognitive Assessment:Percentage of patients, regardless ofage, with a diagnosis of dementia forwhom an assessment of cognition isperformed and the results reviewed atleast once within a 12 month period*The EHR-based reporting option isavailable for reporting this measurebeginning in 2014.*In an effort to align with the EHRIncentive Program, this measure will bereportable via EHR beginning in 2014.The alignment of measures containedwithin multiple CMS reportingprograms eases the burden of reportingand encourages eligible professionals tosubmit quality clinical data on careprovided for Medicare beneficiaries.Alignment also promotes a robust datasource and consistency in analysis,which supports other quality programsAMA-PCPI X X MU2CMS-1600-FC 963

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programswithin CMS. For these reasons, we arefinalizing the addition of the EHRbased reporting option for this measurebeginning in 2014.N/A/282Effective Clinical CareDementia: Functional StatusAssessment:Percentage of patients,regardless of age, with a diagnosis ofdementia for whom an assessment ofpatient’s functional status is performedand the results reviewed at least oncewithin a 12 month periodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA-PCPI XN/A/283Effective Clinical CareDementia: NeuropsychiatricSymptom Assessment:Percentage ofpatients, regardless of age, with adiagnosis of dementia and for whom anassessment of patient’sneuropsychiatric symptoms isperformed and results reviewed at leastonce in a 12 month periodThis measure was finalized forAMA-PCPI XCMS-1600-FC 964

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/284Effective Clinical CareDementia: Management ofNeuropsychiatric Symptoms:Percentage of patients, regardless ofage, with a diagnosis of dementia whohave one or more neuropsychiatricsymptoms who received or wererecommended to receive an interventionfor neuropsychiatric symptoms within a12 month periodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA-PCPI XN/A/285Effective Clinical CareDementia: Screening for DepressiveSymptoms:Percentage of patients,regardless of age, with a diagnosis ofdementia who were screened fordepressive symptoms within a 12month periodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013AMA-PCPI XCMS-1600-FC 965

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsPFS Final Rule (see Table 95 at 77 FR69215).N/A/286Patient SafetyDementia: Counseling RegardingSafety Concerns:Percentage ofpatients, regardless of age, with adiagnosis of dementia or theircaregiver(s) who were counseled orreferred for counseling regarding safetyconcerns within a 12 month periodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA-PCPI XN/A/287Effective Clinical CareDementia: Counseling RegardingRisks of Driving:Percentage ofpatients, regardless of age, with adiagnosis of dementia or theircaregiver(s) who were counseledregarding the risks of driving and thealternatives to driving at least oncewithin a 12 month periodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FRAMA-PCPI XCMS-1600-FC 966

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs69215).N/A/288Effective Clinical CareDementia: Caregiver Education andSupport:Percentage of patients,regardless of age, with a diagnosis ofdementia whose caregiver(s) wereprovided with education on dementiadisease management and healthbehavior AND referred to additionalsources for support within a 12 monthperiodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA-PCPI XN/A/289Effective Clinical CareParkinson’s Disease: AnnualParkinson’s Disease DiagnosisReview:All patients with a diagnosisof Parkinson’s disease who had anannual assessment including a reviewof current medications (e.g.,medications than can produceParkinson-like signs or symptoms) anda review for the presence of atypicalfeatures (e.g., falls at presentation andearly in the disease course, poorAAN XCMS-1600-FC 967

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsresponse to levodopa, symmetry atonset, rapid progression [to Hoehn andYahr stage 3 in 3 years], lack of tremoror dysautonomia) at least annuallyThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/290Effective Clinical CareParkinson’s Disease: PsychiatricDisorders or DisturbancesAssessment:All patients with adiagnosis of Parkinson’s disease whowere assessed for psychiatric disordersor disturbances (e.g., psychosis,depression, anxiety disorder, apathy, orimpulse control disorder) at leastannuallyThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AAN XN/A/291Effective Clinical CareParkinson’s Disease: CognitiveImpairment or DysfunctionAssessment:All patients with aAAN XCMS-1600-FC 968

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsdiagnosis of Parkinson’s disease whowere assessed for cognitive impairmentor dysfunction at least annuallyThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/292Effective Clinical CareParkinson’s Disease: Querying aboutSleep Disturbances:All patients with adiagnosis of Parkinson’s disease (orcaregivers, as appropriate) who werequeried about sleep disturbances at leastannuallyThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AAN XN/A/293Effective Clinical CareParkinson’s Disease: RehabilitativeTherapy Options:All patients with adiagnosis of Parkinson’s disease (orcaregiver(s), as appropriate) who hadrehabilitative therapy options (e.g.,physical, occupational, or speechtherapy) discussed at least annuallyAAN XCMS-1600-FC 969

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/294Effective Clinical CareParkinson’s Disease: Parkinson’sDisease Medical and SurgicalTreatment Options Reviewed:Allpatients with a diagnosis of Parkinson’sdisease (or caregiver(s), as appropriatewho had the Parkinson’s diseasetreatment options (e.g., nonpharmacological treatment,pharmacological treatment, or surgicaltreatment) reviewed at least onceannuallyThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AAN XN/A/295Effective Clinical CareHypertension: Use of Aspirin orOther Antithrombotic Therapy:Percentage of patients aged 30 through90 years old with a diagnosis ofhypertension and are eligible for aspirinABIM XCMS-1600-FC 970

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsor other antithrombotic therapy whowere prescribed aspirin or otherantithrombotic therapyThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/296Effective Clinical CareHypertension: Complete LipidProfile:Percentage of patients aged 18through 90 years old with a diagnosis ofhypertension who received a completelipid profile within60 monthsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).ABIM XN/A/297Effective Clinical CareHypertension: Urine Protein Test:Percentage of patients aged 18 through90 years old with a diagnosis ofhypertension who either have chronickidney disease diagnosis documented orhad a urine protein test done within36monthsABIM XCMS-1600-FC 971

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/298Effective Clinical CareHypertension: Annual SerumCreatinine Test:Percentage of patientsaged 18 through 90 years old with adiagnosis of hypertension who had aserum creatinine test done within12monthsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).ABIM XN/A/299Effective Clinical CareHypertension: Diabetes MellitusScreening Test:Percentage of patientsaged 18 through 90 years old with adiagnosis of hypertension who had adiabetes screening test within36monthsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).ABIM XCMS-1600-FC 972

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsN/A/300Effective Clinical CareHypertension: Blood PressureControl:Percentage of patients aged18 through 90 years old with adiagnosis of hypertension whose mostrecent blood pressure was under control(< 140/90 mmHg)This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).ABIM XN/A/301Effective Clinical CareHypertension: Low DensityLipoprotein (LDL-C) Control:Percentage of patients aged 18 through90 years old with a diagnosis ofhypertension whose most recent LDLcholesterol level was under control (atgoal)This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).ABIM XN/A/302Effective Clinical CareHypertension: Dietary and PhysicalActivity Modifications AppropriatelyPrescribed:Percentage of patientsABIM XCMS-1600-FC 973

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsaged 18 through 90 years old with adiagnosis of hypertension who receiveddietary and physical activity counselingat least once within12 monthsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/303Effective Clinical CareCataracts: Improvement in Patient’sVisual Function within 90 DaysFollowing Cataract Surgery:Percentage of patients aged 18 yearsand older in sample who had cataractsurgery and had improvement in visualfunction achieved within 90 daysfollowing the cataract surgery, based oncompleting a pre-operative and postoperative visual function surveyThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AAO X XN/A/304Person and CaregiverCentered ExperienceCataracts: Patient Satisfaction within90 Days Following Cataract Surgery:AAO X XCMS-1600-FC 974

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsand OutcomesPercentage of patients aged 18 yearsand older in sample who had cataractsurgery and were satisfied with theircare within 90 days following thecataract surgery, based on completionof the Consumer Assessment ofHealthcare Providers and SystemsSurgical Care SurveyThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0004/305137v2 Effective Clinical CareInitiation and Engagement of Alcoholand Other Drug Dependence Treatment:Percentage of patients 13 years of age andolder with a new episode of alcohol andother drug (AOD) dependence whoreceived the following. Two rates arereported.a. Percentage of patients who initiatedtreatment within 14 days of thediagnosis.b. Percentage of patients who initiatedtreatment and who had two or moreadditional services with an AODdiagnosis within 30 days of theinitiation visit.NCQA X MU2CMS-1600-FC 975

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0032/309124v2 Effective Clinical CareCervical Cancer Screening:Percentage of women 21-64 years ofage, who received one or more Pap teststo screen for cervical cancer.This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).NCQA X MU20033/310153v2 Community/Population HealthChlamydia Screening for Women:Percentage of women 16-24 years of agewho were identified as sexually active andwho had at least one test for chlamydiaduring the measurement periodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).NCQA X MU20036/311126v2 Effective Clinical CareUse of Appropriate Medications forAsthma:Percentage of patients 5-64 yearsof age who were identified as havingpersistent asthma and were appropriatelyNCQA X MU2CMS-1600-FC 976

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsprescribed medication during themeasurement periodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0052/312166v3 Efficiency and CostReductionUse of Imaging Studies for Low BackPain:Percentage of patients 18-50years of age with a diagnosis of lowback pain who did not have an imagingstudy (plain X-ray, MRI, CT scan)within 28 days of the diagnosis.This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).NCQA X MU2N/A/31661v3and64v3Effective Clinical CarePreventive Care and Screening:Cholesterol – Fasting Low DensityLipoprotein (LDL-C) Test PerformedAND Risk-Stratified Fasting LDL-C:Percentage of patients aged 20 through79 years whose risk factors* have beenassessed and a fasting LDL test hasbeen performed AND percentage ofpatients aged 20 through 79 years whohad a fasting LDL-C test performed andCMS X MU2MillionHeartsCMS-1600-FC 977

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programswhose risk-stratified fasting LDL-C isat or below the recommended LDL-Cgoal.*There are three criteria for thismeasure based on the patient’s riskcategory.1. Highest Level of Risk: CoronaryHeart Disease (CHD) or CHD RiskEquivalent OR 10-Year FraminghamRisk >20%2. Moderate Level of Risk: Multiple(2+) Risk Factors OR 10-YearFramingham Risk 10-20%3. Lowest Level of Risk: 0 or 1 RiskFactor OR 10-Year Framingham Risk<10%This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/31722v2 Community/Population HealthPreventive Care and Screening:Screening for High Blood Pressureand Follow-Up Documented:Percentage of patients aged 18 yearsand older seen during the reportingCMS X X X X X MU2ACOMillionHeartsCMS-1600-FC 978

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsperiod who were screened for highblood pressure AND a recommendedfollow-up plan is documented based onthe current blood pressure (BP) readingas indicatedThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0101/318139v2 Patient SafetyFalls: Screening for Future Fall Risk:Percentage of patients 65 years of ageand older who were screened for futurefall risk during the measurement period.*The EHR-based reporting option isavailable for reporting this measurebeginning in 2014.*In an effort to align with the EHRIncentive Program, this measure will bereportable via EHR beginning in 2014.The alignment of measures containedwithin multiple CMS reportingprograms eases the burden of reportingand encourages eligible professionals toNCQA X X MU2ACOCMS-1600-FC 979

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programssubmit quality clinical data on careprovided for Medicare beneficiaries.Alignment also promotes a robust datasource and consistency in analysis,which supports other quality programswithin CMS. For these reasons, we arefinalizing the addition of the EHRbased reporting option for this measurebeginning in 2014.0729/319Effective Clinical CareDiabetes Composite: OptimalDiabetes Care:Patients ages 18through 75 with a diagnosis of diabetes,who meet all the numerator targets ofthis composite measure:•A1c < 8.0%,•LDL < 100 mg/dL,•blood pressure < 140/90 mmHg,•tobacco non-user and•for patients with a diagnosis ofischemic vascular disease dailyaspirin use unless contraindicatedThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).MNCM X ACO0658/320Communication andCare CoordinationEndoscopy/Polyp Surveillance:Appropriate Follow-Up Interval forAMA-PCPI X XCMS-1600-FC 980

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsNormal Colonoscopy in Average RiskPatients:Percentage of patients aged50 years and older receiving a screeningcolonoscopy without biopsy orpolypectomy who had a recommendedfollow-up interval of at least 10 yearsfor repeat colonoscopy documented intheir colonoscopy reportThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0005&0006/321Communication andCare CoordinationCG-CAHPS Clinician/Group Survey•Getting timely care,appointments,and information;•How well providersCommunicate;•Patient’s Rating of Provider;•Access to Specialists;•Health Promotion & Education;•Shared Decision Making;•Health Status/FunctionalStatus;•Courteous and Helpful OfficeStaff;•Care Coordination;•Between Visit Communication;ASPE X ACOCMS-1600-FC 981

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs•Helping Your to Take Medicationas Directed; and•Stewardship of Patient ResourcesThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).0670/322Efficiency and CostReductionCardiac Stress Imaging Not MeetingAppropriate Use Criteria:Preoperative Evaluation in Low-RiskSurgery Patients:Percentage of stresssingle-photon emission computedtomography (SPECT) myocardialperfusion imaging (MPI), stressechocardiogram (ECHO), cardiaccomputed tomography angiography(CCTA), or cardiac magnetic resonance(CMR) performed in low risk surgerypatients 18 years or older forpreoperative evaluation during the 12-month reporting periodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FRACC XCMS-1600-FC 982

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs69215).0671/323Efficiency and CostReductionCardiac Stress Imaging Not MeetingAppropriate Use Criteria: RoutineTesting After Percutaneous CoronaryIntervention (PCI):Percentage of allstress single-photon emission computedtomography (SPECT) myocardial perfusionimaging (MPI), stress echocardiogram(ECHO), cardiac computed tomographyangiography (CCTA), and cardiovascularmagnetic resonance (CMR) performed inpatients aged 18 years and older routinelyafter percutaneous coronary intervention(PCI), with reference to timing of test afterPCI and symptom statusThis measure was finalized for inclusion in2014 PQRS in the CY 2013 PFS Final Rule(see Table 95 at 77 FR 69215).ACC X0672/324Efficiency and CostReductionCardiac Stress Imaging Not MeetingAppropriate Use Criteria: Testing inAsymptomatic, Low-Risk Patients:Percentage of all stress single-photonemission computed tomography(SPECT) myocardial perfusion imaging(MPI), stress echocardiogram (ECHO),cardiac computed tomographyangiography (CCTA), andcardiovascular magnetic resonance(CMR) performed in asymptomatic,ACC XCMS-1600-FC 983

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programslow coronary heart disease (CHD) riskpatients 18 years and older for initialdetection and risk assessmentThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).N/A/325Effective Clinical CareAdult Major Depressive Disorder(MDD): Coordination of Care ofPatients with Specific ComorbidConditions:Percentage of medicalrecords of patients aged 18 years andolder with a diagnosis of majordepressive disorder (MDD) and aspecific diagnosed comorbid condition(diabetes, coronary artery disease,ischemic stroke, intracranialhemorrhage, chronic kidney disease[stages 4 or 5], End Stage RenalDisease [ESRD] or congestive heartfailure) being treated by anotherclinician with communication to theclinician treating the comorbidconditionAMA-PCPI XCMS-1600-FC 984

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).1525/326Patient SafetyAtrial Fibrillation and Atrial Flutter:Chronic Anticoagulation Therapy:Percentage of patients aged 18 yearsand older with a diagnosis ofnonvalvular atrial fibrillation (AF) oratrial flutter whose assessment of thespecified thromboembolic risk factorsindicate one or more high-risk factorsor more than one moderate risk factor,as determined by CHADS2 riskstratification, who are prescribedwarfarin OR another oral anticoagulantdrug that is FDA approved for theprevention of thromboembolismThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).AMA-PCPI/ACCF/AHAX XN/A/327Effective Clinical CarePediatric Kidney Disease: Adequacyof Volume Management:Percentageof calendar months within a 12-monthAMA X XCMS-1600-FC 985

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsperiod during which patients aged 17years and younger with a diagnosis ofEnd Stage Renal Disease (ESRD)undergoing maintenance hemodialysisin an outpatient dialysis facility have anassessment of the adequacy of volumemanagement from a nephrologistThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FR69215).1667/328Effective Clinical CarePediatric Kidney Disease: ESRDPatients Receiving Dialysis:Hemoglobin Level < 10 g/dL:Percentage of calendar months within a12-month period during which patientsaged 17 years and younger with adiagnosis of End Stage Renal Disease(ESRD) receiving hemodialysis orperitoneal dialysis have a hemoglobinlevel < 10 g/dLThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule (see Table 95 at 77 FRAMA-PCPI X XCMS-1600-FC 986

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programs69215).N/A/N/A‡Effective Clinical CareAdult Kidney Disease: Catheter Useat Initiation of Hemodialysis:Percentage of patients aged 18 yearsand older with a diagnosis of End StageRenal Disease (ESRD) who initiatemaintenance hemodialysis during themeasurement period, whose mode ofvascular access is a catheter at the timemaintenance hemodialysis is initiatedSeveral commenters supported theinclusion of this measure, statingcatheter use is the primary contributingfactor to bloodstream infections inhemodialysis patients. We appreciatethe commenters’ feedback and believethis measure will help deter the use ofcatheters for hemodialysis patients.Additionally, this measure expandsupon the care that is represented inadult kidney disease patient population.It allows eligible professionalsproviding care for these patients agreater variety of measures to report.For the reasons previously stated, weAMA-PCPI XCMS-1600-FC 987

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsfinalizing this individual measure forreporting beginning in 2014.N/A/N/A‡Effective Clinical CareAdult Kidney Disease: Catheter Usefor Greater Than or Equal to 90Days:Percentage of patients aged 18years and older with a diagnosis of EndStage Renal Disease (ESRD) receivingmaintenance hemodialysis for greaterthan or equal to 90 days whose mode ofvascular access is a catheterSeveral commenters supported theinclusion of this measure,statingphysician referrals for appropriatevascular access placement in patientswho will soon need dialysis and whoare already on dialysis, are important toreducing the use of catheters inhemodialysis patients. We agree withthe commenters’ feedback this measureexpands upon the care that isrepresented in adult kidney diseasepatient population. Additionally, itallows eligible professionals providingcare for these patients a greater varietyof measures to report. For the reasonsAMA-PCPI XCMS-1600-FC 988

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programspreviously stated, we finalizing thisindividual measure for reportingbeginning in 2014.N/A/N/A‡Effective Clinical CareAdult Sinusitis: Antibiotic Prescribedfor Acute Sinusitis (AppropriateUse):Percentage of patients, aged 18years and older, with a diagnosis ofacute sinusitis who were prescribed anantibiotic within 7 days of diagnosis orwithin 10 days after onset of symptomsSeveral commenters supported theinclusion of this measure.Onecommenter requested clarification as towhy this measure has been included forregistry-only reporting, despite requeststhat it also be included for EHR-basedreporting. In an effort to streamline thereporting options available under thePQRS and to eliminate reportingoptions that are not widely used, allnew measures incorporated in PQRSare available via registry-only.Additionally, for CY 2014, CMS wasunable to determine the feasibility ofincorporation of this measure for otherAMA-PCPI XCMS-1600-FC 989

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsreporting options; however, CMSintends to continue working towardcomplete alignment of measurespecifications across programswhenever possible and incorporation ofthis measure for EHR-based reportingmay be considered in the future.This measure represents a new medicalconcept and fills a gap in care notpreviously addressed by the PQRS. Themeasure is reportable by Ear, Nose andThroat (ENT) and other eligibleprofessionals within this specific scopeof practice that previously had a limitednumber of measures available forreporting within PQRS. For thesereasons, we are finalizing this measurefor registry-based reporting beginningin 2014.N/A/N/A‡Effective Clinical CareAdult Sinusitis: Appropriate Choiceof Antibiotic: Amoxicillin Prescribedfor Patients with Acute BacterialSinusitis:Percentage of patients aged18 years and older with a diagnosis ofacute bacterial sinusitis that wereAMA-PCPI XCMS-1600-FC 990

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsprescribed amoxicillin, withoutclavulante, as a first line antibiotic atthe time of diagnosisSeveral commenters expressed generalsupport for the inclusion of thismeasure.One commenter requestedclarification as to why this measure hasbeen included for registry-onlyreporting, despite requests that it alsobe included for EHR-based reporting.In an effort to streamline the reportingoptions available under the PQRS andto eliminate reporting options that arenot widely used, all new measuresincorporated in PQRS are available viaregistry-only. Additionally, for CY2014, CMS was unable to determine thefeasibility of incorporation of thismeasure for other reporting options;however, CMS intends to continueworking toward complete alignment ofmeasure specifications across programswhenever possible and incorporation ofthis measure for EHR-based reportingmay be considered in the future.CMS-1600-FC 991

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsThis measure represents a new medicalconcept and fills a gap in care notpreviously addressed by the PQRS. Themeasure is reportable by Ear, Nose andThroat (ENT) and other eligibleprofessionals within this specific scopeof practice that previously had a limitednumber of measures available forreporting within PQRS. For thesereasons, we are finalizing this measurefor registry-based reporting beginningin 2014.N/A/N/A‡Efficiency and CostReductionAdult Sinusitis: ComputerizedTomography for Acute Sinusitis(Overuse):Percentage of patients aged18 years and older with a diagnosis ofacute sinusitis who had a computerizedtomography (CT) scan of the paranasalsinuses ordered at the time of diagnosisor received within 28 days after date ofdiagnosisSeveral commenters supported theinclusion of this measure.Onecommenter requested clarification as toAMA-PCPI XCMS-1600-FC 992

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programswhy this measure has been included forregistry-only reporting, despite requeststhat it also be included for EHR-basedreporting. In an effort to streamline thereporting options available under thePQRS and to eliminate reportingoptions that are not widely used, allnew measures incorporated in PQRSare available via registry-only.Additionally, for CY 2014, CMS wasunable to determine the feasibility ofincorporation of this measure for otherreporting options; however, CMSintends to continue working towardcomplete alignment of measurespecifications across programswhenever possible and incorporation ofthis measure for EHR-based reportingmay be considered in the future.This measure represents a new medicalconcept and fills a gap in care notpreviously addressed by the PQRS. Themeasure is reportable by Ear, Nose andThroat (ENT) and other eligibleCMS-1600-FC 993

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsprofessionals within this specific scopeof practice that previously had a limitednumber of measures available forreporting within PQRS. For thesereasons, we are finalizing this measurefor registry-based reporting beginningin 2014.N/A/N/A‡Efficiency and CostReductionAdult Sinusitis: More than OneComputerized Tomography (CT)Scan Within 90 Days for ChronicSinusitis (Overuse):Percentage ofpatients aged 18 years and older with adiagnosis of chronic sinusitis who hadmore than one CT scan of the paranasalsinuses ordered or received within 90days after the date of diagnosisSeveral commenters expressed generalsupport for the inclusion of thismeasure.One commenter requestedclarification as to why this measure hasbeen included for registry-onlyreporting, despite requests that it alsobe included for EHR-based reporting.In an effort to streamline the reportingoptions available under the PQRS andAMA-PCPI XCMS-1600-FC 994

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsto eliminate reporting options that arenot widely used, all new measuresincorporated in PQRS are available viaregistry-only.Additionally, for CY 2014, CMS wasunable to determine the feasibility ofincorporation of this measure for otherreporting options; however, CMSintends to continue working towardcomplete alignment of measurespecifications across programswhenever possible and incorporation ofthis measure for EHR-based reportingmay be considered in the future.This measure represents a new medicalconcept and fills a gap in care notpreviously addressed by the PQRS. Themeasure is reportable by Ear, Nose andThroat (ENT) and other eligibleprofessionals within this specific scopeof practice that previously had a limitednumber of measures available forreporting within PQRS. For thesereasons, we are finalizing this measureCMS-1600-FC 995

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsfor registry-based reporting beginningin 2014.N/A/N/A‡Patient SafetyMaternity Care: Elective Delivery orEarly Induction Without MedicalIndication at≥37 and < 39 Weeks:Percentage of patients, regardless ofage, who gave birth during a 12-monthperiod who delivered a live singleton at≥37 and < 39 weeks of gestationcompleted who had elective deliveriesor early inductions without medicalindicationOne commenter expressed generalsupport for the inclusion of thismeasure and proposed it be adopted forEHR reporting in the future. Weappreciate the commenter’s support ofthis measure. For CY 2014, CMS wasunable to determine the feasibility ofincorporation of this measure for otherreporting options; however, CMSintends to continue working towardcomplete alignment of measurespecifications across programswhenever possible and incorporation ofAMA-PCPI XCMS-1600-FC 996

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsthis measure for EHR-based reportingmay be considered in the future.This measure represents a new medicalconcept within PQRS, reportable byObstetrics/Gynecologist and othereligible professionals within thisspecific scope of practice whopreviously had a limited number ofmeasures available for reporting. Forthese reasons, we are finalizing thismeasure for registry-based reportingbeginning in 2014.N/A/N/A‡Communication andCare CoordinationMaternity Care: Post-PartumFollow-Up and Care Coordination:Percentage of patients, regardless ofage, who gave birth during a 12-monthperiod who were seen for post-partumcare within 8 weeks of giving birth whoreceived a breast feeding evaluation andeducation, post-partum depressionscreening, post-partum glucosescreening for gestational diabetespatients, and family and contraceptiveplanningAMA-PCPI XCMS-1600-FC 997

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsOne commenter expressed generalsupport for the inclusion of thismeasure and proposed it be adopted forEHR reporting in the future. Weappreciate the commenter’s support ofthis measure. For CY 2014, CMS wasunable to determine the feasibility ofincorporation of this measure for otherreporting options; however, CMSintends to continue working towardcomplete alignment of measurespecifications across programswhenever possible and incorporation ofthis measure for EHR-based reportingmay be considered in the future.This measure represents a new medicalconcept within PQRS, reportable byObstetrics/Gynecologist and othereligible professionals within thisspecific scope of practice whopreviously had a limited number ofmeasures available for reporting. Forthese reasons, we are finalizing thismeasure for registry-based reportingbeginning in 2014.CMS-1600-FC 998

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsN/A/N/A‡Effective Clinical CareTuberculosis Prevention for Psoriasisand Psoriatic Arthritis Patients on aBiological Immune ResponseModifier:Percentage of patients whoseproviders are ensuring activetuberculosis prevention either throughyearly negative standard tuberculosisscreening tests or are reviewing thepatient’s history to determine if theyhave had appropriate management for arecent or prior positive testOne commenter expressed generalsupport for the inclusion of thismeasure. We appreciate thecommenters’ feedback.Psoriasis is a new medical concept forreporting within PQRS and fills a gapin care not previously addressed by thePQRS. This measure would provideDermatology and other related eligibleprofessionals an additional measure toreport within PQRS. This measurecould also be reported by otherprofessionals that treat joint care, suchAAD XCMS-1600-FC 999

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsas Family Practice andRheumatologists. For these reasons, weare finalizing this measure for reportingbeginning in 2014.2082/N/A‡Effective Clinical CareHIV Viral Load Suppression:Thepercentage of patients, regardless ofage, with a diagnosis of HIV with aHIV viral load less than 200 copies/mLat last HIV viral load test during themeasurement yearThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.HRSA X X2083/N/A‡Effective Clinical CarePrescription of HIV AntiretroviralTherapy:Percentage of patients,regardless of age, with a diagnosis ofHIV prescribed antiretroviral therapyfor the treatment of HIV infectionduring the measurement yearThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.HRSA X XN/A/2079‡Efficiency and CostReductionHIV Medical Visit Frequency:Percentage of patients, regardless of ageHRSA XCMS-1600-FC 1000

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programswith a diagnosis of HIV who had atleast one medical visit in each 6 monthperiod of the 24 month measurementperiod, with a minimum of 60 daysbetween medical visitsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.N/A/2080‡Efficiency and CostReductionGap in HIV Medical Visits:Percentage of patients, regardless ofage, with a diagnosis of HIV who didnot have a medical visit in the last 6monthsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.HRSA X0209/N/A‡Person and CaregiverCentered Experienceand OutcomesPain Brought Under Control Within48 Hours:Patients aged 18 and olderwho report being uncomfortablebecause of pain atthe initial assessment(after admission to palliative careservices) who report pain was broughtto a comfortable level within 48 hoursNHPCO XCMS-1600-FC 1001

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsOne commenter expressed generalsupport for the inclusion of thismeasure. We appreciate thecommenter’s support.Previously, there were no measureswithin the PQRS that addressed care forpatients being managed by palliativecare or eligible professionals that wouldprovide these services to patients. Painmanagement for patients receivingpalliative care will provide beneficialdata for this medical concept. For thesereasons, we are finalizing this measurefor inclusion in PQRS beginning in2014.N/A/N/A‡Effective Clinical CareScreening Colonoscopy AdenomaDetection Rate Measure:Thepercentage of patients age 50 years orolder with at least one adenoma or othercolorectal cancer precursor or colorectalcancer detected during screeningcolonoscopyOne commenter agreed with CMS thatthis measure, along with other existingACG/ASGEXCMS-1600-FC 1002

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsPQRS colonoscopy measures, is vital toimproving patient outcomes. Anothercommenter supported the inclusion ofthis measure but was concerned that itwas proposed for registry-onlyreporting.In an effort to streamline the reportingoptions available under the PQRS andto eliminate reporting options that arenot widely used, all new measuresincorporated in PQRS are available viaregistry-only.Additionally, for CY 2014, CMS wasunable to determine the feasibility ofincorporation of this measure for otherreporting options; however, CMSintends to continue working towardcomplete alignment of measurespecifications across programswhenever possible and incorporation ofthis measure in other PQRS reportingoptions may considered in the future.This measure addresses a broad patientCMS-1600-FC 1003

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programspopulation for screening and detectionof colorectal cancer and is medicallysignificant in the measurement ofutilizing preventive healthcareservices.. For this reason, we arefinalizing this individual measure forregistry reporting beginning in 2014.N/A/N/A‡Effective Clinical CareRate of Carotid Artery Stenting(CAS) for Asymptomatic Patients,Without Major Complications(Discharged to Home by PostOperative Day #2):Percent ofasymptomatic patients undergoing CASwho are discharged to home no laterthan post-operative day #2Several commenters expressed generalsupport for the inclusion of thismeasure in PQRS beginning in 2014.We appreciate the commenters’ supportAdditionally, this measure providesopportunity for Vascular Surgicaleligible professionals to report a greaternumber of measures. CMS’ goal is toprovide ample reporting opportunitiesSVS XCMS-1600-FC 1004

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsto eligible professionals, especiallythose who are unable to report otherbroadly applicable measures. For thisreason, we are finalizing this measurefor inclusion in PQRS beginning in2014.N/A/N/A‡Effective Clinical CareRate of Postoperative Stroke orDeath in Asymptomatic PatientsUndergoing Carotid Artery Stenting(CAS):Percent of asymptomaticpatients undergoing CAS whoexperience stroke or death followingsurgery while in the hospitalSeveral commenters expressed generalsupport for the inclusion of thismeasure in 2014 PQRS. Onecommenter supported the inclusion ofthis measure but was concerned that itwas proposed for registry-onlyreporting. In an effort to streamline thereporting options available under thePQRS and to eliminate reportingoptions that are not widely used, allnew measures incorporated in PQRSare available via registry-only.SVS XCMS-1600-FC 1005

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsAdditionally, for CY 2014, CMS wasunable to determine the feasibility ofincorporation of this measure for otherreporting options; however, CMSintends to continue working towardcomplete alignment of measurespecifications across programswhenever possible and incorporation ofthis measure in other PQRS reportingoptions may considered in the future.This measure provides opportunity forVascular Surgical eligible professionalsto report a greater number of measures.CMS’ goal is to provide amplereporting opportunities to eligibleprofessionals, especially those who areunable to report other broadlyapplicable measures. For this reason,we are finalizing this measure forinclusion in PQRS beginning in 2014.N/A/N/A‡Effective Clinical CareRate of Postoperative Stroke orDeath in Asymptomatic Patientsundergoing CarotidEndarterectomy (CEA):Percent ofSVS XCMS-1600-FC 1006

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsasymptomatic patients undergoing CEAwho experience stroke or deathfollowing surgery while in the hospitalSeveral commenters expressed generalsupport for the inclusion of thismeasure in 2014 PQRS. Onecommenter supported the inclusion ofthis measure but was concerned that itwas proposed for registry-onlyreporting. In an effort to streamline thereporting options available under thePQRS and to eliminate reportingoptions that are not widely used, allnew measures incorporated in PQRSare available via registry-only.Additionally, for CY 2014, CMS wasunable to determine the feasibility ofincorporation of this measure for otherreporting options; however, CMSintends to continue working towardcomplete alignment of measurespecifications across programswhenever possible and incorporation ofthis measure in other PQRS reportingCMS-1600-FC 1007

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsoptions may considered in the future.This measure provides opportunity forVascular Surgical eligible professionalsto report a greater number of measures.CMS’ goal is to provide amplereporting opportunities to eligibleprofessionals, especially those who areunable to report other broadlyapplicable measures. For this reason,we are finalizing this measure forinclusion in PQRS beginning in 2014.N/A/N/A‡Effective Clinical CareRate of Endovascular AneurysmRepair (EVAR) of Small or ModerateNon-Ruptured Abdominal AorticAneurysms (AAA) Who Die While inHospital:Percent of patientsundergoing endovascular repair ofsmall or moderate abdominal aorticaneurysms (AAA) who die while in thehospitalSeveral commenters expressed generalsupport for the inclusion of thismeasure. We appreciate thecommenters’ feedback.SVS XCMS-1600-FC 1008

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsThis measure provides opportunity forVascular Surgical eligible professionalsto report a greater number of measures.CMS’ goal is to provide amplereporting opportunities to eligibleprofessionals, especially those who areunable to report other broadlyapplicable measures. For this reason,we are finalizing this measure forinclusion in PQRS beginning in 2014.N/A/N/A‡Effective Clinical CareHRS-3: Implantable CardioverterDefibrillator (ICD) ComplicationsRate:Patients with physician-specificrisk-standardized rates of proceduralcomplications following the first timeimplantation of an ICDSeveral commenters supported theinclusion of this measure in 2014 PQRSas it has the potential to significantlyimprove the quality of care delivered topatients with advanced heart disease.One commenter also expressed supportfor including this measure for registrybased reporting, stating the riskHRS XCMS-1600-FC 1009

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsadjustment in this measure includes anumber of data elements that could notbe found in claims data. We appreciatethe commenters’ support.This measure provides opportunity forElectrophysiologists and other eligibleprofessionals within this scope ofpractice to report a greater number ofmeasures. CMS’ goal is to provideample reporting opportunities toeligible professionals, especially thosewho may be unable to report otherbroadly applicable measures. For thisreason, we are finalizing this measurefor inclusion in PQRS beginning in2014.N/A/N/A‡Effective Clinical CareOptimal Vascular Composite:Percentof patients aged 18 to 75 with ischemicvascular disease (IVD) who haveoptimally managed modifiable riskfactors demonstrated by meeting all ofthe numerator targets of this patientlevel all-or-none composite measure:LDL less than 100, blood pressure lessthan 140/90, tobacco-free status, andMNCM XCMS-1600-FC 1010

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsdaily aspirin useOne commenter provided generalsupport for this measure but opposed itsuse due to its target population andemphasis on numerical value targets asnumerical targets as they believenumerical targets provide an incentiveto treat tests rather than symptoms. Werespectfully disagree, as this compositeencompasses measurements thataddress risk factors for the specificpatient population diagnosed withvascular disease. Addressing riskfactors with treatment such asantiplatelet therapy and assessing bloodpressure, lipid control and smokingwithin this patient population arecommon annual assessments andtreatment for patients diagnosed withvascular disease. Management of bloodpressure and lipids and encouragingpatients to avoid smoking and maintainan antiplatelet treatment is beneficialfor this patient population.Additionally, it is reportable by aCMS-1600-FC 1011

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsvariety of eligible professionals.Therefore, we are finalizing thismeasure for inclusion in PQRSbeginning in 2014.N/A/N/A‡Communication andCare CoordinationTotal Knee Replacement: SharedDecision-Making: Trial ofConservative (Non-surgical)Therapy:Percentage of patientsundergoing a total knee replacementwith documented shared decisionmaking with discussion of conservative(non-surgical) therapy prior to theprocedureThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.AAHKS XN/A/N/A‡Patient SafetyTotal Knee Replacement: VenousThromboembolic and CardiovascularRisk Evaluation:Percentage ofpatients regardless of age or genderundergoing a total knee replacementwho are evaluated for the presence orabsence of venous thromboembolic andcardiovascular risk factors within 30days prior to the procedure includingAAHKS XCMS-1600-FC 1012

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programshistory of Deep Vein Thrombosis,Pulmonary Embolism, MyocardialInfarction, Arrhythmia and StrokeOne commenter expressed generalsupport for the inclusion of thismeasure. We appreciate thecommenter’s feedback and arefinalizing it for inclusion in 2014 PQRSN/A/N/A‡Patient SafetyTotal Knee Replacement:Preoperative Antibiotic Infusion withProximal Tourniquet:Percentage ofpatients regardless of age undergoing atotal knee replacement who had theprophylactic antibiotic completelyinfused prior to the inflation of theproximal tourniquetThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.AAHKS XN/A/N/A‡Patient SafetyTotal Knee Replacement:Identification of ImplantedProsthesis in Operative Report:Percentage of patients regardless of ageor gender undergoing total kneeAAHKS XCMS-1600-FC 1013

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsreplacement whose operative reportidentifies the prosthetic implantspecifications including the prostheticimplant manufacturer, the brand nameof prosthetic implant and the size ofprosthetic implantThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.N/A/N/A‡Effective Clinical CareAnastomotic Leak Intervention:Percentage of patients aged 18 yearsand older who required an anastomoticleak intervention following gastricbypass or colectomy surgeryThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.ACS XN/A/N/A‡Effective Clinical CareUnplanned Reoperation within the 30Day Postoperative Period:Percentageof patients aged 18 years and older whohad any unplanned reoperation withinthe 30 day postoperative periodThis measure was finalized forACS XCMS-1600-FC 1014

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsinclusion in 2014 PQRS in the CY 2013PFS Final Rule.N/A/N/A‡Effective Clinical CareUnplanned Hospital Readmissionwithin 30 Days of PrincipalProcedure:Percentage of patients aged18 years and older who had anunplanned hospital readmission within30 days of principal procedureThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.ACS XN/A/N/A‡Effective Clinical CareSurgical Site Infection (SSI):Percentage of patients aged 18 yearsand older who had a surgical siteinfection (SSI)This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.ACS XN/A/N/A‡Person and CaregiverCentered Experienceand OutcomesPatient-Centered Surgical RiskAssessment and Communication:Percentage of patients who underwent anon-emergency surgery who had theirpersonalized risks of postoperativecomplications assessed by their surgicalACS X XCMS-1600-FC 1015

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsteam prior to surgery using a clinicaldata-based, patient-specific riskcalculator and who received personaldiscussion of those risks with thesurgeonOne commenter requested clarificationregarding the target patient populationand the patient-specific risk calculator.The commenter encouraged CMS toprovide clarification to providersregarding measure applicability andguidance on which measures CMSbelieves are best suited for an eligibleprofessional or group practice to report.Please note that these questions are nottypically addressed in rulemaking. Weurge the commenters to review the 2014PQRS program documentation andcontact the QualityNet Help Desk forassistance with reporting applicablemeasures.N/A/N/A‡Communication andCare CoordinationOptimizing Patient Exposure toIonizing Radiation: Utilization of aStandardized Nomenclature forComputed Tomography (CT)AMA-PCPI XCMS-1600-FC 1016

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsImaging Description:Percentage ofcomputed tomography (CT) imagingreports for all patients, regardless ofage, with the imaging study namedaccording to a standardizednomenclature and the standardizednomenclature is used in institution’scomputer systemsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.N/A/N/A‡Patient SafetyOptimizing Patient Exposure toIonizing Radiation: Count ofPotential High Dose RadiationImaging Studies: ComputedTomography (CT) and CardiacNuclear Medicine Studies:Percentageof computed tomography (CT) andcardiac nuclear medicine(myocardialperfusion studies)imaging reports forallpatients, regardless of age,thatdocument a count ofknown previousCT (any type of CT) and cardiacnuclear medicine (myocardialperfusion) studies that the patient hasAMA-PCPI XCMS-1600-FC 1017

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsreceived in the 12-month period prior tothe current studyThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.N/A/N/A‡Patient SafetyOptimizing Patient Exposure toIonizing Radiation: Reporting to aRadiation Dose Index Registry:Percentage of total computedtomography (CT) studies performed forall patients, regardless of age, that arereported to a radiation dose indexregistry AND that include at aminimum selected data elementsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.AMA-PCPI XN/A/N/A‡Communication andCare CoordinationOptimizing Patient Exposure toIonizing Radiation: ComputedTomography (CT) Images Availablefor Patient Follow-up andComparison Purposes:Percentage offinal reports for computed tomography(CT) studies performed for all patients,AMA-PCPI XCMS-1600-FC 1018

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsregardless of age, which document thatDigital Imaging and Communicationsin Medicine (DICOM) format imagedata are available to non-affiliatedexternal entities on a secure, media free,reciprocally searchable basis withpatient authorization for at least a 12-month period after the studyThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.N/A/N/A‡Communication andCare CoordinationOptimizing Patient Exposure toIonizing Radiation: Search for PriorComputed Tomography (CT)Imaging Studies Through a Secure,Authorized, Media-Free, SharedArchive:Percentage of final reports ofcomputed tomography (CT) studiesperformed for all patients, regardless ofage, which document that a search forDigital Imaging and Communicationsin Medicine (DICOM) format imageswas conducted for prior patient CTimaging studies completed at nonaffiliated external entities within theAMA-PCPI XCMS-1600-FC 1019

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programspast 12-months and are availablethrough a secure, authorized, mediafree, shared archive prior to an imagingstudy being performedThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.N/A/N/A‡Communication andCare CoordinationOptimizing Patient Exposure toIonizing Radiation: Appropriateness:Follow-up CT Imaging forIncidentally Detected PulmonaryNodules According to RecommendedGuidelines:Percentage of final reportsfor CT imaging studies of the thorax forpatients aged 18 years and older withdocumented follow-uprecommendations for incidentallydetected pulmonary nodules (eg,follow-up CT imaging studies neededor that no follow-up is needed) based ata minimum on nodule size AND patientrisk factorsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013AMA-PCPI XCMS-1600-FC 1020

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsPFS Final Rule.0060/N/A‡148v2 Effective Clinical CareHemoglobin A1c Test for PediatricPatients:Percentage of patients 5-17years of age with diabetes with aHbA1c test during the measurementperiodThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.NCQA X MU20108/N/A‡136v3 Effective Clinical CareADHD: Follow-Up Care for ChildrenPrescribed AttentionDeficit/Hyperactivity Disorder (ADHD)Medication:Percentage of children 6-12years of age and newly dispensed amedication for attentiondeficit/hyperactivity disorder (ADHD) whohad appropriate follow-up care. Two ratesare reported.a. Percentage of children who had onefollow-up visit with a practitioner withprescribing authority during the 30-DayInitiation Phase.b. Percentage of children who remainedon ADHD medication for at least 210days and who, in addition to the visit inthe Initiation Phase, had at least twoadditional follow-up visits with aNCQA X MU2CMS-1600-FC 1021

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programspractitioner within 270 days (9 months)after the Initiation Phase ended.This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.0110/N/A‡169v2 Effective Clinical CareBipolar Disorder and MajorDepression: Appraisal for alcohol orchemical substance use:Percentage ofpatients with depression or bipolardisorder with evidence of an initialassessment that includes an appraisalfor alcohol or chemical substance use.This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.CQAIMH X MU20403/N/A‡62v2 Effective Clinical CareHIV/AIDS: Medical Visit:Percentageof patients, regardless of age, with adiagnosis of HIV/AIDS with at leasttwo medical visits during themeasurement year with a minimum of90 days between each visitThis measure was finalized forinclusion in 2014 PQRS in the CY 2013NCQA XMU2CMS-1600-FC 1022

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsPFS Final Rule.0608/N/A‡158v2 Effective Clinical CarePregnant women that had HBsAgtesting:This measure identifiespregnant women who had a HBsAg(hepatitis B) test during theirpregnancy.This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.OptumInsight X MU20710/N/A‡159v2 Effective Clinical CareDepression Remission at TwelveMonths:Adult patients age 18 andolder with major depression ordysthymia and an initial PHQ-9 score >9 who demonstrate remission at twelvemonths defined as PHQ-9 score lessthan 5. This measure applies to bothpatients with newly diagnosed andexisting depression whose currentPHQ-9 score indicates a need fortreatmentOne commenter was concerned that thismeasure was only proposed forinclusion using the EHR-basedreporting option. In an effort toMNCM X MU2CMS-1600-FC 1023

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programscompletely align programs, allmeasures in the EHR IncentiveProgram have been adopted for 2014PQRS EHR-based reporting option. ForCY 2014, CMS was unable todetermine the feasibility ofincorporation of this measure for otherreporting options; however, CMSintends to continue working towardcomplete alignment of measurespecifications across programswhenever possible and incorporation ofthis measure in other PQRS reportingoptions may considered in the future.This measure identifies specific gaps incare and encourages more providerreporting to assess quality care whileallowing specialty professionals toparticipate in the program. For thesereasons, we are finalizing this measureas proposed for PQRS beginning in2014.0712/N/A‡160v2 Effective Clinical CareDepression Utilization of the PHQ-9Tool:Adult patients age 18 and olderwith the diagnosis of major depressionMNCM X MU2CMS-1600-FC 1024

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsor dysthymia who have a PHQ-9 tooladministered at least once during a 4month period in which there was aqualifying visit.One commenter was concerned that thismeasure was only proposed forinclusion using the EHR-basedreporting option. In an effort tocompletely align programs, allmeasures in the EHR IncentiveProgram have been adopted for 2014PQRS EHR-based reporting option. ForCY 2014, CMS was unable todetermine the feasibility ofincorporation of this measure for otherreporting options; however, CMSintends to continue working towardcomplete alignment of measurespecifications across programswhenever possible and incorporation ofthis measure in other PQRS reportingoptions may considered in the future.This measure identifies specific gaps incare and encourages more providerCMS-1600-FC 1025

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsreporting to assess quality care whileallowing specialty professionals toparticipate in the program. For thesereasons, we are finalizing this measureas proposed for PQRS beginning in2014.1401/N/A‡82v1 Community/Population HealthMaternal Depression Screening:Thepercentage of children who turned 6months of age during the measurementyear, who had a face-to-face visitbetween the clinician and the childduring child’s first 6 months, and whohad a maternal depression screening forthe mother at least once between 0 and6 months of life.One commenter was concerned that thismeasure was only proposed forinclusion using the EHR-basedreporting option. In an effort tocompletely align programs, allmeasures in the EHR IncentiveProgram have been adopted for 2014PQRS EHR-based reporting option. ForCY 2014, CMS was unable todetermine the feasibility ofNCQA X MU2CMS-1600-FC 1026

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsincorporation of this measure for otherreporting options; however, CMSintends to continue working towardcomplete alignment of measurespecifications across programswhenever possible and incorporation ofthis measure in other PQRS reportingoptions may considered in the future.This measure identifies specific gaps incare and encourages more providerreporting to assess quality care whileallowing specialty professionals toparticipate in the program. For thesereasons, we are finalizing this measureas proposed for PQRS beginning in2014.N/A/N/A‡65v3 Effective Clinical CareHypertension: Improvement in BloodPressure:Percentage of patients aged18-85 years of age with a diagnosis ofhypertension whose blood pressureimproved during the measurementperiod.One commenter expressed concern withattaching numerical targets to bloodCMS X MU2CMS-1600-FC 1027

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programspressure measures, stating this measurestill encourages a focus on managementof numbers over management ofpatients. CMS appreciates thecommenters’ feedbackandacknowledges that the focus ofmedicine should be with themanagement of the patients.Analytically, this measure excludespatients that may have clinicalconditions such as end-stage renaldisease, pregnancy and/or renaltransplant, hemodialysis or peritonealdialysis. Exclusion of these populationsis an attempt to allow the bloodpressure measurement as guide lined byJNC-7 to apply to a more generalizedpopulation of patient diagnosed withhypertension. In an effort to completelyalign programs, all measures in theEHR Incentive Program have beenadopted for the PQRS EHR-basedreporting option beginning in 2014.Alignment of measures containedwithin multiple CMS reportingprograms eases the burden of reportingCMS-1600-FC 1028

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsand encourages eligible professionals tosubmit quality clinical data on careprovided for Medicare beneficiaries.For these reasons, we are finalizing thismeasure as proposed.N/A/N/A‡50v2 Communication andCare CoordinationClosing the referral loop: receipt ofspecialist report:Percentage ofpatients with referrals, regardless ofage, for which the referring providerreceives a report from the provider towhom the patient was referred.This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.CMS X MU2N/A/N/A‡66v2 Person and CaregiverCentered Experienceand OutcomesFunctional Status Assessment forKnee Replacement:Percentage ofpatients aged 18 years and older withprimary total knee arthroplasty (TKA)who completed baseline and follow-up(patient-reported) functional statusassessments.This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.CMS X MU2CMS-1600-FC 1029

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting ProgramsN/A/N/A‡56v2 Person and CaregiverCentered Experienceand OutcomesFunctional Status Assessment for HipReplacement:Percentage of patientsaged 18 years and older with primarytotal hip arthroplasty (THA) whocompleted baseline and follow-up(patient-reported) functional statusassessmentsThis measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.CMS X MU2N/A/N/A‡90v3 Person and CaregiverCentered Experienceand OutcomesFunctional Status Assessment forComplex Chronic Conditions:Percentage of patients aged 65 yearsand older with heart failure whocompleted initial and follow-up patientreported functional status assessmentsOne commenter appreciates the valueof assessing functional status in heartfailure patients, however, is concernedthe measure requires a questionnaireand the potential of associated cost.CMS would like to note that many ofthe assessment tools are readilyavailable to the public and generally doCMS X MU2CMS-1600-FC 1030

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsnot have an associated cost. We arefinalizing this measure as for inclusionin the EHR-based reporting option forPQRS beginning in 2014.N/A/N/A‡75v2 Effective Clinical CareChildren Who Have Dental Decay orCavities:Percentage of children, age 0-20 years, who have had tooth decay orcavities during the measurement period.This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.CMS X MU2N/A/N/A‡74v3 Effective Clinical CarePrimary Caries PreventionIntervention as Offered by PrimaryCare Providers, including Dentists:Percentage of children, age 0-20 years,who received a fluoride varnishapplication during the measurementperiod.This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.CMS X MU2N/A/N/A‡179v2Patient SafetyADE Prevention and Monitoring:Warfarin Time in TherapeuticRange:Average percentage of time inCMS X MU2CMS-1600-FC 1031

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programswhich patients aged 18 and older withatrial fibrillation who are on chronicwarfarin therapy have InternationalNormalized Ratio (INR) test resultswithin the therapeutic range (i.e., TTR)during the measurement period.One commenter supported the inclusionof this measure but cautioned againstthe use of a single measure andmethodology for tracking theappropriateness of anticoagulanttherapy. CMS appreciates thecommenters support and feedback.This measure is analytically challengingfor reporting in a claims-based orregistry-based mechanisms, therefore iscurrently implemented as an EHRmeasure. Patients with atrial fibrillationare at an increased risk for stroke,therefore CMS agrees that this measureis a valuable measurement withinPQRS and the EHR Incentive Program.In an effort to completely alignprograms, all measures in the EHRIncentive Program have been adoptedCMS-1600-FC 1032

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsfor 2014 PQRS EHR-based reportingoption. CMS appreciates the suggestionand encourages societies and measuredevelopers to develop measures theybelieve address possible gaps in qualityreporting. We are finalizing thismeasure for inclusion, as proposed,beginning in 2014.N/A/N/A‡77v2 Effective Clinical CareHIV/AIDS: RNA Control for Patientswith HIV:Percentage of patients aged13 years and older with a diagnosis ofHIV/AIDS, with at least two visitsduring the measurement year, with atleast 90 days between each visit, whosemost recent HIV RNA level is <200copies/mL.This measure was finalized forinclusion in 2014 PQRS in the CY 2013PFS Final Rule.CMS X MU21365/N/A‡177v2 Patient SafetyChild and Adolescent MajorDepressive Disorder (MDD): SuicideRisk Assessment:Percentage of patientvisits for those patients aged 6 through17 years with a diagnosis of majordepressive disorder with an assessmentAMA-PCPI X MU2CMS-1600-FC 1033

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsfor suicide riskOne commenter supported the additionof this measure and it’s alignment withthe EHR Incentive Program. Weappreciate the support of this measureand our actions to align qualityreporting programs. Anothercommenter was concerned that thismeasure was only proposed forinclusion using the EHR-basedreporting option. For CY 2014, CMSwas unable to determine the feasibilityof incorporation of this measure forother reporting options; however, CMSintends to continue working towardcomplete alignment of measurespecifications across programswhenever possible and incorporation ofthis measure in other PQRS reportingoptions may considered in the future.This measure identifies specific gaps incare and encourages more providerreporting to assess quality care whileallowing specialty professionals toCMS-1600-FC 1034

NQF/ PQRS CMS E-Measure IDNational QualityStrategy DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Other Quality Reporting Programsparticipate in the program. For thesereasons, we are finalizing this measureas proposed for PQRS beginning in2014.‡This measure is new to the Physician Quality Reporting System and has been adopted for reporting beginning in CY 2014.¥ Titles and descriptions in this table are aligned with the 2014Physician Quality Reporting System Claims and Qualified Registry measure titles anddescriptions, and may differ based on reporting mechanism withinPQRS. Additionally, there may be tittle and description variations for the same measure acrossother quality reporting programs. Please reference the NationalQuality Forum (NQF) and Physician Quality Reporting System numbers for clarification. Thiscolumn also contains summary of public comments and CMS’s responses, if applicable.Table 53 includes the measures we proposed toinclude in the PQRS measure set for 2014and beyond but, for the reasons specified inTable 53, we are not finalizing for 2014 and beyond.TABLE 53: Measures Proposed for Inclusion in the Physician Quality Reporting System Measure Beginning in 2014 that are NotFinalized to be Included in the Physician Quality Reporting System Measure Beginning in 2014

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Quality Reporting ProgramsCMS-1600-FC 1035N/A/N/APatient SafetyAtopic Dermatitis: Overuse: Role of Antihistamine:Percentage of patients aged 25 years or younger seen at oneor more visits within a 12-month period with a diagnosis ofatopic dermatitis, who did not have a diagnosis of allergicrhinitis or urticaria, who were prescribed oral nonsedatingantihistaminesOne commenter supported the inclusion of this measure as itwould gather data on the “percentage of patients aged 25years or younger seen at one or more visits within a 12-month period with a diagnosis of atopic dermatitis, who didnot have a diagnosis of allergic rhinitis or urticaria, whowere prescribed oral nonsedating antihistamines.” Anothercommenter did not support inclusion of this measure in thePQRS program.We agree with the latter commenter that this measure shouldnot be included and therefore, we are not finalizing it forinclusion in 2014 PQRS.AMA-PCPI XN/A/N/AEffectiveClinical CareNeurosurgery: Initial Visit:The percentage of patientsaged 18 through 80 years with a diagnosis of a neurosurgicalprocedure or pathology whohad function assessed during theinitial visit to the clinician for the episode of the conditionThe measure owner withdrewsupport of this measure andtherefore, we are not finalizing it for inclusion in 2014PQRS.AANS/CNS XCMS-1600-FC 10360372/N/APatient SafetyVTE-2: Intensive Care UnitVenous ThromboembolismProphylaxis:This measure assesses the number of patients whoreceived VTE prophylaxis or have documentation why no VTEprophylaxis was given the day of or the day after the initialadmission (or transfer) to the Intensive Care Unit (ICU) or surgeryend date for surgeries that start the day of or the day after ICUadmission (or transfer)Several commenters appreciate CMS’ efforts to align thePQRS measures with other quality reporting program butwere concerned about the ability to implement this measurein PQRS. CMS appreciates the support of its actions to alignquality reporting programs with the inclusion of the IQRmeasures. However, CMS is deferring the incorporation ofthe IQR measures until 2015 due to operational issues withimplementation. As such, we are not finalizing this measurefor inclusion in 2014 PQRS.The JointCommissionX IQRN/A/N/A Patient SafetyVTE-4: Venous Thromboembolism Patients ReceivingUnfractionated Heparin with Dosages/Platelet CountMonitoring by Protocol:This measure assesses the number ofpatients diagnosed with confirmed VTE who received intravenous(IV) UFH therapy dosages AND had their platelet countsmonitored using defined parameters such as a nomogram orprotocol.Several commenters appreciate CMS’efforts to align the PQRSmeasures with other quality reporting program but were concernedabout the ability to implement this measure in PQRS. CMSappreciates the support of its actions to align quality reportingprograms with the inclusion of the IQR measures. However, CMSis deferring the incorporation of the IQR measures until 2015 dueto operational issues with implementation. As such, we are notfinalizing this measure for inclusion in 2014 PQRS.The JointCommissionX IQRCMS-1600-FC 10370495/N/A Communicationand CareCoordinationED-1a: Median Time from EDArrival to ED Departure forAdmitted ED Patients - Overall Rate:Median time fromemergency department arrival to time of departure from theemergency room for patients admitted to the facility from theemergency departmentSeveral commenters appreciate CMS’efforts to align the PQRSmeasures with other quality reporting program but were concernedabout the ability to implement this measure in PQRS. CMSappreciates commenter’s support ofthis measure but is deferringthe incorporation of the IQR measures until 2015 due tooperational issues with implementation. As such, we are notfinalizing this measure for inclusion in 2014 PQRS.CMS X IQRCMS-1600-FC 10381659/N/A Community/PopulationHealthIMM-1c: Pneumococcal Immunization (PPV23) – HighRisk Populations (Age 5 through 64 years):Thisprevention measure addresses acute care hospitalizedinpatients 65 years of age and older (IMM-1b) ANDinpatients aged between 5 and 64 years (IMM-1c) who areconsidered high risk and were screened for receipt ofpneumococcal vaccine and were vaccinated prior todischarge if indicated. The numerator captures two activities;screening and the intervention of vaccine administrationwhen indicated. As a result, patients who had documentedcontraindications to pneumococcal vaccine, patients whowere offered and declined pneumococcal vaccine andpatients who received pneumococcal vaccine anytime in thepast are captured as numerator eventsSeveral commenters appreciate CMS’ efforts to align thePQRS measures with other quality reporting programs. CMSappreciates the support of its actions to align qualityreporting programs with the inclusion of the IQR measures.Other commenters did not support inclusion of this measurein the PQRS program due to its suspension from the IQRprogram and difficulties implementing this measure inPQRS. We agree with the latter commenters that thismeasure should not be included and therefore, we are notfinalizing it for inclusion in 2014 PQRS. Implementation ofall IQR measures in PQRS has been deferred until 2015.CMS X IQRCMS-1600-FC 10390147/N/A Patient SafetyPN-6: Initial Antibiotic Selection for CAP inImmunocompetentPatient:Immunocompetent patients with Community-AcquiredPneumonia who receive an initialantibiotic regimen during thefirst 24 hours that is consistent with current guidelinesSeveral commenters appreciate CMS’efforts to align the PQRSmeasures with other quality reporting programs. CMS appreciatesthe support of its actions to align quality reporting programs withthe inclusion of the IQR measures. Other commenters did notsupport inclusion of this measure due to difficulties implementingthis measure in PQRS. We agree with the latter commenters thatthis measure should not be included and therefore, we are notfinalizing it for inclusion in 2014 PQRS. Implementation of allIQR measures in PQRS has been deferred until 2015.CMS X IQR0495/N/A Communicationand CareCoordinationED-1d: Median Time from EDArrival to ED Departure forAdmitted Patients - Psychiatric/Mental Health Patients:Median time from emergency department arrival to time ofdeparture from the emergency room for patients admitted to thefacility from the emergency departmentOne commenter appreciates CMS’efforts to align the PQRSmeasures with other quality reporting programs. CMS appreciatesthe support of its actions to align quality reporting programs withthe inclusion of the IQR measures. Several commenters did notsupport inclusion of this measure due to difficulties implementingthis measure in PQRS. We agree with the latter commenters thatthis measure should not be included and therefore, we are notfinalizing it for inclusion in 2014 PQRS. Implementation of allIQR measures in PQRS has been deferred until 2015.CMS X IQRCMS-1600-FC 10400166/N/A Communicationand CareCoordinationHCAHPS: Hospital Consumer Assessment of HealthcareProviders and Systems Survey:27-items survey instrument with7 domain-level composites including: communication withdoctors, communication with nurses, responsiveness of hospitalstaff, pain control, communication about medicines, cleanlinessand quiet of the hospital environment, and discharge informationOne commenter appreciates CMS’efforts to align the PQRSmeasures with other quality reporting programs. CMS appreciatesthe support of its actions to align quality reporting programs withthe inclusion of the IQR measures. Several commenters did notsupport inclusion of this measure due to difficulties implementingthis measure in PQRS. We agree with the latter commenters thatthis measure should not be included and therefore, we are notfinalizing it for inclusion in 2014 PQRS. Implementation of allIQR measures in PQRS has been deferred until 2015.CMS X IQRN/A/N/A EffectiveClinical CareVentral Hernia, Appendectomy, AV Fistula,Cholecystectomy, Thyroidectomy, Mastectomy +/-Lymphadenectomy or SLNB, Partial Mastectomy orBreast Biopsy/Lumpectomy +/- Lymphadenectomy orSLNB: Iatrogenic Injury to Adjacent Organ/Structure:Percentage of patients age 65 and older who had aniatrogenic injury documented in the operative note,postoperative note, or progress note. Iatrogenic injury is anunplanned laceration, puncture, transection or cautery injuryto an adjacent structure (e.g.,sphincters, vasculature, nerve,other) that occurs during the index procedure, whetherrecognized at the time of surgery or post-operatively.Synonyms for the injury could include: hole, wound,perforation, tear, injury, laceration, cautery injury, damage,disruption, or defectThe measure owner withdrewsupport of this measure andtherefore, we are not finalizing it for inclusion in 2014PQRS.ACS XCMS-1600-FC 1041N/A/N/A EffectiveClinical CareBariatric Laparoscopic orOpen Roux-en Y GastricBypass, Bariatric Sleeve Gastrectomy, and Colectomy:Iatrogenic Injury to Adjacent Organ/Structure:Percentage of patients age 65 and older who had aniatrogenic injury documented in the operative note,postoperative note, or progress note. Iatrogenic injury is anunplanned laceration, puncture, transection or cautery injuryto an adjacent structure (e.g.,sphincters, vasculature, nerve,other) that occurs during the index procedure, whetherrecognized at the time of surgery or post-operatively.Synonyms for the injury could include: hole, wound,perforation, tear, injury, laceration, cautery injury, damage,disruption, or defectThe measure owner withdrewsupport of this measure andtherefore, we are not finalizing it for inclusion in 2014PQRS.ACS X¥ Titles and descriptions in this table are aligned with the 2014Physician Quality Reporting System Claims and Qualified Registry measure titles anddescriptions, and may differ based on reporting mechanism withinPQRS. Additionally, there may be tittle and description variations for the same measure acrossother quality reporting programs. Please reference the NationalQuality Forum (NQF) and Physician Quality Reporting System numbers for clarification.In Table 54, we specify the measures we proposed to removefrom reporting under the PQRS and whether, based on the commentsreceived, we are finalizing our proposal to remove these measures from reporting under the PQRS in 2014. Please note that therationale we havefor finalizing removal of each measure is specified after the measure title and description.TABLE 54: Measures To Be Removed from Reporting inthe Physician Quality Reporting System in 2014CMS-1600-FC 1042

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g rams0061/3Effective Clinical CareDiabetes Mellitus: High Blood PressureControl:Percentage of patients aged 18through 75 years with diabetes mellitus whohad most recent blood pressure in control(less than 140/90 mmHg)Rationale:Measure deletion due to directionof eliminating duplicative measures withinPQRS.One commenter supported the removal ofthis measure, while another commentercautioned against removal of this measureuntil new guidelines are established fordevelopment of a comprehensive bloodpressure control measure that is clinicallyrelevant for Ischemic Vascular Disease andDiabetes. A third commenter cautionedagainst the removal due to the importance ofblood pressure control for patients withdiabetes. Additionally, commenters wereconcerned with the removal of this measureas it impacts the number of measuresavailable to eligible professionals.NCQA X X X X MU1CMS-1600-FC 1043

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsWe appreciate the comments and understandthe concerns. Due to our desire to moveaway from claims-based reporting, we arenot finalizing this measure for inclusion in2014 PQRS.N/A/86Effective Clinical CareHepatitis C: Antiviral TreatmentPrescribed:Percentage of patients aged 18years and older with a diagnosis of chronichepatitis C who were prescribed at aminimum peginterferon and ribavirin therapywithin the 12-month reporting periodRationale:Measure lost NQFEndorsement/Measure Owner Support.One commenter supported the removal ofthis measure as it has been retired from themedical professional society’s measure set.We appreciate the commenters feedback andare not finalizing this measure for reportingunder PQRS.AMA-PCPI X X XN/A/89Effective Clinical CareHepatitis C: Counseling Regarding Risk ofAlcohol Consumption:Percentage ofpatients aged 18 years and older with adiagnosis of hepatitisC who were counseledAMA-PCPI X X XCMS-1600-FC 1044

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsabout the risks of alcohol use at least oncewithin 12-monthsRationale:Measure lost NQFEndorsement/Measure Owner Support.One commenter supported the removal ofthis measure as it has been retired from themedical professional society’s measure set.We appreciate the commenters feedback andare not finalizing this measure for reportingunder PQRS.N/A/90Effective Clinical CareHepatitis C: Counseling Regarding Use ofContraception Prior to Antiviral Therapy:Percentage of female patients aged 18through 44 years and all men aged 18 yearsand older with a diagnosis of chronichepatitis C who are receiving antiviraltreatment who were counseled regardingcontraception prior to the initiation oftreatmentRationale:Measure lost NQFEndorsement/Measure Owner Support.AMA-PCPI X X XCMS-1600-FC 1045

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsOne commenter supported the removal ofthis measure as it has been retired from themedical professional society’s measure set.We appreciate the commenters feedback andare not finalizing this measure for reportingunder PQRS.N/A/161Effective Clinical CareHIV/AIDS: Adolescent and Adult Patientswith HIV/AIDS Who Are PrescribedPotent Antiretroviral Therapy:Percentageof patients with a diagnosis of HIV/AIDSaged 13 years and older: who have a historyof a nadir CD4+ cell count below 350/mm3or who have a history of an AIDS-definingcondition, regardless of CD4+ cell count; orwho are pregnant, regardless of CD4+ cellcount or age, who were prescribed potentantiretroviral therapyRationale:Measure lost NQFEndorsement/Measure Owner Support.CMS solicited but received no comments onthis measure. Therefore, for the reasons westated in the proposed rule, we are finalizingour proposal to retire this measure fromAMAPCPI/NCQAX XCMS-1600-FC 1046

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsPQRS beginning in 2014.N/A/162Effective Clinical CareHIV/AIDS: HIV RNA Control After SixMonths of Potent Antiretroviral Therapy:Percentage of patients aged 13 years andolder with a diagnosis of HIV/AIDS who arereceiving potent antiretroviral therapy, whohave a viral load below limits ofquantification after at least 6 months ofpotent antiretroviral therapy or patientswhose viral load is not below limits ofquantification after at least 6 months ofpotent antiretroviral therapy and havedocumentation of a plan of careRationale:Measure lost NQFEndorsement/Measure Owner Support.CMS solicited but received no comments onthis measure. We are finalizing our proposalto retire this measure from PQRS beginningin 2014.AMAPCPI/NCQAX XN/A/184Community/PopulationHealthHepatitis C: Hepatitis B Vaccination inPatients with HCV:Percentage of patientsaged 18 years and older with a diagnosis ofhepatitis C who received at least oneAMA- PCPI X XCMS-1600-FC 1047

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsinjection of hepatitis B vaccine, or who havedocumented immunity to hepatitis BRationale:Measure lost NQFEndorsement/Measure Owner Support.Two commenters did not agree with theremoval of this measure and requested thatCMS reconsider, stating this measureaddresses an important aspect of care.Additionally, this measure is paired withPQRS 183 which was proposed for continuedinclusion for the 2014 program year. Weappreciate the commenter’s feedback, but,based on the rationale provided above, weare not retaining this measure for reportingunder PQRS.N/A/188Communication andCare CoordinationReferral for Otologic Evaluation forPatients with Congenital or TraumaticDeformity of the Ear:Percentage ofpatients aged birth and older referred to aphysician (preferably a physician withtraining in disorders of the ear) for anotologic evaluation subsequent to anaudiologic evaluation after presenting with aAQC X XCMS-1600-FC 1048

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramscongenital or traumatic deformity of the ear(internal or external)Rationale:Measure deletion due to lowutilization and lack of clinical relevance forthe Medicare population.CMS solicited but received no comments onthis measure. Therefore, for the reasonsprovided above, we are finalizing ourproposal to retire this measure from PQRSbeginning in 2014.N/A/200Effective Clinical CareHeart Failure: Warfarin Therapy forPatients with Atrial Fibrillation:Percentage of all patients aged 18 and olderwith a diagnosis of heart failure andparoxysmal or chronic atrial fibrillation whowere prescribed warfarin therapyRationale:Measure lost NQFEndorsement/Measure Owner Support.One commenter did not support theretirement of this measure. Severalcommenters supported the removal of thisAMAPCPI/ACCF/AHAX MU1CMS-1600-FC 1049

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsmeasure as it has been retired from themedical professional society’s measure set,while one commenter did not support theretirement, stating it is pertinent to the fieldof electrophysiology. We appreciate thecommenters feedback and for the reasonsidentified, are not finalizing this measure forreporting under PQRS0073/201Effective Clinical CareIschemic Vascular Disease (IVD): BloodPressure Management:Percentage ofpatients aged 18 to 75 years with IschemicVascular Disease (IVD) who had most recentblood pressure in control (less than 140/90mmHg)Rationale:Measure deletion due to directionof eliminating duplicative measures withinPQRS.One commenter supported the removal ofthis measure. Another commenter cautionedagainst removal of this measure until newguidelines are established for development ofa comprehensive blood pressure controlmeasure that is clinically relevant forNCQA X X X X MU1CMS-1600-FC 1050

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsIschemic Vascular Disease and Diabetes.Additionally, commenters were concernedwith the removal of this measure as itimpacts the number of measures available toeligible professionals. We appreciate thecomments and understand the concerns. Dueto our desire to move away from claimsbased reporting, we are not finalizing thismeasure for inclusion in 2014 PQRS.0410/208 Effective Clinical CareHIV/AIDS: Sexually Transmitted DiseaseScreening for Syphilis:Percentage of patientsaged 13 years and older with a diagnosis ofHIV/AIDS who were screened for syphilis atleast once within 12 monthsRationale:Measure owner combined NQF 0410with NQF 0409.CMS solicited but received no comments on thismeasure. Therefore, we are finalizing ourproposal to retire this measure from PQRSbeginning in 2014.AMA-PCPI/NCQA X X0445/209Effective Clinical CareFunctional Communication Measure -Spoken Language Comprehension:Percentage of patients aged 16 years andolder with a diagnosis of late effects ofcerebrovascular disease (CVD) that makeprogress on the Spoken LanguageASHA XCMS-1600-FC 1051

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsComprehension Functional CommunicationMeasureRationale:Measure lost Measure Ownersupport.One commenter disagreed with CMS’decision to retire this measure due to theneed for clinically relevant measures ofoutcome and quality for speech-languagepathologists to report. We appreciate thecommenters’ feedback but for the reasonabove we are not retaining this measure forreporting under PQRS.0449/210Effective Clinical CareFunctional Communication Measure –Attention:Percentage of patients aged 16years and older with a diagnosis of lateeffects of cerebrovascular disease (CVD) thatmake progress on the Attention FunctionalCommunication MeasureRationale:Measure lost Measure Ownersupport.One commenter disagreed with CMS’ASHA XCMS-1600-FC 1052

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsdecision to retire this measure due to theneed for clinically relevant measures ofoutcome and quality for speech-languagepathologists to report. We appreciate thecommenters’ feedback but we are notretaining this measure for reporting underPQRS for the reason above.0448/211Effective Clinical CareFunctional Communication Measure –Memory:Percentage of patients aged 16years and older with a diagnosis of lateeffects of cerebrovascular disease (CVD) thatmake progress on the Memory FunctionalCommunication MeasureRationale:Measure lost Measure Ownersupport.One commenter disagreed with CMS’decision to retire this measure due to theneed for clinically relevant measures ofoutcome and quality for speech-languagepathologists to report. We appreciate thecommenters’ feedback but, for the reasonsstated above, we are not retaining thismeasure for reporting under PQRS.ASHA XCMS-1600-FC 1053

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g rams0447/212Effective Clinical CareFunctional Communication Measure -Motor Speech:Percentage of patients aged16 years and older with a diagnosis of lateeffects of cerebrovascular disease (CVD) thatmake progress on the Motor SpeechFunctional Communication MeasureRationale:Measure lost Measure Ownersupport.One commenter disagreed with CMS’decision to retire this measure due to theneed for clinically relevant measures ofoutcome and quality for speech-languagepathologists to report. We appreciate thecommenters’ feedback but, for the reasonsstated above, we are not retaining thismeasure for reporting under PQRS.ASHA X0446/213Effective Clinical CareFunctional Communication Measure –Reading:Percentage of patients aged 16years and older with a diagnosis of lateeffects of cerebrovascular disease (CVD) thatmake progress on the Reading FunctionalCommunication MeasureASHA XCMS-1600-FC 1054

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsRationale:Measure lost Measure Ownersupport.One commenter disagreed with CMS’decision to retire this measure due to theneed for clinically relevant measures ofoutcome and quality for speech-languagepathologists to report. We appreciate thecommenters’ feedback but, for the reasonsstated above, we are not retaining thismeasure for reporting under PQRS.0444/214Effective Clinical CareFunctional Communication Measure -Spoken Language Expression:Percentageof patients aged 16 years and older with adiagnosis of late effects of cerebrovasculardisease (CVD) that make progress on theSpoken Language Expression FunctionalCommunication MeasureRationale:Measure lost Measure Ownersupport.One commenter disagreed with CMS’decision to retire this measure due to theneed for clinically relevant measures ofASHA XCMS-1600-FC 1055

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsoutcome and quality for speech-languagepathologists to report. We appreciate thecommenters’ feedback but, for the reasonsstated above, we are not retaining thismeasure for reporting under PQRS.0442/215Effective Clinical CareFunctional Communication Measure –Writing:Percentage of patients aged 16years and older with a diagnosis of lateeffects of cerebrovascular disease (CVD) thatmake progress on the Writing FunctionalCommunication MeasureRationale:Measure lost Measure Ownersupport.One commenter disagreed with CMS’decision to retire this measure due to theneed for clinically relevant measures ofoutcome and quality for speech-languagepathologists to report. We appreciate thecommenters’ feedback but, for the reasonsstated above, we are not retaining thismeasure for reporting under PQRS.ASHA X0443/216Effective Clinical CareFunctional Communication Measure –Swallowing:Percentage of patients aged 16ASHA XCMS-1600-FC 1056

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsyears and older with a diagnosis of lateeffects of cerebrovascular disease (CVD) thatmake progress on the Swallowing FunctionalCommunication MeasureRationale:Measure lost Measure Ownersupport.One commenter disagreed with CMS’decision to retire this measure due to theneed for clinically relevant measures ofoutcome and quality for speech-languagepathologists to report. We appreciate thecommenters’ feedback but, for the reasonsstated above, we are not retaining thismeasure for reporting under PQRS.0013/237Effective Clinical CareHypertension (HTN): Blood PressureMeasurement:Percentage of patient visitsfor patients aged 18 years and older with adiagnosis of HTN with blood pressure (BP)recordedRationale:Deletion due to MU2 alignment.Several commenters supported the removalAMA-PCPI XCMS-1600-FC 1057

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsof this measure as it has been retired from themedical professional society’s measure set.We appreciate the commenters’ feedback andare not finalizing this measure for reportingunder PQRS.N/A/244Effective Clinical CareHypertension: Blood PressureManagement:Percentage of patients aged18 years and older with a diagnosis ofhypertension seen within a 12 month periodwith a blood pressure < 140/90 mmHg ORpatients with a blood pressure≥140/90mmHg and prescribed two or more antihypertensive medications during the mostrecent office visitRationale:Measure deletion due to directionof eliminating duplicative measures withinPQRS.Two commenters believed this measureaddresses important aspects of care whileanother is concerned its impact on thenumber of measures available to eligibleprofessionals.AMAPCPI/ACCF/AHAXCMS-1600-FC 1058

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsWe appreciate the comment and understandthe concerns. Due to our desire to moveaway from claims-based reporting, we areremoving this measure from the PQRSmeasure set.0503/252 Effective Clinical CareAnticoagulation for Acute PulmonaryEmbolus Patients:Anticoagulation orderedfor patients who have been discharged fromthe emergency department (ED) with adiagnosis of acute pulmonary embolusRationale:Measure lost Measure Ownersupport.Two commenters requested that CMS retainthis measure although it has lost measureowner support and NQF endorsement. CMSappreciates the commenters’ desire to retainthis measure in the PQRS program andencourages them to re-tool the measure asneeded and submit during the annual Call forMeasures for possible future inclusion.ACEP X XN/A/256Communication andCare CoordinationSurveillance after EndovascularAbdominal Aortic Aneurysm Repair(EVAR):Percentage of patients 18 years ofSVS XCMS-1600-FC 1059

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsage or older undergoing endovascularabdominal aortic aneurysm repair (EVAR)who have at least one follow-up imagingstudy after 3 months and within 15 months ofEVAR placement that documents aneurysmsac diameter and endoleak statusRationale:Measure lost Measure Ownersupport.CMS solicited but received no comments onthis measure. Therefore, we are finalizing ourproposal to retire this measure from PQRSbeginning in 2014.0012/306Community/PopulationHealthPrenatal Care: Screening for HumanImmunodeficiency Virus (HIV):Percentage of patients, regardless of age,who gave birth during a 12-month periodwho were screened for HIV infection duringthe first or second prenatal visitRationale:Deletion due to MU2 alignment.One commenter supported the removal ofthis measure as it has been retired from theAMA-PCPI X MU1CMS-1600-FC 1060

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsmedical professional society’s measure set.We appreciate the commenter’s feedback andare not finalizing this measure for reportingunder PQRS.0014/307Patient SafetyPrenatal Care: Anti-D Immune Globulin:Percentage of D (Rh) negative, unsensitizedpatients, regardless of age, who gave birthduring a 12-month period who received antiD immune globulin at 26-30 weeks gestationRationale:Deletion due to MU2 alignment.One commenter supported the removal ofthis measure as it has been retired from themedical professional society’s measure set.We appreciate the commenter’s feedback andare not finalizing this measure for reportingunder PQRS.AMA-PCPI X MU10027/308Community/PopulationHealthSmoking and Tobacco Use Cessation,Medical Assistance: a. Advising Smokersand Tobacco Users to Quit, b. DiscussingSmoking and Tobacco Use CessationMedications, c. Discussing Smoking andTobacco Use Cessation Strategies:Percentage of patients aged 18 years andNCQA X MU1CMS-1600-FC 1061

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsolder who were current smokers or tobaccousers, who were seen by a practitioner duringthe measurement year and who receivedadvice to quit smoking or tobacco use orwhose practitioner recommended ordiscussed smoking or tobacco use cessationmedications, methods or strategiesRationale:Deletion due to MU2 alignment.One commenter did not support the removalof this measure, stating it is an importantmeasure in attempting to reduce tobaccousage. Another commenter was concernedtobacco cessation strategies would not becaptured in existing smoking measures.We respectfully disagree and are thereforenot finalizing this measure for inclusion in2014 PQRS. We believe the tobaccocessation finalized in the PQRS measure setsuffice to capture cessation consultation.0575/313Effective Clinical CareDiabetes Mellitus: Hemoglobin A1cControl (< 8%):The percentage of patients18 through 75 years of age with a diagnosisNCQA XCMS-1600-FC 1062

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsof diabetes (type 1 or type 2) who hadHbA1c < 8%Rationale:Deletion due to MU2 alignment.One commenter was concerned with theremoval of this measure as it drives betterquality compared to PQRS measure #1 and ithas the potential to contribute to betteroutcomes for patients with diabetes. Anothercommenter requested the measure not beretired as it provides different clinicalinformation than PQRS measure #1 and thatalignment with other programs is not anadequate reason for removal. We appreciatethe commenters’ feedback but respectfullydisagree. It is our intention to align themeasures available for EHR-based reportingunder PQRS with the measures available forreporting under the Medicare EHR IncentiveProgram. Since this measure is not availablefor reporting under the EHR IncentiveProgram, we do not believe it is appropriateto include in the final PQRS measure set andare therefore not finalizing for inclusion inCMS-1600-FC 1063

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g rams2014 PQRS.0493/321Communication andCare CoordinationParticipation by a Hospital, Physician orOther Clinician in a Systematic ClinicalDatabase Registry that IncludesConsensus Endorsed Quality:Participationin a systematic qualified clinical databaseregistry involves:a. Physician or other clinician submitsstandardized data elements to registry.b. Data elements are applicable to consensusendorsed quality measures.c. Registry measures shall include at leasttwo (2) representative NQF consensusendorsed measures for registry's clinicaltopic(s) and report on all patients eligible forthe selected measures.d. Registry provides calculated measuresresults, benchmarking, and qualityimprovement information to individualphysicians and clinicians.e. Registry must receive data from more than5 separate practices and may not be located(warehoused) at an individual group’spractice. Participation in a national or statewide registry is encouraged for this measure.OFMQ X XCMS-1600-FC 1064

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsf. Registry may provide feedback directly tothe provider’s local registry if one exists.Rationale:Due we believe participation in aclinical data registry is best captured underthe new qualified clinical data registryoption, CMS no longer believes this measureis necessary to report and is thereforeproposing to remove this measure.We received several comments opposing theremoval of this measure due to theimplementation of Qualified Clinical DataRegistries, stating they believe it ispremature and that the measure is animportant bridge to increased registry-basedPQRS reporting. The commenters urgedCMS to postpone the elimination of thismeasure until it has a better understanding ofhow many registries will be able to fulfill thenew Qualified Clinical Data Registry optionas proposed. We appreciate the commenters’feedback, but we are not retaining thismeasure for reporting under PQRS.N/A/N/A Communication andTotal Knee Replacement: Coordination ofAAHKS/AMA- XCMS-1600-FC 1065

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsCare CoordinationPost Discharge Care:Percentage of patientsundergoing total knee replacement whoreceived written instructions for postdischarge care including all the following:post discharge physical therapy, home healthcare, post discharge deep vein thrombosis(DVT) prophylaxis and follow-up physicianvisitsRationale:Measure Owner decision toremove this measure from Total KneeReplacement and replace with the measure:Shared Decision-Making: Trial ofConservative (Non-surgical) TherapyCMS solicited but received no comments onthis measure. Therefore, we are finalizing ourproposal to retire this measure from PQRSbeginning in 2014.PCPIN/A/N/A Person and CaregiverCentered Experience andOutcomesChronic Wound Care: Patient EducationRegarding Long-Term CompressionTherapy:Percentage of patients aged 18years and older with a diagnosis of venousulcer who received education regarding theneed for long term compression therapyAMA-PCPI X XCMS-1600-FC 1066

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsincluding interval replacement ofcompression stockings within the 12 monthreporting periodRationale:This measure concept is routinelymet in a clinical setting. CMS believes itwould not indicate a true quality outcome.Two commenters felt this measure adds animportant aspect of care related to the twochronic wound care measures currently in thePQRS program. CMS appreciates thecommenters’ feedback but as indicated in ourrationale, do not believe it would indicate atrue quality outcome. For this reason, we arenot finalizing for inclusion in PQRS.N/A/N/A Effective Clinical CareOsteoporosis: Status of Participation inWeight-Bearing Exercise and Weightbearing Exercise Advice:Percentage ofpatients aged 18 and older with a diagnosisof osteoporosis, osteopenia, or prior lowimpact fracture; women age 65 and older; ormen age 70 and older whose status regardingparticipation in weight-bearing exercise wasdocumented and for those not participatingABIM XCMS-1600-FC 1067

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsregularly who received advice within 12months to participate in weight-bearingexerciseRationale:This measures group was deleteddue to the amount of measures that hadduplicative medical concepts within thePQRS program.Several commenters opposed the deletion ofall measures originally proposed to comprisethe Osteoporosis measures group.Commenters recommended theimplementation of a revised Osteoporosismeasures group utilizing six existing PQRSmeasures. We appreciate the commenters’feedback but note, the suggested measureshave not been analyzed to determine thefeasibility of reporting these measurestogether within a measures group. Therefore,we are finalizing our proposal to remove theOsteporosis measures group from PQRS.N/A/N/A Effective Clinical CareOsteoporosis: Current Level of AlcoholUse and Advice on Potentially HazardousDrinking Prevention:Percentage of patientsABIM XCMS-1600-FC 1068

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsaged 18 and older with a diagnosis ofosteoporosis, osteopenia, or prior low impactfracture; women age 65 and older; or menage 70 and older whose current level ofalcohol use was documented and for thoseengaging in potentially hazardous drinkingwho received counseling within 12 monthsRationale:This measures group was deleteddue to the amount of measures that hadduplicative medical concepts within thePQRS program.Several commenters opposed the deletion ofall measures originally proposed to comprisethe Osteoporosis measures group.Commenters recommended theimplementation of a revised Osteoporosismeasures group utilizing six existing PQRSmeasures. We appreciate the commenters’feedback but note, the suggested measureshave not been analyzed to determine thefeasibility of reporting these measurestogether within a measures group. Therefore,we are finalizing our proposal to remove theCMS-1600-FC 1069

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsOsteporosis measures group from PQRS.N/A/N/A Patient SafetyOsteoporosis: Screen for Falls RiskEvaluation and Complete Falls RiskAssessment and Plan of Care:Percentageof patients aged 18 and older with adiagnosis of osteoporosis, osteopenia, orprior low impact fracture; women age 65 andolder; or men age 70 and older who had ascreen for falls risk evaluation within the past12 months and for those reported as having ahistory of two or more falls, or fall-relatedinjury who had a complete risk assessmentfor falls and a falls plan of care within thepast 12 monthsRationale:This measures group was deleteddue to the amount of measures that hadduplicative medical concepts within thePQRS program.Several commenters opposed the deletion ofall measures originally proposed to comprisethe Osteoporosis measures group.Commenters recommended theimplementation of a revised OsteoporosisABIM XCMS-1600-FC 1070

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsmeasures group utilizing six existing PQRSmeasures. We appreciate the commenters’feedback but note, the suggested measureshave not been analyzed to determine thefeasibility of reporting these measurestogether within a measures group. Therefore,we are finalizing our proposal to remove theOsteporosis measures group from PQRS.N/A/N/A Effective Clinical CareOsteoporosis: Dual-Emission X-rayAbsorptiometry (DXA) Scan:Percentage ofpatients aged 18 and older with a diagnosisof osteoporosis, osteopenia, or prior lowimpact fracture; women age 65 and older; ormen age 70 and older who had a DXA scanand result documentedRationale:This measures group was deleteddue to the amount of measures that hadduplicative medical concepts within thePQRS program.Several commenters opposed the deletion ofall measures originally proposed to comprisethe Osteoporosis measures group.Commenters recommended theABIM XCMS-1600-FC 1071

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsimplementation of a revised Osteoporosismeasures group utilizing six existing PQRSmeasures. We appreciate the commenters’feedback but note, the suggested measureshave not been analyzed to determine thefeasibility of reporting these measurestogether within a measures group. Therefore,we are finalizing our proposal to remove theOsteporosis measures group from PQRS.N/A/N/A Effective Clinical CareOsteoporosis: Calcium Intake Assessmentand Counseling:Percentage of patients aged18 and older with a diagnosis ofosteoporosis, osteopenia, or prior low impactfracture; women age 65 and older; or menage 70 and older who had calcium intakeassessment and counseling at least oncewithin 12 monthsRationale:This measures group was deleteddue to the amount of measures that hadduplicative medical concepts within thePQRS program.Several commenters opposed the deletion ofall measures originally proposed to compriseABIM XCMS-1600-FC 1072

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsthe Osteoporosis measures group.Commenters recommended theimplementation of a revised Osteoporosismeasures group utilizing six existing PQRSmeasures. We appreciate the commenters’feedback but note, the suggested measureshave not been analyzed to determine thefeasibility of reporting these measurestogether within a measures group. Therefore,we are finalizing our proposal to remove theOsteporosis measures group from PQRS.N/A/N/A Effective Clinical CareOsteoporosis: Vitamin D IntakeAssessment and Counseling:Percentage ofpatients aged 18 and older with a diagnosisof osteoporosis, osteopenia, or prior lowimpact fracture; women age 65 and older; ormen age 70 and older who had vitamin Dintake assessment and counseling at leastonce within 12 monthsRationale:This measures group was deleteddue to the amount of measures that hadduplicative medical concepts within thePQRS program.ABIM XCMS-1600-FC 1073

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsSeveral commenters opposed the deletion ofall measures originally proposed to comprisethe Osteoporosis measures group.Commenters recommended theimplementation of a revised Osteoporosismeasures group utilizing six existing PQRSmeasures. We appreciate the commenters’feedback but note, the suggested measureshave not been analyzed to determine thefeasibility of reporting these measurestogether within a measures group. Therefore,we are finalizing our proposal to remove theOsteporosis measures group from PQRS.N/A/N/A Effective Clinical CareOsteoporosis: Pharmacologic Therapy:Percentage of patients aged 18 and older witha diagnosis of osteoporosis, osteopenia, orprior low impact fracture; women age 65 andolder; or men age 70 and older who wereprescribed pharmacologic therapy approvedby the Food and Drug AdministrationRationale:This measures group was deleteddue to the amount of measures that hadduplicative medical concepts within thePQRS program.ABIM XCMS-1600-FC 1074

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsSeveral commenters opposed the deletion ofall measures originally proposed to comprisethe Osteoporosis measures group.Commenters recommended theimplementation of a revised Osteoporosismeasures group utilizing six existing PQRSmeasures. We appreciate the commenters’feedback but note, the suggested measureshave not been analyzed to determine thefeasibility of reporting these measurestogether within a measures group. Therefore,we are finalizing our proposal to remove theOsteporosis measures group from PQRS.N/A/N/A Effective Clinical CarePreventive Cardiology Composite: BloodPressure at Goal:Percentage of patients inthe sample whose most recent blood pressurereading was at goalRationale:This measures group was deleteddue to the amount of measures that hadduplicative medical concepts within thePQRS program.One commenter opposed the deletion of allABIM XCMS-1600-FC 1075

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsmeasures originally proposed to comprise thePreventive Cardiology measures group,disagreeing with CMS’ opinion that thismeasures group is duplicative of othermeasures. Specifically, the commenter’sconcern was that existing PQRS measuresonly address aspirin use among patientsdiagnosed with specific heart conditions.Weappreciate the commenter’s feedback, but weare not retaining the Preventive Cardiologymeasures group for reporting under PQRS.N/A/N/A Effective Clinical CarePreventive Cardiology Composite: LowDensity Lipids (LDL) Cholesterol at Goal:Percentage of patients in the sample whoseLDL cholesterol is considered to be at goal,based upon their coronary heart disease(CHD) risk factorsRationale:This measures group was deleteddue to the amount of measures that hadduplicative medical concepts within thePQRS program.One commenter opposed the deletion of allmeasures originally proposed to comprise theABIM XCMS-1600-FC 1076

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsPreventive Cardiology measures group,disagreeing with CMS’ opinion that thismeasures group is duplicative of othermeasures. Specifically, the commenter’sconcern was that existing PQRS measuresonly address aspirin use among patientsdiagnosed with specific heart conditions.Weappreciate the commenter’s feedback, but weare not retaining the Preventive Cardiologymeasures group for reporting under PQRS.N/A/N/A Effective Clinical CarePreventive Cardiology Composite: Timingof Lipid Testing Complies withGuidelines:Percentage of patients in thesample whose timing of lipid testingcomplies with guidelines (lipid testingperformed in the preceding 12-month period(with a three-month grace period) for patientswith known coronary heart disease (CHD)or CHD risk equivalent (prior myocardialinfarction (MI), other clinical CHD,symptomatic carotid artery disease,peripheral artery disease, abdominal aorticaneurysm, diabetes mellitus); or in thepreceding 24-month period (with a threemonth grace period) for patients with≥2 riskABIM XCMS-1600-FC 1077

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsfactors for CHD (smoking, hypertension, lowhigh density lipid (HDL), men≥45 years,women≥55 years, family history ofpremature CHD; HDL≥60 mg/dL acts as anegative risk factor); or in the preceding 60-month period (with a three-month graceperiod) for patients with≤1 risk factor forCHD)Rationale:This measures group was deleteddue to the amount of measures that hadduplicative medical concepts within thePQRS program.One commenter opposed the deletion of allmeasures originally proposed to comprise thePreventive Cardiology measures group,disagreeing with CMS’ opinion that thismeasures group is duplicative of othermeasures. Specifically, the commenter’sconcern was that existing PQRS measuresonly address aspirin use among patientsdiagnosed with specific heart conditions.We appreciate the commenter’s feedback,CMS-1600-FC 1078

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsbut, based on the rationale stated above, weare not retaining the Preventive Cardiologymeasures group for reporting under PQRS.N/A/N/A Effective Clinical CarePreventive Cardiology Composite:Diabetes Documentation or Screen Test:Percentage of patients in the sample who hada screening test for type 2 diabetes or had adiagnosis of diabetesRationale:This measures group was deleteddue to the amount of measures that hadduplicative medical concepts within thePQRS program.One commenter opposed the removal of thismeasure because they believe it has potentialto contribute to better outcomes for patientswith diabetes. Another commenter opposedthe deletion of all measures originallyproposed to comprise the PreventiveCardiology measures group, disagreeing withCMS’ opinion that this measures group isduplicative of other measures. Specifically,the commenter’s concern was that existingPQRS measures only address aspirin useABIM XCMS-1600-FC 1079

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsamong patients diagnosed with specific heartconditions.We appreciate the commenter’sfeedback, but we are not retaining thePreventive Cardiology measures group forreporting under PQRS.N/A/N/A Effective Clinical CarePreventive Cardiology Composite:Counseling for Diet and Physical Activity:Percentage of patients who received dietaryand physical activity counselingRationale:This measures group was deleteddue to the amount of measures that hadduplicative medical concepts within thePQRS program.One commenter opposed the deletion of allmeasures originally proposed to comprise thePreventive Cardiology measures group,disagreeing with CMS’ opinion that thismeasures group is duplicative of othermeasures. Specifically, the commenter’sconcern was that existing PQRS measuresonly address aspirin use among patientsdiagnosed with specific heart conditions.Weappreciate the commenter’s feedback, but weABIM XCMS-1600-FC 1080

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsare not retaining the Preventive Cardiologymeasures group for reporting under PQRS.N/A/N/A Effective Clinical CarePreventive Cardiology Composite:Correct Determination of Ten-Year Riskfor Coronary Death or MyocardialInfarction (MI):Number of patients in thesample whose ten-year risk of coronary deathor MI is correctly assessed and documentedRationale:This measures group was deleteddue to the amount of measures that hadduplicative medical concepts within thePQRS program.One commenter opposed the deletion of allmeasures originally proposed to comprise thePreventive Cardiology measures group,disagreeing with CMS’ opinion that thismeasures group is duplicative of othermeasures. Specifically, the commenter’sconcern was that existing PQRS measuresonly address aspirin use among patientsABIM XCMS-1600-FC 1081

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsdiagnosed with specific heart conditions.Weappreciate the commenter’s feedback, but weare not retaining the Preventive Cardiologymeasures group for reporting under PQRS.N/A/N/A Effective Clinical CarePreventive Cardiology Composite:Appropriate Use of Aspirin or OtherAntiplatelet/Anticoagulant Therapy:Percentage of patients in the sample who are:1) taking aspirin or otheranticoagulant/antiplatelet therapy, or 2)under age 30, or 3) age 30 or older and whoare documented to be at low risk. Low-riskpatients include those who are documentedwith no prior coronary heart disease (CHD)or CHD risk equivalent (prior myocardialinfarction (MI), other clinical CHD,symptomatic carotid artery disease,peripheral artery disease, abdominal aorticaneurysm, diabetes mellitus) and whose tenyear risk of developing CHD is < 10%Rationale:This measures group was deleteddue to the amount of measures that hadduplicative medical concepts within thePQRS program.ABIM XCMS-1600-FC 1082

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsOne commenter opposed the deletion of allmeasures originally proposed to comprise thePreventive Cardiology measures group,disagreeing with CMS’ opinion that thismeasures group is duplicative of othermeasures. Specifically, the commenter’sconcern was that existing PQRS measuresonly address aspirin use among patientsdiagnosed with specific heart conditions.Weappreciate the commenter’s feedback, but weare not retaining the Preventive Cardiologymeasures group for reporting under PQRS.N/A/N/A Effective Clinical CarePreventive Cardiology Composite:Smoking Status and Cessation Support:Percentage of patients in the sample whosecurrent smoking status is documented in thechart, and if they were smokers, weredocumented to have received smokingcessation counseling during the reportingperiodRationale:This measures group was deleteddue to the amount of measures that hadduplicative medical concepts within theABIM XCMS-1600-FC 1083

NQF/ PQRSNQS DomainMeasure Title and Description¥ Measure Steward Claims Registry EHR GPRO (Web Interface)* Measures Groups Oth er Q ua lit y Reporting Pro g ramsPQRS program.One commenter opposed the deletion of allmeasures originally proposed to comprise thePreventive Cardiology measures group,disagreeing with CMS’ opinion that thismeasures group is duplicative of othermeasures. Specifically, the commenter’sconcern was that existing PQRS measuresonly address aspirin use among patientsdiagnosed with specific heart conditions.Weappreciate the commenter’s feedback, but weare not retaining the Preventive Cardiologymeasures group for reporting under PQRS.¥ Measure details including titles, descriptions and measure owner information may vary during a particular program year. Thisis due to the timing of measurespecification preparation and the measure versions used by the various reporting options/methods. Please refer to the measure specifications that apply for eachof the reporting options/methods for specific measure details.

### CMS-1600-FC 1084

b. PQRS Measures Groups Section 414.90(b) defines a measures group as “a subset of four or more Physician Quality Reporting System measures that have a particular clinical condition or focus in common. The denominator definition and coding of the measures group identifies the condition or focus that is shared across the measures within a particular measures group.” In the CY 2014 PFS proposed rule, we proposed (7 8 FR 43448) to modify the minimum amount of measures that may be included in a PQRS measures group from four to six (78 FR 43448). Therefore, we proposed (78 FR 43448) to modify the definition of a measures group at §414.90(b) to indicate that a measures group would consist of at least six measures. Consequently, we propos ed (78 FR 43448) to add additional measures to each measures group that prev iously contained less than six measures (see Tables 31 through 56 at 78 FR 43449 thro ugh 43474). We solicited and recei ved the following public comments on these proposals:

Comment : Several commenters did not support our proposal to modify the definition of a measures group at §414.90(b) to indicate that a measur es group would consist of at least six measures. Commenters believed that the proposal to increase the minimum number of measures in a measures group from four to six measures seemed arbitrary. Some of these commenters suggested that the measures CMS proposed to add to measures groups that previously c ontained less than six measures were not appropriate to these measures groups as they did not address the speci fic clinical topic or condition addressed in the

measures groups. Response : We understand the commenters’ concerns re garding this proposal. Although we still plan to increase the minimum number of measures in a measures group in the future, we are not finalizing this proposal at this time. As such, we are not finalizing our proposals to add additional measures to measures groups that previously contained less than six measures. We will work with the measure developers and owners of these m easures groups to appropriately add measures to measures groups that only contain four measures within the measures group.

### CMS-1600-FC 1085

In addition, we solicited and received the fo llowing comment on our specific proposed measures

groups: Comment: Chronic Kidney Disease Measures Group - One commenter supported all proposed measures in the Chronic Kidney Disease (CKD) meas ures group as they represent important aspects of care that can delay CKD progression and protect patients from adverse outcomes. Response: Since we are not finalizing the proposal to increase the number of measures in a measures group from four to six, the Chronic Kidney Disease (CKD) measures group will remain as it was finalized in 2013. Therefore, we are not in cluding PQRS measure # 130: Documentation of Current Medications in the Medical Record and PQRS measu re #226: Preventive Care and Screening: Tobacco use: Screening and Cessation Intervention, in the measures group as proposed.

Comment: Hypertension Measures Group - One comme nter agrees with the Hypertension measures group but recommends replacing PQRS measu re #300 Hypertension: Blood Pressure Control, with PQRS measure #236 Hypertension: Controlli ng High Blood Pressure, citing the reason of the expanded age range to 90 as incons istent and creating confusion. Response : We appreciate the commenters’ feedback. However, we note that the age range of all of the measures within the Hypertension measures gr oup is 18 through 90, and the existing measures have been examined to determine the ability to report a nd analyze the measures contained within the measures group as a whole, whereas the suggested PQRS measu re has not been analyzed to determine the feasibility of reporting these measures together within a measures group.

Comment : Another commenter showed support for screening for chronic kidney disease in people with hypertension, but recommended replacing PQRS measure #297 Hypertension: Urine Protein Test and PQRS measure #298 Hypertension : Annual Serum Creatinine Test with a measure of documented

eGFR and urine albumin-creatinine ration. Response : CMS appreciates the commenters’ suggesti ons, but as the suggested changes to the measures group have not been analyzed, nor were they included in the CY2014 PFS proposed rule, CMS

### CMS-1600-FC 1086

is retaining the Hypertension measures group as it was finalized in the CY 2013 PFS final rule (77 FR 69272).

Comment : Cataracts Measures Group - Two commenters expressed concern with the proposed inclusion of Patient-Centered Surgical Risk Asse ssment and Communication in the Cataracts measures group, stating that this measure is not reportable for cataract surgeons. Response : Since we are not finalizing the proposal to increase the number of measures in a measures group from four to six, we are retaining the composition of the Cataracts measures group for 2014 as it was finalized in the CY 2013 PFS final rule ( 77 FR 69272). Therefore, we are not including PQRS measure # 130: Documentation of Current Me dications in the Medical Record, PQRS measure #226: Preventive Care and Screening: Tobacco use: Screening and Cessation Intervention, and PatientCentered Surgical Risk Assessment and Co mmunication in the measures group as proposed.

Comment : Sleep Apnea Measures Group - Several commenters support the Sleep Apnea measures group. There was however, concern regardi ng the addition of PQRS measures #128: Preventive Care and Screening: Body Mass Index (BMI) Sc reening and Follow-Up, # 130: Documentation of Current Medications in the Medical Record, and # 226: Preventive Care and Screening: Tobacco use: Screening and Cessation Intervention. Response : Since we are not finalizing the proposal to increase the number of measures in a measures group from four to six, we are retaining the Sleep Apnea measures group for 2014 as it was finalized in CY 2013 PFS final rule (77 FR 69272). Therefore, we are not including PQRS measures #128, #130 and #226 in the measures group as proposed.

Comment : Dementia Measures Group - Several comme nters expressed support for the retention of the Dementia measures group. One commenter ur ged that even though the measures are not NQFendorsed they are retained for continued use in PQ RS and other agency programs. One commenter did suggest the inclusion of three additional measur es: (1) a measure that requires physicians to assess cognitive impairment using a standardized assessment tool; (2) a measure that requires documentation of

### CMS-1600-FC 1087

a diagnosis in the medical record; and (3) the American Medical Association’s (AMA) dementia performance measure on palliative care c ounseling and advance care planning. Response : CMS appreciates the suggestions, however as previously stated, the existing measures have been examined to determine the ability to re port and analyze the measures contained within the measures group as a whole, whereas the suggested measu red have not been analyzed to determine the feasibility of reporting these measures together with in a measures group. Additionally, the suggested

measures were not included in the CY2014 PFS proposed rule. Therefore, CMS is retaining the Dementia measures group as it was finalized in the CY 2013 PFS final rule (77 FR 69272).

Comment : Perioperative Care Measures Group - Two commenters expressed concern with the proposed inclusion of the following measures in the Perioperative Care measures group: Patient-Centered Surgical Risk Assessment and Communication, PQRS measure # 130: Documentation of Current Medications in the Medical Record and PQRS measu re #226: Preventive Care and Screening: Tobacco use: Screening and Cessation Intervention. Response : Since we are not finalizing the proposal to increase the number of measures in a measures group from four to six, we are retaining the Perioperative Care measures group for 2014 as it was finalized in CY 2013 PFS final rule (77 FR 69272) . Therefore, we are not including Patient-Centered Surgical Risk Assessment and Communication, PQRS #130 and PQRS #226 in the measures group as proposed.

Comment : Ischemic Vascular Disease Measures Group - One commenter recommended not removing PQRS measure #201: Ischemic Vascular Disease (IVD): Blood Pressure Management from the IVD measures group without adding a measure fo cused on people with IVD. CMS appreciates the commenters’ suggestions, but disagrees due to CMS’ e fforts to reduce duplicity in measures and the fact that this measure was not proposed for inclusion in the CY2014 PFS proposed rule. One commenter agreed with the CMS proposal to revise the I schemic Vascular Disease measures group to include additional quality measures. CMS appreciates the comme nters’ support, but is not finalizing the proposal to increase the number of measures in a measures group from four to six.

### CMS-1600-FC 1088

Response : CMS is finalizing the Ischemic Vascular Disease measures group as it was finalized in CY 2013 PFS final rule (77 FR 6927 2), without PQRS measures #128: Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up and #130: Documentation of Current Medications in

the Medical Record.

Comment : Asthma Measures Group - One commenter noted that the Asthma measures group is an important measures group that is of interest to the pulmonary, critical care and sleep provider community. One commenter expressed concern with the inclusion of PQRS measures #110: Preventive Care and Screening: Influenza Im munization and #130: Documentation of Current Medications in the Medical Record, stating concern that is will creat e additional confusion for providers reporting on the

measure group. Response : Since we are not finalizing the proposal to increase the number of measures in a measures group from four to six, we are retaining the Asthma measures group for 2014 as it was finalized in CY 2013 PFS final rule (77 FR 69272) and not including PQRS #110 and PQRS #130 in the measures group as proposed.

Comment : Chronic Obstructive Pulmonary Disease (COPD) Measures Group - One commenter noted that the COPD measures group is an important me asures group that is of interest to the pulmonary, critical care and sleep provider community. Response : Since we are not finalizing the proposal to increase the number of measures in a measures group from four to six, we are retaining the COPD measures group for 2014 as it was finalized in CY 2013 PFS final rule (77 FR 69272) and not including PQRS #130 in the measures group as proposed.

Comment : Total Knee Replacement Measures Group - One commenter expressed support for the Total Knee Replacement measures group, including PQRS measures #130: Documentation of Current

Medications in the Medical Record and #226: Preven tive Care and Screening: Tobacco use: Screening and Cessation Intervention. They did suggest that in future year’s measure #226 be replaced with a

### CMS-1600-FC 1089

measure similar to the functional status assessment for knee replacement measure finalized in the EHR Incentive Program Stage 2 Final Rule. CMS appreciates the commenters’ suggestion. Response : Since we are not finalizing the proposal to increase the number of measures in a measures group from four to six, we are retaining the Total Knee Replacement measures group for 2014 as finalized in the CY 2013 PFS final rule (77 FR 69272), without PQRS #130 and PQRS #226 in the measures group as proposed.

Comment : General Surgery Measures Group - We received several comments supporting the inclusion of a General Surgery measures group. Response : Based on comments received and the decisi on to not finalize the proposal to increase the number of measures in a measures group from four to six, we are finalizing the General Surgery measures group for 2014, and not including PQRS measure # 130: Documentation of Current Medications in the Medical Record, PQRS measur e #226: Preventive Care in the measures group as proposed. Additionally, CMS has decided to combin e the proposed Gastrointestinal Surgery measures group with the General Surgery measures group to decr ease reporting burden on eligible professionals. The Iatrogenic Injury to Adjacent Organ/Structur e measure proposed for the General Surgery and Gastrointestinal Surgery measures groups is not being finalized.

Comment : Optimizing Patient Exposure to Ionizing Radiation Measures Group – Several commenters expressed support for this measures group, stating it will allow for more reporting opportunities for radiologists and will encourage phys icians to monitor and consider prior radiation exposure, in an effort to reduce unnecessary radi ation exposure to Medicare beneficiaries. One commenter agreed with the intent of the measures group but questioned the inclusion of the following measure: Count of Potential High Dose Radiation Imag ing Studies, and suggested replacing it with three existing PQRS measures: #322 Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Preoperative Evaluation in Low-Risk Surgery Pa tients, #323 Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Routine Testing After Pe rcutaneous Coronary Intervention (PCI) and #324 Cardiac Stress Imaging Not Meeting Appropriate Us e Criteria: Testing in Asymptomatic, Low-Risk

### CMS-1600-FC 1090

Patients. CMS appreciates the commenters’ sugges tions, but since we did not propose including these measures as part of the measures group in the CY 2014 PFS Proposed Rule, we are not addressing these

comments in this final rule. We received several comments supporting the Optimizing Patient Exposure to Ionizing Radiation Measures Group in general; however they encouraged CMS to finalize this measures group only after the individual measures have received NQF endorsement. Response : While we appreciate the commenters' feed back, we believe there are circumstances (such as when a measure addresses a gap in the PQRS measure set) where we may believe that it is important to include a non-NQF endorsed measure to be available for reporting under PQRS. Section 1848(k) (2) (C) (ii) of the Act authorizes the Secr etary to include measures available for reporting under PQRS that are not NQF endorsed. Therefore, we are finalizing the Optimizing Patient Exposure to Ionizing Radiation measures group with all of the proposed component measures for 2014.

Comment : Diabetes Measures Group - One commenter recommended not removing PQRS measure #3: Diabetes Mellitus: High Blood Pressure Control from the Diabetes measures group without adding a measure focused on blood pressure control for people with Diabetes. Response : CMS appreciates the commenters’ suggestions, but disagrees due to CMS’ efforts to reduce duplicity in measures and the fact that this measure was not proposed for inclusion in the CY2014 PFS proposed rule. Additionally, CMS is not fina lizing the proposal to increase the number of measures in a measures group from four to six. Therefore, CMS is finalizing the Diabetes measures group without PQRS measure #130: Documentation of Current Medications in the Medical Record. The following measures groups received no public comments:

● Back Pain Measures Group - measures #130 and #131 will not be finalized for inclusion in this measures group as proposed.

● Hepatitis C Measures Group - measures #130 and #2 26 will not be finalized for inclusion in this measures group as proposed.

● Heart Failure Measures Group - measures #128 and #130 will not be finalized for inclusion in this measures group as proposed.

### CMS-1600-FC 1091

● Coronary Artery Disease (CAD) Measur es Group - measures #128 and #130 will not be finalized for inclusion in this measures group as proposed.

● HIV/AIDS Measures Group – measure #130 will not be finalized for inclusion in this measures group as proposed.

● Inflammatory Bowel Disease Measures Group – this measures group is finalized as proposed.

● Cardiovascular Prevention Measures Group - this measures group is finalized as proposed.

● Oncology Measures Group - this me asures group is finalized as proposed.

● Preventive Care Measures Group - this measures group is finalized as proposed.

● Coronary Artery Bypass Graft Measures Group (CABG) - this measures group is finalized as proposed.

● Rheumatoid Arthritis (RA) Measures Group - this measures group is finalized as proposed. Tables 55 through 79 specify the final measures gr oups that are reportable for the PQRS for 2014 and beyond. Please note that, as we are not finalizing our proposal to modify the definition of a measures group to require that a measures group contain at least 6 measures, the measures groups we finalized in the CY 2013 PFS final rule (77 FR 69272) will re main unchanged. Please note that, since we are finalizing our proposal to eliminate the reporting of measures groups via claims, all measures groups in the 2014 Physician Quality Reporti ng System are reportable through registry-based reporting only. ¥ Measure details including titles, descriptions and meas ure owner information may vary during a particular program year. This is due to the timi ng of measure specification preparation and the measure versions used by the various reporting options/methods. Please refer to the meas ure specifications that apply for each of the reporting options/methods for specific measure details. TABLE 55: Diabetes Mellitus Measures Group NQF/ PQRS Measure Title and Description Measure Developer 0059/ 1 Diabetes: Hemoglobin A1c Poor Control: Percentage of patients 18-75 years of age with diabetes who had hemoglobin A1c > 9.0% during the measurement period NCQA

0064/ 2 Diabetes: Low Density Lipoprotein (LDL-C) Control (< 100 mg/dL): Percentage of patients 18–75 years of age with diabetes whose LDL-C was adequately controlled (< 100 mg/dL) during the measurement period NCQA

### CMS-1600-FC 1092

0055/ 117 Diabetes: Eye Exam: Percentage of patients 18 through 75 years of age with a diagnosis of diabetes (type 1 and type 2) who had a re tinal or dilated eye ex am in the measurement period or a negative retinal or dilated eye exam (negative for retinopathy) in the year prior to the measurement period NCQA

0062/ 119 Diabetes: Medical Attention for Nephropathy: The percentage of patients 18-75 years of age with diabetes who had a nephropathy screening test or evidence of nephropathy during the measurement period NCQA

0056/ 163 Diabetes: Foot Exam: Percentage of patients aged 18-75 years of age with diabetes who had a foot exam during the measurement period NCQA Finalized in the CY 2013 PFS final rule (see Table 97 at 77 FR 69273). TABLE 56: Chronic Kidney Disease (CKD) Measures Group NQF/ PQRS Measure Title and Description Measure Developer 0041/ 110 Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immuniza tion OR who reported previous receipt of an influenza immunization AMA-PCPI

1668/ 121 Adult Kidney Disease: Labora tory Testing (Lipid Profile): Percentage of patients aged 18 years and older with a diagnosis of chronic kidney disease (CKD) (stage 3, 4, or 5, not receiving Renal Replacement Therap y [RRT]) who had a fa sting lipid profile performed at least once within a 12-month period AMA-PCPI

AQA adopted/122 Adult Kidney Disease: Bl ood Pressure Management: Percentage of patient visits for those patients aged 18 years and older with a diagnosis of chronic kidney disease (CKD) (stage 3, 4, or 5, not receivi ng Renal Replacement Therapy [RRT]) and proteinuria with a blood pressure < 130/80 mmHg OR ≥ 130/80 mmHg with a documented plan of care AMA-PCPI

1666/ 123 Adult Kidney Disease: Patients On Er ythropoiesis-Stimulating Agent (ESA) - Hemoglobin Level > 12.0 g/dL: Percentage of calendar months within a 12-month period during which a hemoglobin level is measured for patients aged 18 years and older with a diagnosis of advanced chronic kidney disease (CKD) (stage 4 or 5, not receiving Renal Replacement Therapy [RRT]) or End Stage Renal Disease (ESRD) (who are on hemodialysis or periton eal dialysis) who are also receiving erythropoiesis-stimulating agent (ESA) therapy have a hemoglobin level > 12.0 g/dL AMA-PCPI

Finalized in the CY 2013 PFS final rule (see Table 98 at 77 FR 69273). TABLE 57: Preventive Care Measures Group NQF/ PQRS Measure Title and Description Measure Developer 0046/ 39 Screening or Therapy for Osteoporosis for Women Aged 65 Years and Older: Percentage of female patients aged 65 years and older who have a central dual-energy X- ray absorptiometry (DXA) measurement ordered or performed at least once since age 60 or pharmacologic therapy prescribed within 12 months AMA-PCPI/ NCQA

0098/ 48 Urinary Incontinence: Assessment of Presence or Absence of Urinary Incontinence in Women Aged 65 Years and Older: Percentage of female patients aged 65 years and older who were assessed for the presence or absence of urinary incontinence within 12 months AMA-PCPI/ NCQA

### CMS-1600-FC 1093

0041/ 110 Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization AMA-PCPI

0043/ 111 Pneumonia Vaccination Status for Older Adults : Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine NCQA

N/A/ 112 Breast Cancer Screening: Percentage of women 50 through 74 years of age who had a mammogram to screen for breas t cancer within 27 months NCQA

0034/ 113 Colorectal Cancer Screening: Percentage of patients 50 through 75 years of age who had appropriate screening for colorectal cancer NCQA

0421/ 128 Preventive Care and Screening: Body Mass Index (BMI) Screening and FollowUp: Percentage of patients aged 18 years and older with a documented BMI during the current encounter or duri ng the previous 6 months AND when the BMI is outside of normal parameters , a follow-up plan is documented during the encounter or during the previous 6 months of the encounter Normal Parameters: Age 65 years and older BMI > 23 and < 30; Age 18 – 64 years BMI ≥ 18.5 and < 25 CMS

AQA Adopted/ 173 Preventive Care and Screening: Un healthy Alcohol Use – Screening: Percentage of patients aged 18 years and older who were screened for unhealthy alcohol use using a systematic screening method within 24 months AMA-PCPI

0028/ 226 Preventive Care and Screening: Toba cco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user AMA-PCPI

Finalized in the CY 2013 PFS final rule (see Table 99 at 77 FR 69273). TABLE 58: Coronary Artery Bypass Graft (CABG) Measures Group

NQF/ PQRS Measure Title and Description Measure Developer

0134/ 43 Coronary Artery Bypass Graft (CABG): Use of Internal Mammary Artery (IMA) in Patients with Isolated CABG Surgery: Percentage of patients aged 18 years and older undergoing isolat ed CABG surgery who received an IMA graft STS

0236/ 44 Coronary Artery Bypass Graft (CABG): Preoperative Beta-Blocker in Patients with Isolated CABG Surgery: Percentage of isolated Coronary Artery Bypass Graft (CABG) surgeries for patients aged 18 y ears and older who received a beta-blocker within 24 hours prior to surgical incision CMS

0129/ 164 Coronary Artery Bypass Graft (CABG): Prolonged Intubation: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who require postoperative intubation > 24 hours STS

0130/ 165 Coronary Artery Bypass Graft (CABG): Deep Sternal Wound Infection Rate: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who, within 30 days postoperatively, develop deep sternal wound infection involving muscle, bone, and/or mediastinum requiring operative intervention STS

0131/ 166 Coronary Artery Bypass Graft (CABG): Stroke: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who have a postoperative stroke (i.e., any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain) that did not resolve within 24 hours STS

### CMS-1600-FC 1094

0114/ 167 Coronary Artery Bypass Graft (CABG): Postoperative Renal Failure: Percentage ofpatients aged 18 years and older undergoing isolated CABG surgery (without preexisting renal failure) who develop postoperative renal failure or require dialysis STS

0115/ 168 Coronary Artery Bypass Graft (CABG): Surgical Re-Exploration: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who require a return to the operating room (OR) during the curr ent hospitalization for mediastinal bleeding with or without tamponade, graf t occlusion, valve dysfunctio n, or other cardiac reason STS

0116/ 169 Coronary Artery Bypass Graft (CABG): An tiplatelet Medications at Discharge: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who were discharged on antiplatelet medication STS

0117/ 170 Coronary Artery Bypass Graft (CABG): Be ta-Blockers Administered at Discharge: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who were discharged on beta-blockers STS

0118/ 171 Coronary Artery Bypass Graft (CABG): Anti-Lipid Treatment at Discharge: Percentage of patients aged 18 years and older undergoing isolated CABG surgery who were discharged on a statin or other lipid-lowering regimen STS

Finalized in the CY 2013 PFS final rule (see Table 100 at 77 FR 69274). TABLE 59: Rheumatoid Arthritis (RA) Measures Group

NQF/ PQRS Measure Title and Description Measure Developer

0054/ 108 Rheumatoid Arthritis (RA): Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy: Percentage of patients aged 18 years and older who were diagnosed with RA and were prescribed, dispensed, or administered at least one ambulatory prescription for a DMARD NCQA

AQA adopted/176 Rheumatoid Arthritis (RA) : Tuberculosis Screening: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have documentation of a tuberculosis (TB) screening performed and results interpreted within 6 months prior to receiving a first course of therapy using a biologic diseasemodifying anti-rheumatic drug (DMARD) AMAPCPI

AQA adopted/177 Rheumatoid Arthritis (RA): Periodic Assessment of Disease Activity: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have an assessment and classification of disease activity within 12 months AMAPCPI AQA adopted/178 Rheumatoid Arthritis (RA): Functional Status Assessment: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) for whom a functional status assessment was perform ed at least once within 12 months AMAPCPI AQA adopted/179 Rheumatoid Arthritis (RA): Assessment and Classification of Disease Prognosis: Percentage of patients aged 18 years and olde r with a diagnosis of rheumatoid arthritis (RA) who have an assessment and classifi cation of disease prognosis at least once within 12 months AMAPCPI

AQA adopted/180 Rheumatoid Arthritis (RA): Glucocorticoid Management: Percentage of patients aged 18 years and older with a diagnosis of rheumatoid arthritis (RA) who have been assessed for glucocorticoid use and, for those on prolonged doses of prednisone ≥ 10 mg daily (or equivalent) with improvement or no change in disease activity, documentation of glucocorticoid management plan within 12 months AMAPCPI

Finalized in the CY 2013 PFS final rule (see Table 101 at 77 FR 69274).

### CMS-1600-FC 1095

TABLE 60: Perioperative Care Measures Group NQF/ PQRS Measure Title and Description Measure Developer 0270/ 20 Perioperative Care: Timing of Prophylact ic Parenteral Antibiotic – Ordering Physician: Percentage of surgical patients aged 18 years and older undergoing procedures with the indications for prophylactic parenteral antibiotics, who have an order for prophylactic parenteral antibiotic to be given within one hour (if fluoroquinolone or vancomycin, two hours), prior to the surgical incision (or start of procedure when no incision is required) AMA- PCPI/ NCQA

0268/ 21 Perioperative Care: Selection of Prophy lactic Antibiotic – First OR Second Generation Cephalosporin: Percentage of surgical patients aged 18 years and older undergoing procedures with the indications for a first OR second generation cephalosporin prophylactic antibiotic, who had an order for a first OR second generation cephalosporin for antimicrobial prophylaxis AMA- PCPI/ NCQA

0271/ 22 Perioperative Care: Discontinuation of Pr ophylactic Parenteral Antibiotics (NonCardiac Procedures): Percentage of non-cardiac surgical patients aged 18 years and older undergoing procedures with the indications for prophylactic parenteral antibiotics AND who received a prophylactic parenteral antibiotic, who have an order for discontinuation of prophylactic parenteral an tibiotics within 24 hours of surgical end time AMA- PCPI/ NCQA

0239/ 23 Perioperative Care: Venous Thromb oembolism (VTE) Prophylaxis (When Indicated in ALL Patients): Percentage of surgical patients aged 18 years and older undergoing procedures for which VTE prophylaxis is indicated in all patients, who had an order for Low Molecular Weight Heparin (LMWH), Low-Dose Unfractionated Heparin (LDUH), adjusted-dose warfarin, fondap arinux or mechanical prophylaxis to be given within 24 hours prior to incision time or within 24 hours after surgery end time AMA- PCPI/ NCQA

Finalized in the CY 2013 PFS final rule (see Table 102 at 77 FR 69275). TABLE 61: Back Pain Measures Group NQF/ PQRS Measure Title and Description Measure Developer 0322/ 148 Back Pain: Initial Visit: The percentage of patients aged 18 through 79 years with a diagnosis of back pain or undergoing back surgery who had back pain and function assessed during the initial visit to the clinician for the episode of back pain NCQA

0319/ 149/ Back Pain: Physical Exam: Percentage of patients aged 18 through 79 years with a diagnosis of back pain or undergoing back surgery who received a physical examination at the initial visit to the clinician for the episode of back pain NCQA

0314/ 150 Back Pain: Advice for Normal Activities: The percentage of patients aged 18 through 79 years with a diagnosis of back pain or undergoing back surgery who received advice for normal activities at the initial visit to the clinician for the episode of back pain NCQA

0313/ 151 Back Pain: Advice Against Bed Rest: The percentage of patients aged 18 through 79 years with a diagnosis of ba ck pain or undergoing back surgery who received advice against bed rest lasting four days or longer at the initial visit to the clinician for the episode of back pain NCQA

Finalized in the CY 2013 PFS final rule (see Table 103 at 77 FR 69275).

### CMS-1600-FC 1096

TABLE 62: Hepatitis C Measures Group NQF/ PQRS Measure Title and Description Measure Developer 0395/ 84 Hepatitis C: Ribonucleic Acid (RNA) Testing Before Initia ting Treatment: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C who started antiviral treatment within the 12 month reporting period for whom quantitative hepatitis C virus (HCV) RNA testing was performed within 12 months prior to initiation of antiviral treatment AMA-PCPI

0396/ 85 Hepatitis C: HCV Genotype Testing Prior to Treatment: Percentage of patients aged 18 years and older with a diagnosis of chro nic hepatitis C who started antiviral treatment within the 12 month reporting period for whom hepatitis C virus (HCV) genotype testing was performed within 12 months prior to initiation of antiviral treatment AMA-PCPI

0398/ 87 Hepatitis C: Hepatitis C Virus (HCV) Ri bonucleic Acid (RNA) Testing Between 4- 12 Weeks After Initia tion of Treatment: Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C who are receiving antiviral treatment for whom quantitative hepatitis C virus (HCV) RNA testing was performed between 4-12 weeks after the initiation of antiviral treatment AMA-PCPI

0399/ 183 Hepatitis C: Hepatitis A Vaccination in Patients with Hepatitis C Virus (HCV): Percentage of patients aged 18 years and older with a diagnosis of chronic hepatitis C who have received at least one injection of hepatitis A vaccine, or who have documented immunity to hepatitis A AMA-PCPI

Finalized in the CY 2013 PFS final rule (see Table 104 at 77 FR 69275). TABLE 63: Heart Failure (HF) Measures Group NQF/ PQRS Measure Title and Description Measure Developer 0081/ 5 Heart Failure (HF): Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Block er (ARB) Therapy for Left Ventricular Systolic Dysfunction (LVSD): Percentage of patients aged 18 years and older with a diagnosis of heart failure (HF) with a current or prior le ft ventricular ejection fraction (LVEF) < 40% who were prescribed ACE inhibitor or ARB therapy either within a 12 month period when seen in the outpatient setting OR at each hospital discharge AMA- PCPI/ ACCF/AHA

0083/ 8 Heart Failure (HF): Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD): Percentage of patients aged 18 years and older with a diagnosis of heart failure (HF) with a current or prior le ft ventricular ejection fraction (LVEF) < 40% who were prescribed beta-block er therapy either w ithin a 12 month period when seen in the outpatient setting OR at each hospital discharge AMA- PCPI/ ACCF/AHA

0079/ 198 Heart Failure: Left Ventricular Ejection Fraction (LVEF) Assessment: Percentage of patients aged 18 years and older with a diagnosis of heart failure for whom the quantitative or qualitative results of a recent or prior [any time in the past] LVEF assessment is documented within a 12 month period AMA- PCPI/ ACCF/AHA

0028/ 226 Preventive Care and Screening: Toba cco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user AMA-PCPI

Finalized in the CY 2013 PFS final rule (see Table 105 at 77 FR 69276).

### CMS-1600-FC 1097

TABLE 64: Coronary Artery Disease (CAD) Measures Group NQF/ PQRS Measure Title and Description Measure Developer 0067/ 6 Coronary Artery Disease (C AD): Antiplatelet Therapy: Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12 month period who were prescribed aspirin or clopidogrel AMA- PCPI/ ACCF/AHA

0074/ 197 Coronary Artery Disease (CAD): Lipid Control: Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12 month period who have a LDL-C result < 100 mg/dL OR patients who have a LDL-C result ≥ 100 mg/dL and have a documented plan of care to ac hieve LDL-C < 100 mg/dL, including at a minimum the prescription of a statin AMA- PCPI/ ACCF/AHA

0028/ 226 Preventive Care and Screening: Toba cco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user AMA-PCPI

N/A/ 242 Coronary Artery Disease (C AD): Symptom Management: Percentage of patients aged 18 years and older with a diagnosis of coronary artery disease seen within a 12 month period with results of an evaluation of level of activity and an assessment of whether anginal symptoms are present or absent with appropriate management of anginal symptoms within a 12 month period AMA- PCPI/ ACCF/ AHA

Finalized in the CY 2013 PFS final rule (see Table 106 at 77 FR 69276). TABLE 65: Ischemic Vascular Disease (IVD) Measures Group NQF/ PQRS Measure Title and Description Measure Developer 0068/ 204 Ischemic Vascular Disease (IVD): Use of Aspirin or Anoth er Antithrombotic: Percentage of patients 18 years of age and older who were discharged alive for acute myocardial infarction (AMI), coronary artery bypass graft (CABG) or percutaneous coronary interventions (PCI) in the 12 months prior to the measurement period, or who had an active diagnosis of ischemic vascul ar disease (IVD) during the measurement period and who had documentation of use of aspirin or another antithrombotic during the measurement period NCQA

0028/ 226 Preventive Care and Screening: Toba cco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user AMA-PCPI

0018/ 236 Controlling High Blood Pressure: Percentage of patients 18-85 years of age who had a diagnosis of hypertension and whose blood pressure was adequately controlled (< 140/90 mmHg) during the measurement period. NCQA

0075/ 241 Ischemic Vascular Disease (IVD): Comple te Lipid Profile and LDL-C Control (< 100 mg/dL): Percentage of patients 18 years of age and older who were discharged alive for acute myocardial infarction (AMI), coronary artery bypass graft (CABG) or percutaneous coronary interventions (PCI) in the 12 months prior to the measurement period, or who had an active diagnosis of is chemic vascular disease (IVD) during the measurement period, and who had each of the following during the measurement period: a complete lipid profile and LDL-C was adequately controlled (< 100 mg/dL) NCQA

Finalized in the CY 2013 PFS final rule (see Table 107 at 77 FR 69277).

### CMS-1600-FC 1098

TABLE 66: HIV/AIDS Measures Group NQF/ PQRS Measure Title and Description Measure Developer 0404/ 159 HIV/AIDS: CD4+ Cell Count or CD4+ Percentage Performed: Percentage of patients aged 6 months and older with a diagnosis of HIV/AIDS for whom a CD4+ cell count or CD4+ cell percentage was performed at least once every 6 months NCQA

0405/ 160 HIV/AIDS: Pneumocystis Jiroveci Pneumonia (PCP) Prophylaxis: Percentage of patients aged 6 weeks and older with a diagnosis of HIV/AIDS who were prescribed Pneumocystis Jiroveci Pn eumonia (PCP) prophylaxis NCQA

0409/ 205 HIV/AIDS: Sexually Transmitted Diseas e Screening for Chlamydia, Gonorrhea, and Syphilis: Percentage of patients aged 13 years and older with a diagnosis of HIV/AIDS for whom chlamydia, gonorrhea an d syphilis screenings were performed at least once since the diagnosis of HIV infection AMA- PCPI/ NCQA

2082/ N/A HIV Viral Load Suppression: The percentage of patients, regardless of age, with a diagnosis of HIV with a HIV viral load less than 200 copies/mL at last HIV viral load test during the measurement year HRSA

2083/ N/A Prescription of HIV An tiretroviral Therapy: Percentage of patients, regardless of age, with a diagnosis of HIV prescribed antiret roviral therapy for the treatment of HIV infection during the measurement year HRSA

2079/ N/A HIV Medical Visit Frequency: Percentage of patients, regardless of age with a diagnosis of HIV who had at least one medical visit in each 6 month period of the 24 month measurement period, with a minimum of 60 days between medical visits HRSA

2080/ N/A Gap in HIV Medical Visits: Percentage of patients, regardless of age, with a diagnosis of HIV who did not have a medical visit in the last 6 months HRSA Finalized in the CY 2013 PFS final rule (see Table 108 at 77 FR 69277). TABLE 67: Asthma Measures Group NQF/ PQRS Measure Title and Description Measure Developer 0047/ 53 Asthma: Pharmacologic Therapy for Persis tent Asthma - Ambulatory Care Setting: Percentage of patients aged 5 through 64 years with a diagnosis of persistent asthma who were prescribed long-term control medication AMA- PCPI/ NCQA

0001/ 64 Asthma: Assessment of Asthma Co ntrol – Ambulatory Care Setting: Percentage of patients aged 5 through 64 years with a diagnosis of asthma who were evaluated at least once during the measurement period for asthma control (comprising asthma impairment and asthma risk) AMA- PCPI/ NCQA

N/A/ 231 Asthma: Tobacco Use: Screening - Ambulatory Care Setting: Percentage of patients aged 5 through 64 years with a diagnosis of asthma (or their primary caregiver) who were queried about tobacco use and exposure to second hand smoke within their home environment at least once during the one-year measurement period AMA- PCPI/ NCQA

N/A/ 232 Asthma: Tobacco Use: Intervention - Ambulatory Care Setting: Percentage of patients aged 5 through 64 years with a di agnosis of asthma who were identified as tobacco users (or their primary caregiver) wh o received tobacco cessation intervention at least once during the one-year measurement period AMA- PCPI/ NCQA

Finalized in the CY 2013 PFS final rule (see Table 109 at 77 FR 69277).

### CMS-1600-FC 1099

TABLE 68: Chronic Obstructive Pulmona ry Disease (COPD) Measures Group NQF/ PQRS Measure Title and Description Measure Developer 0091/ 51 Chronic Obstructive Pulmonary Diseas e (COPD): Spirometry Evaluation: Percentage of patients aged 18 years and older with a diagnosis of COPD who had spirometry evaluation results documented AMA-PCPI

0102/ 52 Chronic Obstructive Pulmonary Dise ase (COPD): Inhaled Bronchodilator Therapy: Percentage of patients aged 18 years and older with a diagnosis of COPD and who have an FEV1/FVC less than 60% and have symptoms who were prescribed an inhaled bronchodilator AMA-PCPI

0041/ 110 Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit betwee n October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization AMA-PCPI

0043/ 111 Pneumonia Vaccination Status for Older Adults: Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine NCQA

0028/ 226 Preventive Care and Screening: Toba cco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user AMA-PCPI

Finalized in the CY 2013 PFS final rule (see Table 110 at 77 FR 69278). TABLE 69: Inflammatory Bowel Disease (IBD) Measures Group NQF/ PQRS Measure Title and Description Measure Developer 0028/ 226 Preventive Care and Screening: Toba cco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user AMA-PCPI

N/A/ 269 Inflammatory Bowel Disease (IBD): Type, Anatomic Location and Activity All Documented: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease who have documented the disease type, anatomic location and activity, at least once du ring the reporting period AGA

N/A/ 270 Inflammatory Bowel Disease (IBD): Preventive Care: Corticosteroid Sparing Therapy: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease who have been managed by corticosteroids greater than or equal to 10 mg/day for 60 or greater consecutive days that have been prescribed corticosteroid sparing therapy in the last reporting year AGA

N/A/ 271 Inflammatory Bowel Disease (IBD): Preventive Care: Corticosteroid Related Iatrogenic Injury – Bone Loss Assessment: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease who have received dose of corticosteroids greater than or equal to 10 mg /day for 60 or greater consecutive days and were assessed for risk of bone loss once per the reporting year AGA

### CMS-1600-FC 1100

N/A/ 272 Inflammatory Bowel Disease (IBD): Prev entive Care: Influenza Immunization: Percentage of patients aged 18 years and older with inflammatory bowel disease for whom influenza immuni zation was recommended, administ ered or previously received during the reporting year AGA

N/A/ 273 Inflammatory Bowel Disease (IBD): Preven tive Care: Pneumococcal Immunization: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease that had pneumococcal vaccination administered or previously received AGA

N/A/ 274 Inflammatory Bowel Disease (IBD): Test ing for Latent Tuberculosis (TB) Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease for whom a tuberculosis (TB) screening was performed and results interpreted within 6 months prior to receiving a first course of anti- TNF (tumor necrosis factor) therapy AGA

N/A/ 275 Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy: Percentage of patients aged 18 years and older with a diagnosis of inflammatory bowel disease (IBD) who had Hepatitis B Virus (HBV) status assessed and re sults interpreted within 1 year prior to receiving a first course of anti-TN F (tumor necrosis factor) therapy AGA

Finalized in the CY 2013 PFS final rule (see Table 111 at 77 FR 69278). TABLE 70: Sleep Apnea Measures Group NQF/ PQRS Measure Title and Description Measure Developer N/A/ 276 Sleep Apnea: Assessment of Sleep Symptoms: Percentage of visits for patients aged 18 years and older with a diagnosis of obstruc tive sleep apnea that includes documentation of an assessment of sleep symptoms, incl uding presence or absence of snoring and daytime sleepiness AMA- PCPI/ NCQA

N/A/ 277 Sleep Apnea: Severity Assess ment at Initial Diagnosis: Percentage of patients aged 18 years and older with a diagnosis of obstru ctive sleep apnea who had an apnea hypopnea index (AHI) or a respiratory disturbance index (RDI) measured at the time of initial diagnosis AMA- PCPI/ NCQA

N/A/ 278 Sleep Apnea: Positive Airway Pressure Therapy Prescribed: Percentage of patients aged 18 years and older with a diagnosis of moderate or severe obstructive sleep apnea who were prescribed positive airway pressure therapy AMA- PCPI/ NCQA

N/A/ 279 Sleep Apnea: Assessment of Adherence to Positive Airway Pressure Therapy: Percentage of visits for patients aged 18 years and older with a diagnosis of obstructive sleep apnea who were prescribed pos itive airway pressure therapy who had documentation that adherence to positive ai rway pressure therapy was objectively measured AMA- PCPI/ NCQA

Finalized in the CY 2013 PFS final rule (see Table 112 at 77 FR 69279). TABLE 71: Dementia Measures Group NQF/ PQRS Measure Title and Description Measure Developer N/A / 280 Dementia: Stagin g of Dementia: Percentage of patients, regardless of age, with a diagnosis of dementia whose severity of dementia was classified as mild, moderate or severe at least once within a 12 month period AMA-PCPI

### CMS-1600-FC 1101

N/A / 281 Dementia: Cognitive Assessment: Percentage of patients, regardless of age, with a diagnosis of dementia for whom an assessment of cognition is performed and the results reviewed at least once within a 12 month period AMA-PCPI

N/A / 282 Dementia: Functional Status Assessment: Percentage of patients, regardless of age, with a diagnosis of dementia for whom an assessment of functional status is performed and the results reviewed at leas t once within a 12 month period AMA-PCPI

N/A / 283 Dementia: Neuropsychiatr ic Symptom Assessment: Percentage of patients, regardless of age, with a diagnosis of dementia and for whom an assessment of neuropsychiatric symptoms is performed and results reviewed at least once in a 12 month period AMA-PCPI

N/A / 284 Dementia: Management of Ne uropsychiatric Symptoms: Percentage of patients, regardless of age, with a diagnosis of dementia who have one or more neuropsychiatric symptoms who received or were recomm ended to receive an intervention for neuropsychiatric symptoms within a 12 month period AMA-PCPI

N/A / 285 Dementia: Screening for Depressive Symptoms: Percentage of patients, regardless of age, with a diagnosis of dementia who were screened for depressive symptoms within a 12 month period AMA-PCPI

N/A / 286 Dementia: Counseling Regarding Safety Concerns: Percentage of patients, regardless of age, with a diagnosis of dementia or th eir caregiver(s) who were counseled or referred for counseling regarding safety concerns within a 12 month period AMA-PCPI

N/A / 287 Dementia: Counseling Regardi ng Risks of Driving: Percentage of patients, regardless of age, with a diagnosis of dementia or th eir caregiver(s) who were counseled regarding the risks of driving and the alternatives to driving at least once within a 12 month period AMA-PCPI

N/A / 288 Dementia: Caregiver Educ ation and Support: Percentage of patients, regardless of age, with a diagnosis of dementia whose caregiver(s) were provided with education on dementia disease management and health behavior changes AND referred to additional sources for support within a 12 month period AMA-PCPI

Finalized in the CY 2013 PFS final rule (see Table 113 at 77 FR 69279). TABLE 72: Parkinson’s Disease Measures Group NQF/ PQRS Measure Title and Description Measure Developer N/A / 289 Parkinson’s Disease: Annual Park inson’s Disease Diagnosis Review: All patients with a diagnosis of Parkinson’s disease who had an annual assessment including a review of current medications (e.g., medications that can produce Parkinson-like signs or symptoms) and a review for the presence of atypical features (e.g., falls at presentation and early in the disease course, poor respons e to levodopa, symmetry at onset, rapid progression [to Hoehn and Yahr stage 3 in 3 years], lack of tremor or dysautonomia) at least annually AAN

N/A / 290 Parkinson’s Disease: Psychiatric Diso rders or Disturbances Assessment: All patients with a diagnosis of Parkinson’s disease who were assessed for psychiatric disorders or disturbances (e.g., psychosis, depression, anxiety disorder, apathy, or impulse control disorder) at least annually AAN

N/A / 291 Parkinson’s Disease: Cognitive Impa irment or Dysfunction Assessment: All patients with a diagnosis of Parkinson’s disease wh o were assessed for cognitive impairment or dysfunction at least annually AAN

### CMS-1600-FC 1102

N/A / 292 Parkinson’s Disease: Querying about Sleep Disturbances: All patients with a diagnosis of Parkinson’s disease (or caregivers, as appropriate) who were queried about sleep disturbances at least annually AAN

N/A / 293 Parkinson’s Disease: Rehab ilitative Therapy Options: All patients with a diagnosis of Parkinson’s disease (or caregiver(s), as appropriate) who had rehabilitative therapy options (e.g., physical, occupational, or speech therapy) discussed at least annually AAN

N/A / 294 Parkinson’s Disease: Parkinson’s Disease Medical and Surgical Treatment Options Reviewed: All patients with a diagnosis of Park inson’s disease (or caregiver(s), asappropriate) who had the Parkinson’s disease treatment options (e.g., nonpharmacological treatment, pharmacological tr eatment, or surgical treatment) reviewed at least once annually AAN

Finalized in the CY 2013 PFS final rule (see Table 114 at 77 FR 69279). TABLE 73: Hypertension Measures Group NQF/ PQRS Measure Title and Description Measure Developer 0028/ 226 Preventive Care and Screening: Toba cco Use: Screening and Cessation Intervention: Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user AMA-PCPI

N/A/ 295 Hypertension: Use of Aspirin or Other Antithrombotic Therapy: Percentage of patients aged 30 through 90 years old with a diagnosis of hypertension and are eligible for aspirin or other antithrombotic therapy who were prescribed aspirin or other antithrombotic therapy ABIM

N/A/ 296 Hypertension: Complete Lipid Profile: Percentage of patients aged 18 through 90 years old with a diagnosis of hypertension who received a complete lipid profile within 60 months ABIM

N/A/ 297 Hypertension: Urine Protein Test: Percentage of patients aged 18 through 90 years old with a diagnosis of hypertension who either have chronic kidney disease diagnosis documented or had a urine protein test done within 36 months ABIM

N/A/ 298 Hypertension: Annual Serum Creatinine Test: Percentage of patients aged 18 through 90 years old with a diagnosis of hypertension who had a serum creatinine test done within 12 months ABIM

N/A/ 299 Hypertension: Diabetes Mellitus Screening Test: Percentage of patients aged 18 through 90 years old with a diagnosis of hypertension who had a diabetes screening test within 36 months ABIM

N/A/ 300 Hypertension: Blood Pressure Control: Percentage of patients aged 18 through 90 years old with a diagnosis of hypertension whose most recent blood pressure was under control (< 140/90 mmHg) ABIM

N/A/ 301 Hypertension: Low Density Li poprotein (LDL-C) Control: Percentage of patients aged 18 through 90 years old with a diagnosis of hypertension whose most recent LDL cholesterol level was under control (at goal) ABIM

N/A/ 302 Hypertension: Dietary and Physical Activity Modifications Appropriately Prescribed: Percentage of patients aged 18 through 90 years old with a diagnosis of hypertension who received dietary and physica l activity counseling at least once within 12 months ABIM

Finalized in the CY 2013 PFS final rule (see Table 115 at 77 FR 69280).

### CMS-1600-FC 1103

TABLE 74: Cardiovascular Prevention Measures Group NQF/ PQRS Measure Title and Description Measure Developer

0064/ 2 Diabetes: Low Density Lipoprotein (LDL-C) Control (< 100 mg/dL): Percentage of patients 18–75 years of age with diabetes whose LDL-C was adequately controlled (<100 mg/dL) during the measurement NCQA

0068/ 204 Ischemic Vascular Disease (IVD): Use of Aspirin or Anoth er Antithrombotic: Percentage of patients 18 years of age and older who were discharged alive for acute myocardial infarction (AMI), coronary artery bypass graft (CABG) or percutaneous coronary interventions (PCI) in the 12 months prior to the measurement period, or who had an active diagnosis of ischemic vascul ar disease (IVD) during the measurement period and who had documentation of use of aspirin or another antithrombotic during the measurement period NCQA

0028/ 226 Preventive Care and Screening: Toba cco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user AMA-PCPI

0018/ 236 Controlling High Blood Pressure: Percentage of patients 18-85 years of age who had a diagnosis of hypertension and whose blood pressure was adequately controlled (< 140/90 mmHg) during the measurement period. NCQA

0075/ 241 Ischemic Vascular Disease (IVD): Comple te Lipid Profile and LDL-C Control (< 100 mg/dL): Percentage of patients 18 years of age and older who were discharged alive for acute myocardial infarction (AMI), coronary artery bypass graft (CABG) or percutaneous coronary interventions (PCI) in the 12 months prior to the measurement period, or who had an active diagnosis of is chemic vascular disease (IVD) during the measurement period, and who had each of the following during the measurement period: a complete lipid profile and LDL-C was adequately controlled (< 100 mg/dL) NCQA

N/A/ 317 Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure (BP) AND a recommended follow-up plan is documented based on the curren t blood pressure reading as indicated CMS

Finalized in the CY 2013 PFS final rule (see Table 116 at 77 FR 69280). TABLE 75: Cataracts Measures Group NQF/ PQRS Measure Title and Description Measure Developer 0565/ 191 Cataracts: 20/40 or Better Visual Acuity within 90 Days Following Cataract Surgery: Percentage of patients aged 18 years and older with a diagnosis of uncomplicated cataract who had cataract surg ery and no significant ocular conditions impacting the visual outcome of surgery and had best-corrected visual acuity of 20/40 or better (distance or near) achieved within 90 days following the cataract surgery AMA- PCPI/ NCQA

### CMS-1600-FC 1104

0564/ 192 Cataracts: Complications within 30 Days Following Cataract Surgery Requiring Additional Surgic al Procedures: Percentage of patients aged 18 years and older with a diagnosis of uncomplicated cataract who had cataract surgery and had any of a specified list of surgical procedures in the 30 days following cataract surger y which would indicate the occurrence of any of the following major complications: retained nuclear fragments, endophthalmitis, dislocated or wrong pow er IOL, retinal detachment, or wound dehiscence AMA- PCPI/ NCQA

N/A/ 303 Cataracts: Improvement in Pa tient’s Visual Fu nction within 90 Days Following Cataract Surgery: Percentage of patients aged 18 years and older in sample who had cataract surgery and had improvement in visual function achieved within 90 days following the cataract surgery, based on completing a pre-opera tive and post-operative visual function survey AAO

N/A/ 304 Cataracts: Patient Satisfaction within 90 Days Following Cataract Surgery: Percentage of patients aged 18 years and older in sample who had cataract surgery and were satisfied with their care within 90 days following the cataract surgery, based on completion of the Consumer Assessment of Healthcare Providers an d Systems Surgical Care Survey AAO

Finalized in the CY 2013 PFS final rule (see Table 117 at 77 FR 69281). TABLE 76: Oncology Measures Group NQF/ PQRS Measure Title and Description Measure Developer 0387/ 71 Breast Cancer: Hormonal Therapy for Stage IC -IIIC Estrogen Receptor/Progesterone Receptor (E R/PR) Positive Breast Cancer: Percentage of female patients aged 18 years and older with Stage IC through IIIC, ER or PR positive breast cancer who were prescribed tamoxifen or aromatase inhibitor (AI) during the 12- month reporting period AMA-PCPI/ ASCO/NCCN

0385/ 72 Colon Cancer: Chemotherapy for AJCC Stage III Colon Cancer Patients: Percentage of patients aged 18 through 80 years with AJCC Stag e III colon cancer who are referred for adjuvant chemotherapy, prescribed adjuvant chemotherapy, or have previously received adjuvant chemotherapy within the 12-month reporting period AMA-PCPI/ ASCO/NCCN

0041/ 110 Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit betwee n October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization AMA-PCPI

0419/ 130 Documentation of Current Medica tions in the Medical Record: Percentage of visits for patients aged 18 years and older for which the eligible professional attests to documenting a list of current medications using all immediate resources available on the date of the encounter. This list mustinclude ALL known prescriptions, over-thecounters, herbals, and vitamin/mineral/dietary (nutritional) supplements AND must contain the medications’ name, dosage, frequency and route of administration. CMS

0384/ 143 Oncology: Medical and Radiation – Pain Intensity Quantified: Percentage of patients, regardless of patient age, with a diagnosis of cancer currently receiving chemotherapy or radiation therapy in which pain intensity is quantified AMA-PCPI

0383/ 144 Oncology: Medical and Radiation – Plan of Care for Pain: Percentage of visits for patients, regardless of age, with a diagnosi s of cancer currently receiving chemotherapy or radiation therapy who report having pain with a documented plan of care to address pain AMA-PCPI

### CMS-1600-FC 1105

0386/ 194 Oncology: Cancer Stage Documented: Percentage of patients, re gardless of age, with a diagnosis of cancer who are seen in the ambulatory setting who have a baseline American Joint Committee on Ca ncer (AJCC) cancer stage or documentation that the cancer is metastatic in the medical record at least once during the 12 month reporting period AMA- PCPI/ ASCO

0028/ 226 Preventive Care and Screening: Toba cco Use: Screening and Cessation Intervention: Percentage of patients 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user AMA-PCPI

Finalized in the CY 2013 PFS final rule (see Table 118 at 77 FR 69281). TABLE 77: Total Knee Replacement Measures Group NQF/ PQRS Measure Title Measure Developer N/A / N/A Total Knee Replacement: Sh ared Decision-Making: Tr ial of Conservative (Nonsurgical) Therapy: Percentage of patients regardless of age or gender undergoing a total knee replacement with documented shared decision-making with discussion of conservative (non-surgical) ther apy prior to the procedure AAHKS

N/A / N/A Total Knee Replacement: Venous Thromb oembolic and Cardiovascular Risk Evaluation: Percentage of patients regardless of age or gender undergoing a total knee replacement who are evaluated for the presen ce or absence of ven ous thromboembolic and cardiovascular risk factors within 30 days prior to the procedure including history of Deep Vein Thrombosis, Pulmonary Embolism, Myocardial Infarction, Arrhythmia and Stroke AAHKS

N/A / N/A Total Knee Replacement: Preoperative Antibiotic Infusion with Proximal Tourniquet: Percentage of patients regardless of age undergoing a total knee replacement who had the prophylactic antibiotic completely infused prior to the inflation of the proximal tourniquet AAHKS

N/A / N/A Total Knee Replacement: Identification of Implanted Prosthesis in Operative Report: Percentage of patients regardless of age or gender undergoing total knee replacement whose operative report identifie s the prosthetic implant specifications including the prosthetic implant manufacturer, the brand name of the prosthetic implant and the size of prosthetic implant AAHKS

Finalized in the CY 2013 PFS final rule (see Table 120 at 77 FR 69283). TABLE 78: General Surgery Measures Group NQF/ PQRS Measure Title Measure Developer N/A/ N/A Anastomotic Leak Intervention: Percentage of patients aged 18 years and older who required an anastomotic leak intervention following gastric bypass or colectomy surgery ACS

N/A/ N/A Unplanned Reoperation within the 30 Day Postoperative Period: Percentage of patients aged 18 years and older w ho had any unplanned reoperation within the 30 day postoperative period ACS

### CMS-1600-FC 1106

N/A/ N/A Unplanned Hospital Readmission within 30 Days of Principal Procedure: Percentage of patients aged 18 years a nd older who had an unplanned hospital readmission within 30 days of principal procedure ACS

N/A/ N/A Surgical Site Infection (SSI): Percentage of patients aged 18 years and older who had a surgical site infection (SSI) ACS

N/A/ N/A Patient-Centered Surgical Risk Assessment and Communication: Percentage of patients who underwent a non-emergenc y surgery who had their personalized risks of postoperative complications assessed by their surgical team prior to surgery using a clinical data-based, pa tient-specific risk calculator and who received personal discussion of those risks with the surgeon ACS

TABLE 79: Optimizing Patient Exposure to Ionizing Radiation Measures Group NQF/ PQRS Measure Title Measure Developer N/A/ N/A Optimizing Patient Exposure to Ionizing Ra diation: Utilization of a Standardized Nomenclature for Computed Tomography (CT) Imaging Description: Percentage of computed tomography (CT) imaging reports for all patients, regardless of age, with the imaging study named according to a standard ized nomenclature and the standardized nomenclature is used in institution’s computer systems AMA-PCPI

N/A/ N/A Optimizing Patient Exposure to Ionizing Ra diation: Count of Potential High Dose Radiation Imaging Studies: Computed Tomography (CT) and Cardiac Nuclear Medicine Studies: Percentage of computed tomography (CT) and cardiac nuclear medicine (myocardial perfusion studies) imaging reports for all patients, regardless of age, that document a count of known previous CT (any type of CT) and cardiac nuclear medicine (myocardial perfusion) studies th at the patient has received in the 12-month period prior to the current study AMA-PCPI

N/A/ N/A Optimizing Patient Exposure to Ionizing Ra diation: Reporting to a Radiation Dose Index Registry: Percentage of total computed tomography (CT) studies performed for all patients, regardless of age, that are repo rted to a radiation dose index registry AND that include at a minimum selected data elements AMA-PCPI

N/A/ N/A Optimizing Patient Exposure to Ionizing Radiation: Computed Tomography (CT) Images Available for Patient Fo llow-up and Comparison Purposes: Percentage of final reports for computed tomography (CT) studies performed for all patients, regardless of age, which document that Digital Imaging and Communications in Medicine (DICOM) format image data are available to non-affiliated external entities on a secure, media free, reciprocally searchable basis w ith patient authorization for at least a 12- month period after the study AMA-PCPI

N/A/ N/A Optimizing Patient Exposure to Ionizing Radiation: Search for Prior Computed Tomography (CT) Imaging Studies Thro ugh a Secure, Authorized, Media-Free, Shared Archive: Percentage of final reports of computed tomography (CT) studies performed for all patients, regardless of ag e, which document that a search for Digital Imaging and Communications in Medicine (D ICOM) format images was conducted for prior patient CT imaging studies completed at non-affiliated external entities within the past 12-months and are available through a s ecure, authorized, media free, shared archive prior to an imaging study being performed AMA-PCPI

### CMS-1600-FC 1107

N/A/ N/A Optimizing Patient Exposure to Ionizing Radiation: Appropriateness: Follow-up CT Imaging for Incidentally Detected Pulmonary Nodules According to Recommended Guidelines: Percentage of final reports for CT imaging studies of the thorax for patients aged 18 years and older with documented follow-up recommendations for incidentally detected pulmonary nodules (eg, follow-up CT imaging studies needed or that no follow-up is needed) based at a minimum on nodule size AND patient risk factors AMA-PCPI

c. Final Measures Available for Reporting in the GPRO Web Interface For ease of reference, Table 80 specifies the m easures that are available for reporting in the GPRO web interface for 2014 and beyond. Please note that this is a total list of the measures that will be reported by a group practice using the GPRO web inte rface in 2014, and all measures contained within this table were previously finalized in the CY 2013 PFS final rule (77 FR 69269). TABLE 80: Measures in the Group Practice Reporting Option Web Interface for 2014 and BeyondNQF/PQRS GPRO Disease Module NQS Domain Measure and Title Description ¥MeasureStewardOther QualityReportingPrograms

0059/ 1 Diabetes Mellitus Effective Clinical Care Diabetes: Hemoglobin A1c Poor Control: Percentage of patients 18-75 years of age with diabetes who had hemoglobin A1c > 9.0% during the measurement period NCQA MU2 ACO

0083/ 8 Heart Failure Effective Clinical Care Heart Failure (HF): BetaBlocker Therapy for Left Ventricular Systolic Dysfunction (LVSD): Percentage of patients aged 18 years and older with a diagnosis of heart failure (HF) with a current or prior left ventricular ejection fraction (LVEF) < 40%who were prescribed betablocker therapy either within a 12 month period when seen in the outpatient setting OR at each hospital discharge AMA- PCPI/ ACCF/ AHA MU2 ACO

### CMS-1600-FC 1108NQF/PQRS GPRO Disease Module NQS Domain Measure and Title Description ¥MeasureStewardOther QualityReportingPrograms

0097/ 46 Care Coordination/ Patient Safety Patient Safety Medication Reconciliation: Percentage of patients aged 65 years and older discharged from any inpatient facility (e.g. hospital, skilled nursing facility, or rehabilitation facility) and seen within 30 days following discharge in the office by the physician, prescribing practitioner, registered nurse, or clinical pharmacist providing on-going care who had a reconciliation of the discharge medications with the current medication list in the outpatient medical record documented AMA- PCPI/ NCQA ACO

0041/ 110 Preventive Care Community/Population Health Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization AMA-PCPI MU2 ACO

0043/ 111 Preventive Care Effective Clinical Care Pneumonia Vaccination Status for Older Adults: Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine NCQA MU2 ACO

N/A/ 112 Preventive Care Effective Clinical Care Breast Cancer Screening: Percentage of women 50 through 74 years of age who had a mammogram to screen for breast cancer within 27 months NCQA MU2 ACO

0034/ 113 Preventive Care Effective Clinical Care Colorectal Cancer Screening: Percentage of patients 50 through 75 years of age who had appropriate screening for colorectal cancer NCQA MU2 ACO

### CMS-1600-FC 1109NQF/PQRS GPRO Disease Module NQS Domain Measure and Title Description ¥MeasureStewardOther QualityReportingPrograms

0066/ 118 Coronary Artery Disease Effective Clinical Care Coronary Artery Disease(CAD): AngiotensinConverting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy -- Diabetes or Left Ventricular Systolic Dysfunction (LVEF < 40%): Percentage of patients aged 18 years and older with a diagnosis of coronary arte ry disease seen within a 12 month period who also have diabetes OR a current or prior Left Ventricular Ejection Fraction (LVEF) < 40% who were prescribed ACE inhibitor or ARB therapy AMAPCPI/ACCF/AHA ACO

0421/ 128 Preventive Care Community/Population Health Preventive Care and Screening: Body Mass Index(BMI) Screening and FollowUp: Percentage of patients aged 18 years and older with a documented BMI during the current encounter or during the previous 6 months AND when the BMI is outside of normal parameters, a follow-up plan is documented during the encounter or during the previous 6 months of the encounter Normal Parameters : Age 65 years and older BMI ≥ 23 and < 30; Age 18-64 years BMI ≥ 18.5 and < 25 CMS MU2 ACO

### CMS-1600-FC 1110NQF/PQRS GPRO Disease Module NQS Domain Measure and Title Description ¥MeasureStewardOther QualityReportingPrograms

0418/ 134 Preventive Care Community/Population Health Preventive Care and Screening: Screening for Clinical Depression and Follow-Up Plan : Percentage of patients aged 12 years and older screened for clinical depression on the date of the encounter using an age appropriate standardized depression screening tool AND if positive, a follow-up plan is documented on the date of the positive screen CMS MU2 ACO

0074/ 197 Coronary Artery Disease Effective Clinical Care Coronary Artery Disease (CAD): Lipid Control: Percentage of patients aged 18 years and older with a diagnosis of coronary arte ry disease seen within a 12 month period who have a LDL-C result < 100 mg/dL OR patients who have a LDL-C result ≥ 100 mg/dL and have a documented plan of care to achieve LDL-C < 100mg/dL, including at a minimum the prescription of a statin AMA- PCPI/ ACCF/ AHA ACO

### CMS-1600-FC 1111NQF/PQRS GPRO Disease Module NQS Domain Measure and Title Description ¥MeasureStewardOther QualityReportingPrograms

0068/ 204 Ischemic Vascular Disease Effective Clinical Care Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic: Percentage of patients 18 years of age and older who were discharged alive for acute myocardial infarction (AMI), coronary artery bypass graft (CABG) or percutaneous coronary interventions (PCI) in the 12 months prior to the measurement period, or who had an active diagnosis of ischemic vascular disease (IVD) during the measurement period and who had documentation of use of aspirin or another antithrombotic during the measurement period NCQA MU2 ACO Million Hearts

0028/ 226 Preventive Care Community/Population Health Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user AMA-PCPI MU2 ACO Million Hearts

0018/ 236 Hypertension Effective Clinical Care Controlling High Blood Pressure: Percentage of patients 18-85 years of age who had a diagnosis of hypertension and whose blood pressure was adequately controlled (< 140/90 mmHg) during the measurement period. NCQA MU2 ACO Million Hearts

### CMS-1600-FC 1112NQF/PQRS GPRO Disease Module NQS Domain Measure and Title Description ¥MeasureStewardOther QualityReportingPrograms

0075/ 241 Ischemic Vascular Disease Effective Clinical Care Ischemic Vascular Disease (IVD): Complete Lipid Profile and (LDL-C) Control (<100 mg/dL): Percentage of patients 18 years of age and older who were discharged alive for acute myocardial infarction (AMI), coronary artery bypass graft (CABG) or percutaneous coronary interventions (PCI) in the 12 months prior to the measurement period, or who had an active diagnosis of ischemic vascular disease (IVD) during the measurement period, and who had each of the following during the measurement period: a complete lipid profile and LDL-C was adequately controlled (< 100 mg/dL) NCQA MU2 ACO Million Hearts

N/A/ 317 Preventive Care Community/Population Health Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented: Percentage of patients aged 18 years and older seen during the measurement period who were screened for high blood pressure (BP) AND a recommended follow-up plan is documented based on the current blood pressure reading as indicated CMS MU2 ACO Million Hearts

0101/ 318 Care Coordination/ Patient Safety Patient Safety Falls: Screening for Fall Risk: Percentage of patients 65 years of age and older who were screened for future fall risk at least once during the measurement period NCQA MU2 ACO

### CMS-1600-FC 1113NQF/PQRS GPRO Disease Module NQS Domain Measure and Title Description ¥MeasureStewardOther QualityReportingPrograms

0729/ 319 Diabetes Mellitus Effective Clinical Care Diabetes Composite: Optimal Diabetes Care: Patients ages 18 through 75 with a diagnosis of diabetes, who meet all the numerator targets of this composite measure:

• A1c < 8.0%

• LDL < 100 mg/dL

• blood pressure < 140/90 mmHg

• tobacco non-user and

• (for patients with a diagnosis of ischemic vascular disease) daily aspirin use unless contraindicated MNCM ACO

¥ Titles and descriptions in this table are aligned with the 2014 Physician Quality Reporting System Claims and Registry measure titles and descriptions, and may differ from existing measures in other programs. Please reference the National Quality Forum (NQF) and Physician Qua lity Reporting System numbers for clarification. d. The Clinician Group (CG) Consumer Assessme nt of Healthcare Providers and Systems (CAHPS) Survey Because we believed these patient surveys are important tools for assessing beneficiary experience of care and outcomes, under our authority under section 1848(m)(3)(C) of the Act to select the measures for which a group practice must report, we proposed a new satisfactory reporting criterion in this the proposed rule to provide group practices comp rised of 25 or more eligible professionals the option to complete the CG CAHPS survey for purposes of satisfying the 2014 PQRS incentive and 2016 PQRS payment adjustment (78 FR 43476). Specifically, we proposed the following 12 summary the survey measures to use for the PQRS program:

● Getting timely care, appointments, and information.

● How well providers Communicate.

● Patient’s Rating of Provider.

● Access to Specialists.

### CMS-1600-FC 1114

● Health Promotion & Education.

● Shared Decision Making.

● Health Status/Functional Status.

● Courteous and Helpful Office Staff.

● Care Coordination.

● Between Visit Communication.

● Helping Your to Take Medication as Directed.

● Stewardship of Patient Resources. The first seven measures proposed above are the sa me ones used in the Medicare Shared Savings Programs. We believe it is important to align measures across programs to the extent possible. The remaining five measures proposed above address areas of high importance to Medicare and are areas where patient experience can inform the quality of care related to care coordination and efficiency. We noted that under this proposal, the group practice would bear the cost of having this survey administered. We solicited and received the following public comments on these proposed measures:

Comment : Several commenters generally supported the addition of a GPRO option to report the CG CAHPS survey measures for the 2014 PQRS incentiv e. However, some commenters have concerns that, since the survey’s questions fo cus on primary care issues, the surv eys are not widely applicable to services provided by certain specialists. Some of these commenters requested that, in addition to allowing reporting of the CG CAHPS survey measure s, surgical group practices in the GPRO also be allowed to report on the 

### Consumer Assessment of Healthcare Providers Surgical Care Survey ( SCAHPS) as these survey measures are more relevant to their practice. Response : We appreciate the commenters’ positive f eedback and are therefore finalizing this proposed criterion, as proposed. For the commenters’ request to allow surgical group practices to report on S-CAHPS survey measures, we generally agree that the S-CAHPS survey measures would be more relevant to a surgical group practice than the CG CAHPS measures. Unfortunately, at this time, we cannot introduce the S-CAHPS measures for reporting in the PQRS GPRO for 2014, since the Measure

### CMS-1600-FC 1115

Applications Partnership (MAP) has not yet had an o pportunity to review the S-CAHPS survey measures. Please note that section 1890A of the Act, which was added by section 3014(b) of the Affordable Care Act, requires that the entity with a contract with the Secretary under section 1890(a) of the Act (currently that, is the NQF) convene multi-stakeholder groups, cu rrently the MAP, to provide input to the Secretary on the selection of certain categories of quality and effici ency measures. As such, prior to inclusion in the PQRS measure set, the S-CAHPS survey measures must be submitted to the MAP for review.

Comment : One commenter expressed concern with “su rvey fatigue.” This commenter is concerned that some patients will receive multiple surveys asking very similar questions, which will likely to result in low response rates. Response : We appreciate the comment and concern raised regarding "survey fatigue." CMS recognizes that there are multiple CAHPS survey effo rts and takes steps to ensure that we are not duplicating patients in survey samples, as well as va ries the timing in which it disseminates the survey.

Based on the comments received and for the reasons stated previously, we are finalizing the CG CAHPS measures, as proposed. A full description of the CG CAHPS survey measures is available at http://acocahps.cms.gov/Content/Default.aspx#aboutSurvey

. 11. Statutory Requirements and Ot her Considerations for the Selection of PQRS Quality Measures for Meeting the Criteria for Satisfactory Participation in a Qualified Clinical Data Registry for 2014 and Beyond for Individual Eligible Professionals For the measures for which eligible professionals par ticipating in a qualified clinical data registry must report, section 1848(m)(3)(D) of the Act, as ame nded and added by section 601(b) of the American Tax Relief Act of 2012, provides that the Secretary shall treat eligible professionals as satisfactorily submitting data on quality measures if they satisfactorily participate in a qualified clinical data registry. Section 1848(m)(3)(E) of the Act, as added by sectio n 601(b) of the ATRA, provides some flexibility with regard to the types of measur es applicable to satisfactory participation in a qualified clinical data registry, by specifying that for measures used by a qua lified clinical data regist ry, sections 1890(b)(7) and

### CMS-1600-FC 1116

1890A(a) of the Act shall not apply, and measures endorsed by the entity with a contract with the Secretary under section 1890(a) of the Act may be used. We proposed to provide to qualified clinical data registries flexibility with regard to choosing the quality measures data available for individual eligib le professionals to choose from to report to CMS using these qualified clinical data registries (78 FR 43476). We believe it is pr eferable for the qualified clinical data registries with flexibility in selecting m easures since we believe these clinical data registries would know best what measures should be reported to achieve the goal of improving the quality of care furnished by their eligible professionals. Although we proposed to allow these clinical data registries to determine the quality measures from which individua l eligible professionals would choose to have reported to CMS, to ensure that CM S receives the same type of data that could be uniformly analyzed by CMS and sufficient measure data, we believe it is im portant to set parameters on the measures to be reported on and the types of measures should be reporte d to CMS. Therefore, we proposed requirements for the measures that would have to be reported to CMS by a qualified clinical data registry for the purpose of its individual eligible pr ofessionals meeting the criteria for sa tisfactory participation under the PQRS (78 FR 43476-43477). Below we have lis ted those proposed requirements and provided a summary of the comments received and our responses directly following each proposed requirement. We also received the following general comments on these proposals:

Comment : Several commenters generally supported our proposal to allow qualified clinical data registries to choose which measures will be reported to the PQRS on behalf of its participating eligible professional, as this provides flexibility in this reporting option. However, one commenter opposed allowing qualified clinical data registries to c hoose which measures its participants will report for purposes of the PQRS, because the measures reported by a qu alified clinical data registry on behalf of an eligible professional may not be as robust as the measures finalized in the PQRS measure set. Response : We appreciate the commenters’ positive feedb ack and agree that it provides flexibility. For the opposing comment, we understand the comment er’s concerns and expect that the measures reported by qualified clinical data registries are as robust and meaningful as those finalized in the PQRS

### CMS-1600-FC 1117

measure set. We are finalizing requirements – such as the requirements related to bench marking and the risk adjustment of certain measures – for the qualifie d clinical data registries that ensure that entities selected to become qualified clinical data regist ries have measures that are as robust as the measures contained in the PQRS measure set. Therefore, we believe our desire to provide flexibility in the measures that may be reported by a qualified clini cal data registry outweighs our concern that the measures reported by a qualified clinical data regist ry may not be as robust as the measures finalized in the PQRS measure set. We invited and received the following public comments on the proposed requirements for the measures the qualified clinical data registry would re port to CMS for the individual eligible professional:

● The qualified clinical data registry must have at least 9 measures, covering at least 3 of the 6 NQS domains, available for reporting. The 6 NQS domains are as follows: ++ Person and Caregiver-Cente red Experience and Outcomes

. These are measures that reflect the potential to improve patient-centered care and the quality of care delivered to patients. They emphasize the importance of collecting patient-repor ted data and the ability to impact care at the individual patient level, as well as the population le vel through greater involvement of patients and families in decision making, self-care, activation, and understanding of their health condition and its effective management. ++ Patient Safety

. These are measures that reflect the safe delivery of clinical services in both hospital and ambulatory settings and include processes that would reduce harm to patients and reduce burden of illness. These measures should enable long itudinal assessment of condition-specific, patientfocused episodes of care.

++ Communication and Care Coordination

. These are measures that demonstrate appropriate and timely sharing of information and coordination of clinical and preventive services among health professionals in the care team and with patients, car egivers, and families to improve appropriate and timely patient and care team communication.

### CMS-1600-FC 1118

++ Community/Population Health

. These are measures that reflect the use of clinical and preventive services and achieve improvements in the health of the population served. These are outcomefocused and have the ability to achieve longitudinal measurement that will dem onstrate improvement or lack of improvement in the health of the US population. ++ Efficiency and Cost Reduction

. These are measures that reflec t efforts to significantly improve outcomes and reduce errors. These measures also impact and benefit a large number of patients and emphasize the use of evidence to best manage hi gh priority conditions and determine appropriate use

of healthcare resources.

++ Effective Clinical Care

. These are measures that reflect clin ical care processes closely linked to outcomes based on evidence and practice guidelines.

We solicited and received the followi ng public comment on this proposal:

Comment : Some commenters supported our proposal to require that measures are reported according to their NQS domains. However, some comme nters suggested that we use domains created by AHRQ rather than the NQS domains. Response : We appreciate the commenters’ support. For the commenters who suggested that we use domains created by AHRQ, in an effort to alig n how these measures are analyzed, we prefer to use the NQS domains. Based on the comments received and since we are finalizing satisfactory participation criterion relating to the reporting of 9 measures cove ring at least 3 NQS domains, we are finalizing the requirement that a qualified clinical data registry must have at least 9 measures, covering at least 3 of the 6 NQS domains, available for reporting, as proposed.

● The qualified clinical data registry must have at least 1 outcome measure available for reporting, which is a measure that assesses the results of health care that are experienced by patients (that is, patients’ clinical events; patients’ recovery an d health status; patients’ experiences in the health system; and efficiency/cost). We solicited and r eceived the following public comment on this proposal:

Comment : Some commenters generally supportedthis proposal. Some commenters requested further clarification regarding the definition of an outcome measure.

### CMS-1600-FC 1119

Response : An outcome measure, as defined within the CMS Measures Management System Blueprint v10.0, indicates the result of the performance (or nonperformance) of functions or processes. It is a measure that focuses on achieving a particular state of health. PY 2014 examples of outcome measures within the PQRS include Measure #1: Diab etes: Hemoglobin A1c Poor Control, Measure #258: Rate of Open Repair of Small or Moderate Non-Ruptured Abdominal Aortic Aneurysms (AAA) without Major Complications (Discharged to Home by Post -Operative Day #7), or Measure #303: Cataracts: Improvement in Patient’s Visual Function w ithin 90 Days Following Cataract Surgery. Please note that, even though the one of the criteri on for satisfactory participation in a qualified clinical data registry does not require the reporting of at least 1 outcome measure, we are still finalizing this requirement, as proposed.

● The qualified clinical data registry may re port on process measures, which are measures that focus on a process which leads to a certain outcome, m eaning that a scientific basis exists for believing that the process, when executed well, will increase the probability of achieving a desired outcome. We solicited and received the following public comment on this proposal:

Comment : Some commenters generally supported this proposal. Response : We appreciate the commenters’ support for th is proposal. For the reasons stated above and based on the comments received, we ar e finalizing this requirement, as proposed.

● The outcome and process measures reported must contain denominator data. That is, the lower portion of a fraction used to calculate a rate, proportion, or ratio. The denominator must describe the population eligible (or episodes of care) to be evalua ted by the measure. This should indicate age, condition, setting, and timeframe (when applicable). For example, “Patients aged 18 through 75 years with a diagnosis of diabetes.” We solicited and r eceived the following public comment on this proposal:

Comment : Some commenters generally supported this proposal. Other commenters suggested that this requirement was overly restrictive. Th e commenters believed that qualified clinical data registries should be free to report on measures that do not conform to the way a PQRS measure is structured (such as requiring that measures contain denominator data).

### CMS-1600-FC 1120

Response : We appreciate the commenters’ support for this proposal. For commenters who believe that the qualified clinical data registries s hould be free to report on measures that do not conform to the PQRS measure structure, particularly cont aining denominator data, we agree that there are measures that are not structured like PQRS measur es that achieve the same goal as PQRS-structured measures of monitoring processes and outcomes. Howe ver, for CMS to be able to accept and analyze quality measures data, it is necessary that the measures follow a basic and familiar structure. Since we have had experience analyzing PQRS-structured measur es, it is necessary to implement restrictions on the structure of measures submitted by qualified clinical da ta registries. For the reasons stated above and based on the comments received, we are finalizing this requirement, as proposed.

● The outcome and process measures reported must contain numerator data. That is, the upper portion of a fraction used to calculate a rate, proporti on, or ratio. The numerator must detail the quality clinical action expected that satisfies the conditi on(s) and is the focus of the measurement for each patient, procedure, or other unit of measurement est ablished by the denominator (that is, patients who received a particular service or providers that comp leted a specific outcome/process). We solicited and received the following public comment on this proposal:

Comment : Some commenters generally supported this proposal. The commenters believed that qualified clinical data registries should be free to report on measures that do not conform to the way a PQRS measure is structured (such as requiring that measures contain numerator data). Response : We appreciate the commenters’ support for this proposal. For commenters who believe that the qualified clinical data registries s hould be free to report on measures that do not conform to the PQRS measure structure, particularly contai ning numerator data, we agree that there are measures that are not structured like PQRS measures that ach ieve the same goal as PQRS-structured measures of monitoring processes and outcomes. However, for CMS to be able to accept and analyze quality measures data, it is necessary that th e measures follow a basic and familiar structure. Since we have had experience analyzing PQRS-structured measures, it is necessary to implement restrictions on the structure

### CMS-1600-FC 1121

of measures submitted by qualified clinical data regist ries. For the reasons stated above and based on the comments received, we are finalizing this requirement, as proposed.

● The qualified clinical data registry must provide denominator exceptions for the measures, where appropriate. That is, those conditions that should remove a patient, procedure or unit of measurement from the denominator of the performance ra te only if the numerator criteria are not met. Denominator exceptions allow for adjustment of the cal culated score for those providers with higher risk populations. Denominator exceptions allow for the exercise of clinical judgment and should be specifically defined where capturing the information in a structured manner fits the clinical workflow. Generic denominator exception reasons used in meas ures fall into three general categories: Medical, Patient, or System reasons. We solicited and recei ved the following public comment on this proposal:

Comment : Some commenters generally supported this proposal. The commenters believed that qualified clinical data registries should be free to report on measures that do not conform to the way a PQRS measure is structured. Response : We appreciate the commenters’ support for this proposal. For commenters who believe that the qualified clinical data registries s hould be free to report on measures that do not conform to the PQRS measure structure, we agree that th ere are measures that are not structured like PQRS measures that achieve the same goal as PQRS-structured measures of monitoring processes and outcomes. However, for CMS to be able to accept and analy ze quality measures data, it is necessary that the

measures follow a basic and familiar structure. Sin ce we have had experience analyzing PQRS-structured measures, it is necessary to implement restrictions on the structure of measures submitted by qualified clinical data registries. For the reasons stated above and based on the comments received, we are finalizing this requirement, as proposed.

● The qualified clinical data registry must pr ovide denominator exclusions for the measures for which it will report to CMS, where appropriate. That is, those patients with conditions who should be removed from the measure population and denominator befo re determining if numerator criteria are met. (For example, Patients with bilateral lower extr emity amputations would be listed as a denominator

### CMS-1600-FC 1122

exclusion for a measure requiring foot exams.) We solicited and received the following public comment on this proposal:

Comment : Some commenters generally supported this proposal. . The commenters believed that qualified clinical data registries should be free to report on measures that do not conform to the way a PQRS measure is structured. Response : We appreciate the commenters’ support for this proposal. For commenters who believe that the qualified clinical data registries s hould be free to report on measures that do not conform to the PQRS measure structure, we agree that th ere are measures that are not structured like PQRS measures that achieve the same goal as PQRS-structured measures of monitoring processes and outcomes. However, for CMS to be able to accept and analy ze quality measures data, it is necessary that the

measures follow a basic and familiar structure. Sin ce we have had experience analyzing PQRS-structured measures, it is necessary to implement restrictions on the structure of measures submitted by qualified clinical data registries. For the reasons stated above and based on the comments received, we are finalizing this requirement, as proposed.

● The qualified clinical data registry must provide to CMS descriptions for the measures for which it will report to CMS by no later than March 31, 2014. The descriptions must include: name/title of measures, NQF # (if NQF endorsed), descriptions of the denominator, numerator, and when applicable, denominator exceptions and denominator exclusions of the measure. We solicited and received public comment on this proposal:

Comment : Some commenters generally supported this proposal. Response : We appreciate the commenters’ support for th is proposal. For the reasons stated above and based on the comments received, we ar e finalizing this requirement, as proposed. We note that last year we introduced the repor ting of composite measures in the PQRS measure set. While we have had years of experience analyzing measures structured like traditional PQRS measures, we are only in the initial stages of learning how to analyze composite measures. To the extent that we qualified clinical data registries wish to submit composite measures for reporting for the PQRS,

### CMS-1600-FC 1123

we are requiring that the qualified clinical data registry calculate the composite score for CMS and provide to CMS the formula used for calculating the composite score. It is necessary that qualified clinical data registries be able to calculate the co mposite score, as well as provide us with their formula for calculating the score as CMS will likely be una ble to analyze the data received on composite

measures. Please note that we are specifying the final re quirements we are adopting regarding quality measures for satisfactory participation in a qualif ied clinical data registry under §414.90(g). 12. PQRS Informal Review Section 414.90(j) provides that eligible professiona ls and group practices may request an informal review of the determination that an eligible prof essional or group practice did not satisfactorily submit data on quality measures under the PQRS. Because we be lieve it is important to also allow eligible professionals who attempt to satisfactorily participate in a qualified clinical data registry to be able to request an informal review of the determination that the eligible professional satisfactorily participated in a qualified clinical data registry, we proposed to modify §414.90(j) to allow individual eligible professionals who attempt to satisfactorily participate in a qualified clinical data registry the opportunity to request an informal review. We solicite d and received public comment on this proposal:

Comment : Several commenters supported our proposal to modify §414.90(j) to allow individual eligible professionals who attempt to satisfactorily pa rticipate in a qualified clinical data registry the opportunity to request an informal review. Response : Based on the commenters’ positive feedback and for the reasons we set forth above, we are finalizing this proposal, as proposed. We ar e therefore modifying newly designated §414.90(m) to specify allowing individual eligible professionals who attempt to satisfactorily participate in a qualified clinical data registry the opportuni ty to request an informal review.

### CMS-1600-FC 1124

I. Electronic Health Record (EHR) Incentive Program The HITECH Act (Title IV of Division B of the A RRA, together with Title XIII of Division A of the ARRA) authorizes incentive payments under Medicar e and Medicaid for the adoption and meaningful use of certified EHR technology (CEHRT). Secti on 1848(o)(2)(B)(iii) of the Act requires that in selecting clinical quality measures (CQMs) for elig ible professionals (EPs) to report under the EHR Incentive Program, and in establishing the form and manne r of reporting, the Secretary shall seek to avoid redundant or duplicative reporting otherwise required. As such, we have taken steps to establish alignments among various quality re porting and payment programs that include the submission of CQMs. For CY 2012 and subsequent years, §495.8(a)(2 )(ii) requires an EP to successfully report the clinical quality measures selected by CMS to CMS or the states, as applicable, in the form and manner specified by CMS or the states, as applicable. In the EHR Incentive Program Stage 2 Final Rule, we established clinical quality measure reporting options for the Medicare EHR Incentive Program for CY 2014 and subsequent years that include one individua l reporting option that aligns with the PQRS’s EHR reporting option (77 FR 54058) and two group reporti ng options that align with the PQRS GPRO and Medicare Shared Savings Program (MSSP) and Pione er ACOs (77 FR 54076 to 54078). In the CY 2014 PFS proposed rule, we proposed two additional aligne d options for EPs to report CQMs for the Medicare EHR Incentive Program for CY 2014 and subsequent year s with the intention of minimizing the reporting burden on EPs (78 FR 43479-43481). Please note that, during the comment period following the proposed rule, we received comments that were not related to our specific proposals for the EHR Incentive Program in the CY 2014 PFS proposed rule. While we appreciate the commenters’ feedback, these comments will not be specifically addressed in this CY 2014 PFS final rule with comment period, as they are beyond the scope of this rule. 1. Qualified Clinical Data Registry Reporting Option For purposes of meeting the CQM reporting component of meaningful use for the Medicare EHR Incentive Program for the EHR reporting periods in 2 014 and subsequent years, we proposed to allow

### CMS-1600-FC 1125

EPs to submit CQM information using qualified c linical data registries, according to the proposed definition and requirements for qualified clinical data registries under the PQRS (78 FR 43360). We refer readers to the discussion in the propo sed rule for further explanation of the PQRS qualified clinical data registry reporting option and the reasons given in support of our proposals (78 FR 43479). In addition to the criteria that are ultimately established for PQRS, we proposed the following additional criteria that an EP who seeks to report CQMs for the Medicare EHR Incentive Program using a qualified clinical data registry must satisfy: (1 ) the EP must use CEHRT as required under the Medicare EHR Incentive Program; (2) the CQMs reported must be included in the Stage 2 final rule (see Table 8, 77 FR 54069) and use the same electronic specifica tions established for the EHR Incentive Program; (3) report 9 CQMs covering at least 3 domains; (4) if an EP’s CEHRT does not contain patient data for at least 9 CQMs covering at least 3 domains, then the EP must report the CQMs for which there is patient data and report the remaining CQMs as “zero denominators” as displayed by the EP’s CEHRT; and (5) an

EP must have CEHRT that is certified to all of th e certification criteria required for CQMs, including certification of the qualified clinical data registry itself for the functions it will fulfill (for example, calculation, electronic submission). We noted that these proposed additional criteria are already final policies for the CQM reporting options that we establi shed for EPs in the EHR Incentive Program Stage 2

final rule. We referred readers to that final rule fo r further explanation of the policies related to clinical quality measure reporting under the EHR Incentive Program (77 FR 54049-54089). The electronic specifications for the clinical quality measures can be found at http://www.cms.gov/Regulations-andGuidance/Legislation/EHRIncentiv ePrograms/eCQM_Library.html

. We proposed the qualified clinical data regist ry reporting option only for those EPs who are beyond their first year of demonstrating meaningful use (MU). For purposes of avoiding a payment adjustment under Medicare, EPs who are in their first year of demonstrating MU in the year immediately preceding a payment adjustment year must satisfy their CQM reporting requirements by October 1 of such preceding year (for example, by October 1, 2014 to avoid a payment adjustment in 2015). We noted that the proposed qualified clinical data registry reporting option would not enable an EP to meet the

### CMS-1600-FC 1126

deadline to avoid a payment adjustment because th ese qualified clinical data registries would be submitting data on CQMs by the last day of Fe bruary following the 2014 PQRS incentive reporting periods, which would occur after October 1, 2013. Therefore, EPs who are first-time meaningful EHR users must report CQMs via attestation as established in the EHR Incentive Program Stage 2 final rule (77 FR 54050). The reporting periods established in the EHR Incentive Program Stage 2 final rule would continue to apply to EPs who would choose to repo rt CQMs under this proposed qualified clinical data registry reporting option for purposes of the Medi care EHR Incentive Program (77 FR 54049-54051). We noted that this may not satisfy requirements for other quality reporting programs that have established 12-month reporting periods, such as the PQRS. As EPs are required to use CEHRT under section 184 8(o)(2)(A)(iii) of the Act, we proposed that, for the Medicare EHR Incentive Program, an EP who seek s to report using a qualified clinical data registry that meets the criteria established for PQRS mu st also ensure that the registry selected is certified for the functionality that it is intended to fulfill a nd is a certified EHR Module that is part of the EP’s

CEHRT. We solicited and received the following public comments on these proposals:

Comment : One commenter opposed our general proposal to allow EPs to submit CQM information using qualified clinical data registries, according to the definition and requirements for qualified clinical data registries under the PQRS. Th e commenter indicated that incorporating a qualified clinical data registry option for the EHR Incentiv e Program would undermine the integrity of the requirements to meet the CQM component of meaningf ul use. Specifically, the commenter believed the proposed requirements to participate in a qualified c linical data registry were less stringent than the requirements finalized in the EHR Incentive Program Stage 2 final rule with regard to CQM reporting. Response : We disagree with the commenter’s concerns and do not believe the qualified clinical data registry option would be less stringent than the other reporting options already established in the EHR Incentive Program Stage 2 final rule. To th e contrary, as discussed above, we proposed certain additional requirements for EPs who report using a qu alified clinical data registry for purposes of the

### CMS-1600-FC 1127

Medicare EHR Incentive Program, which were establishe d previously for other reporting methods in the EHR Incentive Program Stage 2 final rule, such as th e requirement that an EP that reports using a qualified clinical data registry must use a product that is CEHRT.

Comment : Several commenters opposed our proposed requirement to only allow reporting of the CQMs included in the Stage 2 final rule (see Table 8, 77 FR 54069), as well as to use the same electronic specifications established for the EHR Incentive Prog ram. The commenters believed EPs should be allowed to report on measures outside of the CQMs in cluded in the Stage 2 final rule to align with the reporting criteria finalized under the PQRS that allo ws qualified clinical data registries to report on measures outside the PQRS and EHR Incentive Program measure set. Response : We understand the commenters’ desire to cr eate flexibility in the measures that may be reported under this qualified clini cal data registry option. However, the CQMs selected for the EHR Incentive Program were established in the Stage 2 final rule prior to the passage of the American Taxpayer Re lief Act of 2012, and we ha ve not proposed to add additional measures to that set. Therefore, we are fi nalizing this proposal. Please note that, in addition, as we also finalized for EPs using the qualified clinic al data registry reporting mechanism for the PQRS, an EP who chooses to report using a qualified clini cal data registry to meet the CQM component of meaningful use in 2014 must report the most recent version (that is, the June 2013 version) of the electronic specification of the measures. The ex ception to this policy is for the measure CMS140v2, Breast Cancer Hormonal Therapy for Stage IC-IIIC Estrogen Receptor/Progesterone Receptor (ER/PR) Positive Breast Cancer (NQF 0387). As explained belo w, since CMS discovered an error in this measure, EPs reporting this measure must use the December 2012 version of this CQM.

We understand the commenters’ desire to allo w more flexibility in reporting via a qualified clinical data registry and, in the future, we will wo rk towards developing a more flexible program policies and certification criteria that would allow eCQMs deve loped by QCDRs to be reported to CMS in future rulemaking.

### CMS-1600-FC 1128

Comment : The majority of the commenters supported this proposal. Many of these commenters were pleased to see a qualified clinical data regist ry reporting option for the EHR Incentive Program that aligns with the qualified clinical data registry option for the PQRS. Response : We appreciate the commenters’ positive feedback.

Comment : Some commenters opposed our proposed re quirement that an EP who seeks to report using a qualified clinical data registry that meets the criteria established for PQRS must also ensure that the registry selected is certified for the functionality that it is intended to fulfill and is a certified EHR Module that is part of the EP’s CEHRT. Some of these commenters believe this requirement would bring the qualified clinical data registry option for the EH R Incentive Program out of alignment with the PQRS qualified clinical data registry option for 2014. Response : Indeed, this additional requirement depa rts from the product and vendor requirements for a qualified clinical data registry for the PQRS in 2014. However, as we noted in the CY 2014 PFS proposed rule, under section 1848(o)(2)(A)(iii) of th e Act, EPs are required to use CEHRT to submit information on clinical quality measures for the EH R Incentive Program. The 2014 Edition certification criteria established by the ONC set the requirements fo r certification that cover the functionality needed to “capture and export” (45 CFR 170. 314(c)(1)), “import and calculate” (45 CFR 170.314(c)(2)), and for “electronic submission” (45 CFR 170.314(c)(3)) of each CQM that will be reported. In order for the EP’s CEHRT to meet these criteria, the qualified clinical da ta registry would need to test and certify to the functionality that it will fulfill for the EP’s CQM repo rting, and the qualified clinical data registry’s certified module would need to be part of the EP’s CEHRT. After consideration of the public comments receive d, we are finalizing as proposed our proposal to allow EPs to submit CQM information for purpo ses of the Medicare EHR Incentive Program beginning with the reporting periods in 2014 using qualified clinical data regist ries, according to the definition and requirements for qualified clinical data registries under the PQRS discussed in section IV.I. of this final rule with comment period and with the additiona l criteria for the EHR Incentive Program discussed

### CMS-1600-FC 1129

above. We are finalizing this reporting option only for EPs who are beyond their first year of demonstrating meaningful use. The registry will need to be certified for the CQM criteria listed at 45 CFR 170.314(c)(2) (“import and calculate”) for each CQM that will be submitted and 45 CFR 170.314(c)(3) (“electronic submission”). EPs will still need to include a certif ied EHR Module as part of their CEHRT that is certified to the CQM criteria listed at 45 CFR 170.314(c )(1) (“capture and export”) for each of the CQMs that would be submitted to CMS for the purposes of meeting the CQM requirements of the Medicare EHR Incentive Program. If the qualified clinical data re gistry is performing the function of data capture for the CQMs that would be submitted to CMS, then the registry would need to be certified to the “capture and export” criteria listed at 45 CFR 170.314(c )(1)., and the certified EHR Module must be part of the EP’s CEHRT. Please note that, similar to what is finalized for the PQRS in this final rule with comment period, a qualified clinical data registry wo uld be required to submit quality measures data in a QRDA-III format as proposed (78 FR 43480) and finalized in this final rule with comment period. Although we mentioned allowing for submission of qu ality measures data in a QRDA-I format, we are not finalizing the proposal to allow for submis sion of quality measures data in a QRDA-I format. 2. Group Reporting Option – Comp rehensive Primary Care Initiative The Comprehensive Primary Care (CPC) Initiative, under the authority of section 3021 of the Affordable Care Act, is a multi-payer initiative fost ering collaboration between public and private health care payers to strengthen primary care. Under this initiative, CMS will pay participating primary care practices a care management fee to support enhanced , coordinated services. Simultaneously, participating commercial, State, and other federal insurance plan s are also offering support to primary care practices that provide high-quality primary care. There are ap proximately 500 CPC participants across 7 health

care markets in the U.S. More details on the CPC Initiative can be found at http://innovation.cms.gov/initiatives/Comprehens ive-Primary-Care-Initiative/index.html

. Under the CPC Initiative, CPC practice sites are re quired to report to CMS a subset of the CQMs that were selected in the EHR Incentive Program St age 2 final rule for EPs to report under the EHR

### CMS-1600-FC 1130

Incentive Program beginning in CY 2014 (77 FR 54069-54 075). In a continuing effort to align quality reporting programs and innovation initiatives, we pr opose to add a group reporting option for CQMs to the Medicare EHR Incentive Program beginning in CY 2014 for EPs who are part of a CPC practice site that successfully submits at least 9 electronically sp ecified CQMs covering 3 domains. We proposed that each of the EPs in the CPC practice site would satis fy the CQM reporting component of meaningful use for the relevant reporting period if the CPC practice site successfully submits and meets the reporting requirements of the CPC Initiative. We proposed that only those EPs who are beyond their first year of demonstrating meaningful use may use this prop osed CPC group reporting option, for the reasons explained in the preceding section in regard to avoi ding a payment adjustment under Medicare. We proposed that EPs who successfully submit as part of a CPC practice site in accordance with the requirements established for the CPC Initiative and using CEHRT would satisfy their CQM reporting requirement for the Medicare EHR Incentive Program. If a CPC practice site fails the requirements estab lished for the CPC Initiative, we noted that the EPs who are part of the site would have the opp ortunity to report CQMs per the requirements and deadlines established in the EHR Incentive Program Stag e 2 final rule for EPs to report under the EHR Incentive Program beginning in CY 2014 (77 FR 54049) . We invited and recei ved the following public comments on these proposals:

Comment : Commenters generally supported our pro posal to add a group reporting option for CQMs for the Medicare EHR Incentive Program beginni ng in CY 2014 for EPs who are part of a CPC practice site that successfully submits at least 9 electronically specified CQMs covering 3 domains. Commenters were also pleased that, should a CPC prac tice site fails the requirements established for the CPC Initiative, EPs in the practice site would s till have the opportunity to report CQMs per the requirements established in the EHR Incentive Program Stage 2 final rule for EPs to report under the EHR Incentive Program beginning in CY 2014. These commenters are pleased th at we are proposing to give these EPs another mechanism by which they can meet their reporting requirements under the EHR

### CMS-1600-FC 1131

Incentive Program if they do not meet those require ments vis-à-vis their participation in the CPC

Initiative. Response : We appreciate the commenters’ support for this proposal. In consideration of the comments received and for the reasons stated previ ously, we are finalizing a group reporting option for the Medicare EHR Incentive Program, beginning in CY 2014 that is aligned with the CPC Initiative. Under this option, EPs that successfully report at least 9 electronically specified CQMs covering at least 3 domains for the relevant reporting period as part of a CPC practice site in accordance with the requirements established for the CPC Initiative a nd using CEHRT would satisfy the CQM reporting component of meaningful use for the Medicare EHR Incentive Program. EPs reporting under the aligned group reporting option can only report on CQMs that were selected for the EH R Incentive Program in the Stage 2 final rule. If a CPC practice site is not successful in reporting, EPs who are part of the site would still have the opportunity to report CQMs in accord ance with the requirements established for the EHR Incentive Program in the Stage 2 final rule. Additionally, only those EPs who are beyond their first year of demonstrating meaningful use may use this CPC group reporting option. Please note that the CPC practice sites must submit the CQM data in the form and manner required by the CPC Initiative. Therefore, whether the CPC practice site requires electronic submission or attestation of CQMs, the CPC practice site must submit the CQM data in the fo rm and manner required by the CPC Initiative. 3. Reporting of Electronically Specified Clinical Quality Measures for the Medicare EHR Incentive Program In the EHR Incentive Program Stage 2 final rule , we finalized the CQMs from which EPs would report beginning in CY 2014 unde r the EHR Incentive Program (77 FR 54069, Table 8). These CQMs are electronically specified and updated annually to account for issues such as changes in billing and diagnosis codes. The requirements specified in the EHR Incentive Program Stage 2 final rule for EPs to report under the EHR Incentive Program beginning in CY 2014 allow for the reporting of different versions of the CQMs. However, it is not tec hnically feasible for CMS to accept data that is electronically reported according to the specifications of the older versions of the CQMs, including

### CMS-1600-FC 1132

versions that may be allowed for reporting under the EHR Incentive Program. We stated in the EHR Incentive Program Stage 2 final rule that, consistent w ith section 1848(o)(2)(B)(ii) of the Act, in the event that the Secretary does not have the capacity to r eceive CQM data electronically, EPs may continue to report CQM data through attestation (77 FR 54076). Therefore, we pr oposed that EPs who seek to report CQMs electronically under the Medicare EHR Incentive Program must use the most recent version of the electronic specifications for the CQMs and have CEHR T that is tested and certified to the most recent version of the electronic specifications for the CQMs. For example, for the reporting periods in 2014, EPs who want to report CQM data electronically fo r purposes of satisfying the quality measure reporting component of meaningful use would be required to use the June 2013 version of the CQMs electronic specifications (available at http://www.cms.gov/Regulations-andGuidance/Legislation/EHRIncentiv ePrograms/eCQM_Library.html ) and ensure that their CEHRT has

been tested and certified to the June 2013 versi on of the CQMs for purposes of achieving the CQM component of meaningful use in 2014. EPs who do not wish to report CQMs electronically using the most recent version of the electronic specifications (for example, if their CEHRT has not been certified for that particular version) would be allowed to re port CQM data to CMS by attestation for the Medicare EHR Incentive Program. We invited and received public comments on these proposals:

Comment : Some commenters supported our proposal to a llow EPs to report on older versions of the CQM electronic specifications to CMS by att estation for the Medicare EHR Incentive Program. Response : We appreciate the commenters’ support for this proposal.

Comment : Some commenters recommended that, in lieu of requiring that all EPs report the most recent version of the electronic specifications for the CQ Ms and attest to older versions of the electronic specifications for the CQMs, CMS work with ONC to revise the current development and implementation timeline to ensure one set of measure specifications for all EPs. Response : In the future, we hope to improve our de velopment and implementation timelines so that all EPs would report on only one version of the CQMs. Unfortunately, at this time, it is not

### CMS-1600-FC 1133

technically feasible for CMS to modify our devel opment and implementation timelines to achieve this goal in 2014.

Comment : One commenter opposed our proposal to require EPs who seek to report CQMs electronically under the Medicare EHR Incentive Program to use the most recent version of the electronic specifications for the CQMs and have CEHRT that is t ested and certified to the most recent version of the electronic specifications for the CQMs, as it creates unnecessary burden on EHR vendors. Response : We appreciate the commenter’s response. We respectfully disagree with the commenter’s opposition to require EPs who seek to report CQMs electronically under the Medicare EHR Incentive Program to use the most recent version of the electronic specifications for the CQMs and have

CEHRT that is tested and certified to the most r ecent version of the electronic specifications for the CQMs. We believe it is important for EPs to elect ronically report the most recent versions of the electronic specifications for the CQMs as updated me asure versions correct minor inaccuracies found in prior measure versions. To ensure that CEHRT pr oducts can successfully transmit CQM data using the most recent version of the electronic specifications fo r the CQMs, it is important that the product be tested

and certified to the most recent version of the electr onic specifications for the CQMs. As noted in the proposed rule, at this time, it is not technically feasi ble for CMS to accept more than one version of the electronic measure specifications for the CQMs. For these reasons, except for the measure CMS140v2, Breast Cancer Hormonal Therapy for Stage IC-IIIC Estrogen Receptor/Progesterone Receptor (ER/PR) Positive Breast Cancer (NQF 0387), we are not accepti ng older versions of the electronic specifications for the CQMs.

Comment : The majority of commenters supported our proposal to require EPs who seek to report CQMs electronically under the Medicare EHR Incentive Program to use the most recent version of the electronic specifications for the CQMs and have CEHR T that is tested and certified to the most recent version of the electronic specifications for the CQMs. Some commenters had concerns regarding whether there would be sufficient time for EHR technology developers to update their systems and timely distribute the updated CQM versions in a way that woul d enable EPs to report on the updated versions. A

### CMS-1600-FC 1134

commenter stated that the 6-month release in June for implementation for reporting in the EHR Incentive Program beginning in January 1, 2014 may not provide enough time for CEHRT systems to be updated. Therefore, the commenter requested that any updates made to measure specifications be minimal. Any major changes to the measure itself, the measure logic, or the value sets would require additional time to address all necessary steps in the implementa tion process, and should be avoided. Response : We understand the commenter’s concerns re garding the implementation timeline. We agree that any changes to the electronic specifications for the CQMs should be non-substantive. Indeed, please note that, as we noted in the EHR Incentive Progr am Stage 2 final rule, any substantive changes that will be made to the CQM electronic measure specifications will be non- substantive (77 FR 54055- 54056). Therefore, after consideration of the comments re ceived and for the reasons stated previously, we are finalizing the following proposal: EPs who seek to report CQMs electronically under the Medicare EHR Incentive Program must use the most recent vers ion of the electronic specifications for the CQMs

and have CEHRT that is tested and certified to the most recent version of the electronic specifications for the CQMs. We are also finalizing the policy that EPs who do not wish to report CQMs electronically using the most recent version of the electronic specifica tions (for example, if their CEHRT has not been certified for that particular version) will be allowe d to report CQM data to CMS by attestation for the Medicare EHR Incentive Program. For further explanati on of reporting CQMs by attestation, we refer readers to the EHR Incentive Program Stage 1 final rule (77 FR 44430 through 44434) and the EHR Incentive Program’s Registration and Attestation page (available at https://ehrincentives.cms.gov/hitech/login.action ). Please note that for attestation we are not requiring that products reporting on older versions of the elect ronic specifications for the CQMs have CEHRT that

is tested and certified to the most recent version of the electronic specifications for the CQMs. Rather, if attesting to older versions of the electronic specificat ions for the CQMs, it is sufficient that the product is

CEHRT certified to the 2014 Edition certification criteria.

### CMS-1600-FC 1135

For the reporting periods in 2014, EPs who want to report CQM data electronically (through a qualified clinical data registry or other product that is CEHRT) to satisfy the quality measure reporting component of meaningful use must use the June 2013 version of the CQMs electronic specifications (available at http://www.cms.gov/Regulations-andGuidance/Legislation/EHRIncentiv ePrograms/eCQM_Library.html ). CQM data must be submitted using either the QRDA-I or QRDA-III format as finalized in th e Stage 2 final rule (77 FR 54076). In addition,

EPs must ensure that their CEHRT has been tested a nd certified to the June 2013 version of the CQMs for purposes of achieving the CQM component of meaningful use in 2014. Please note that, for 2014 only, we are providing one exception to this rule for th e measure CMS140v2, Breast Cancer Hormonal Therapy for Stage IC-IIIC Estrogen Receptor/Progesterone Re ceptor (ER/PR) Positive Breast Cancer (NQF 0387) because an error was found in the June 2013 logic of this measure. The June 2013 version of this measure was posted on CMS’s website on June 29, 2013. The error relates to the relative timing of the diagnosis of breast cancer and the diagnosis of ER or PR positive breast cancer. In clinical practice, a diagnosis of breast cancer should precede the more speci fic diagnosis of ER or PR positive breast cancer. The logic in CMS140v2 reverses this order. The expected impact of this error is that very few but most likely no patients will meet the denominator criteria. Therefore, if EPs want to report this measure electronically, we are requiring that EPs report on the measure CMS140v1, which is the prior, December 2012 version of the measure CMS140v2, Breast Canc er Hormonal Therapy for Stage IC-IIIC Estrogen Receptor/Progesterone Receptor (ER/PR ) Positive Breast Cancer (NQF 0387). To the extent that an EP reports another version of this measure other th an CMS140v1, (for example, if their certified EHR technology includes the other version), we require EPs to report the other version by attestation. Should an EP report on CMS140v2, the June 2013 version of the measure titled Breast Cancer Hormonal Therapy for Stage IC-IIIC Estrogen Receptor/Prog esterone Receptor (ER/PR) Positive Breast Cancer (NQF 0387), the EP must report this June 2013 version of the measure by attestation. 4. Reporting Periods in CY 2014

### CMS-1600-FC 1136

In the Stage 2 final rule, we established the EHR reporting periods in CY 2014 for EPs that have previously demonstrated meaningful use (77 FR 5 3975). Specifically, we finalized a three-month CY quarter EHR reporting period for 2014, which mean s that Medicare EPs will attest using an EHR reporting period of January 1, 2014 through March 31, 2014; April 1, 2014 through June 30, 2014; July 1, 2014 through September 30, 2014; or October 1, 2 014 through December 31, 2014. We also established the reporting periods for CQMs in CY 2014, which are generally the same as the EHR reporting period (77 FR 54049-54051). Although we did not propose to change these established reporting periods, we understand that there may be instances where an EP may prefer to report CQM data for a certain quarter and report the meaningful use objectives and measures for a different quarter. For example, a technical problem could arise for a submission of CQM data that would not affect an EP’s submission of meaningful use functional measures, or vice versa. To provide additional flexibility for EPs, we will accept reporting periods of different quarters for CQMs and for meaningful use functional measures, as long as the quarters are within CY 2014. We note that if an EP chooses to use a reporting option for the Medicare EHR Incentive Program that aligns with another CMS quality reporting program, the EP should be mindful of the reporting period required by that program if the EP seeks to meet the quality measure reporting requirements for both the Medicare EHR In centive Program and the aligned quality reporting

program.

### CMS-1600-FC 1137

J. Medicare Shared Savings Program Under section 1899 of the Act, CMS has established the Medicare Shared Savings Program (Shared Savings Program) to fac ilitate coordination and cooperation among providers to improve the quality of care for Medicare Fee-For-Service (FFS) be neficiaries and reduce the rate of growth in healthcare costs. Eligible groups of providers and suppliers, including physic ians, hospitals, and other healthcare providers, may participate in the Shared Sa vings Program by forming or participating in an Accountable Care Organization (ACO). The fina l rule implementing the Shared Savings Program appeared in the November 2, 2011 Federal Register (Medicare Shared Savings Program: Accountable Care Organizations Final Rule (76 FR 67802)). ACOs are required to completely and accurate ly report on all quality performance measures for all quality measurement reporting periods in each perform ance year of their agreement period. There are currently 33 quality performance measures under the Sh ared Savings Program. For Shared Savings Program ACOs beginning their agreement period in April or July, 2012, there will be two reporting periods in the first performance year, correspondi ng to calendar years 2012 and 2013. For ACOs beginning their agreement periods in 2013 or later, both the performance year and reporting period will correspond to the calendar year. Reporting on measures associated with a reporting period will generally be done in the spring of the following calendar year. For example, an ACO w ill submit quality measures for the 2015 reporting period in early 2016. 1. Medicare Shared Savings Program and Physicia n Quality Reporting System Payment Adjustment Section 1899(b)(3)(D) of the Act affords the Secr etary discretion to “* * * incorporate reporting requirements and incentive payments related to th e physician quality repor ting initiative (PQRI), under section 1848, including such requirements and such paym ents related to electronic prescribing, electronic health records, and other similar initiatives under sect ion 1848 * * *” and permits the Secretary to “use

alternative criteria than would ot herwise apply [under section 1848 of the Act] for determining whether to make such payments.” Under this authority, we inco rporated certain Physician Quality Reporting System (PQRS) reporting requirements and incentive payments into the Shared Savings Program, including: (1)

### CMS-1600-FC 1138

the 22 GPRO quality measures identified in Table 1 of the final rule (76 FR 67889 through 67890); (2) reporting via the GPRO web interface; (3) criteria for satisfactory reporting; and (4) set January 1 through December 31 as the reporting period. The regulation governing the incorporation of PQRS incentives and reporting requirements under the Shared Savi ngs Program is set forth at §425.504. Under section 1848(a)(8) of the Act, a payment adjustment will apply under the PQRS beginning in 2015 based on quality reporting during the applicab le reporting period. Eligible professionals who do not satisfactorily report quality data in 2013 will be s ubject to a downward payment adjustment applied to the PFS amount for covered professional services furnis hed by the eligible professional during 2015. For eligible professionals subject to the 2015 PQRSpaym ent adjustment, the fee schedule amount is equal to 98.5 percent (and 98 percent for 2016 and each subseque nt year) of the fee schedule amount that would otherwise apply to such services. To continue to align Shared Savings Program requirements with PQRS, for the 2013 reporting period (which will be used to determine the 2015 PQRS payment adjustment to PFS amounts), in the CY 2013 PFS final rule with comment (77 FR 69372), we amended §425.504 to include the PQRS reporting requirements necessary for eligible professionals in an ACO to avoid the 2015 PQRS payment adjustment. Specifically, we requi red ACOs on behalf of eligible professionals that are ACO providers/suppliers to successfully repor t one ACO GPRO measure in 2013 to avoid the payment adjustment in 2015. We also provided that ACO providers/suppliers that are eligible professionals may only participate under their ACO pa rticipant tax identification number (TIN) as a group practice for purposes of avoiding the PQRS payment ad justment in 2015. Thus , ACO providers/suppliers who are eligible professionals may not seek to a void the payment adjustment by reporting either as individuals under the traditional PQRS or under th e traditional PQRS GPRO under their ACO participant TIN. We note, however, that eligible professiona ls may bill Medicare under more than one TIN (for example, eligible professionals may bill Medicar e under a non-ACO participant TIN in one practice

location and also bill Medicare under the TIN of an AC O participant at another practice location). As a result, ACO providers/suppliers who are eligible pr ofessionals that bill under a non-ACO participant TIN during the year could and should participate under th e traditional PQRS as either individual EPs or a

### CMS-1600-FC 1139

group practice for purposes of avoiding the PQRS pa yment adjustment for the claims billed under the non-ACO participant TIN. In fact, such EPs would have to do so to avoid the PQRS payment adjustment with respect to those claims because the regulation at §425.504 only applies to claims submitted by ACO providers/suppliers that are eligib le professionals billing under an AC O participant TIN. If eligible professionals within an ACO meet the requirement s for avoiding the PQRS payment adjustment established under the Shared Savings Program, only th e claims billed throu gh the TIN of the ACO participant will avoid the payment adjustment in 2015. 

### For the 2014 reporting period and subsequent reporting periods (whi ch would apply to the PQRS payment adjustment for 2016 and subse quent payment years), we proposed to align with the requirements for reporting under th e traditional PQRS GPRO through the CMS web interface by amending §425.504 to requi re that ACOs on behalf of their ACO providers/suppliers who are eligible professionals satisfactorily report the 22 ACO GPRO measures during the 2014 and subsequent reporting periods to avoi d the PQRS payment adjustment for 2016 and subsequent payment years (78 FR 43482). Additi onally, we proposed to continue the current requirement that ACO providers/suppliers who ar e eligible professionals may only participate under their ACO participant TIN for purposes of the payment adjustment in 2016 and subsequent

years. As we stated in the proposed rule (78 FR 43482), we believe th at the proposal to modify the requirements for ACOs to satisfactorily report the 22 ACO GPRO measures to avoid the 2016 payment adjustments would not increase burden on ACOs or on ACO providers/suppliers that are eligible professionals because ACOs must already report these measures in order to satisfy the Shared Savings Program quality perfor mance standard. Thus, this proposal would not

increase the total number of measures that must be reported by the ACO and its ACO providers/suppliers that are elig ible professionals. We also not ed that these proposals would not

### CMS-1600-FC 1140

affect the Shared Savings Program quality pe rformance standard repo rting requirement under which ACOs are currently required to repor t on 33 quality performance measures, which includes all 22 of the ACO GPRO quality measures.

Comment : We received several comments in favor of continued alignment with PQRS reporting requirements and ongoing efforts to harmonize the program. We received no comments against continued alignment. On e commenter said alignment minimizes the additional reporting burden on ACOs and is consistent with ongoi ng quality initiatives. Another commenter said alignment between programs eas es administrative burden. In addition we

received some comments about th e Pioneer ACO Model’s alignment with PQRS that are out of the scope of this proposed rule. We have sh ared these comments with our colleagues in the Innovation Center. In addition, tw o commenters stated that when a physician leaves an ACO, the ACO should not be responsible for repor ting quality measures for that physician. Response : We appreciate the comments in support of our proposal, and for the reasons discussed above and in the proposed rule, we are finalizing our proposal to align with PQRS GPRO web interface reporting requirements, finalized elsewhere in this PFS, for eligible professionals (EPs) and their participant TINs in ACOs to avoid the payment adjust ment in 2016 and subsequent years. We are also finalizing our proposal to add a new paragraph (c) to the regulation at §425.504 to reflect these reporting requirements for 2016 and subsequent years. Although we are finalizing this policy as proposed, we have

made some technical corrections to the text and form atting of §425.504(c) in order to remove inconsistent language that was inadvertently included in this prov ision as it appeared in the proposed rule. With respect to the comments about changes in the ACO participants and ACO pr oviders/suppliers and the effect on ACO quality reporting, these issues are are out of the scope of this rule. We note, however, that we have addressed the effect of changes in ACO pa rticipants on ACO quality reporting in subregulatory guidance available at http://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/sharedsavingsprogram/Updati ng-ACO-Participant-List.html. Additionally, ACOs are required

### CMS-1600-FC 1141

to report certain measures using the GPRO web inte rface tool. Specifically, §425.504(a)(1) and (b)(1) require that ACOs submit quality measures using the GPRO web interface to qualify on behalf of their eligible professionals for the PQRS incentive or to avoid the PQRS payment adjustment. This reporting mechanism is also referenced in §425.308(e), whic h provides that quality measures that ACOs report using the GPRO web interface will be reported by CMS on the Physician Compare website. 

### Under §414.90(h)(3)(i), group prac tices may report data under the traditional PQRS GPRO through a CMS web interface. The Shared Savings Program regulations at §425.504(a)(1) and (b)(1) and §425.308(e) specifically reference the use of the GPRO web interface for quality reporting purposes. We pr oposed to amend these regulations to replace

references to GPRO web interface with CMS web in terface. We believe this change will ensure consistency with the reporting mechanism used under §414.90(h)(3)(i) and will also allow for the flexibility to use a similar web interface in the event that operati onal issues are encountered with

the use of the GPRO web interface. We invited public comment on this proposal.

Comment : We did not receive direct comments against broadening our reference to the web interface; however, one commenter expresse d concern that the sugg ested change signaled that CMS intends to change the reporting mech anism and the commenter opposed any change in reporting mechanism saying, it took time and resources to learn the current reporting mechanism. Response : We are finalizing our proposal to use the more broad term CMS web interface to align with PQRS, and are also finalizing the proposed revi sions to our regulations at §§ 425.308(e) and 425.504(a)(1) and (b)(1) to reflect this change. We would like to reassure Shared Saving Program ACOs that we do not currently have plans to change th e reporting mechanism for Shared Savings Program ACOs from the GPRO web interface. However, broade ning the term to “CMS web interface” aligns with PQRS and gives CMS the flexibility to use an a lternative web interface in the event that PQRS requirements change or operational issues with th e GPRO web interface adversely impact ACO quality reporting.

### CMS-1600-FC 1142

We also received a comment making suggestions about the reporting mechanism used under the

Pioneer ACO Model. This comment is out of the sc ope of the proposed rule, but we have shared the comment with our colleagues in the Innovation Center. 2. Medicare Shared Savings Program-Establis hing the Quality Performance Benchmark Section 1899(b)(3)(C) of the Act directs the S ecretary to “* * *establish quality performance standards to assess the quality of care furnished by ACOs * * *” and to “improve the quality of care furnished by ACOs over time by specifying higher standards, new measures, or both for purposes of assessing such quality of care.” In the Shared Savi ngs Program final rule, we finalized the following requirements with regard to establishing a performan ce benchmark for measures: (1) During the first performance year for an ACO, the quality performance standard is set at the level of complete and accurate reporting; (2) during subse quent performance years, the quality performance standard will be phased in such that ACOs will be assessed on th eir performance on each measure; (3) CMS designates a performance benchmark and minimum attainment level for each measure, and establishes a point scale for the measures; and (4) contingent upon data availa bility, performance benchmarks are defined by CMS based on national Medicare fee-for-service rates, national Medicare Advantage (MA) quality measure rates, or a national flat percentage. In the final ru le, we indicated that we would not compare an ACO’s quality performance to the performance of other AC Os for purposes of determining an ACO’s overall quality score. We acknowledged, however, that in futu re program years, we should seek to incorporate actual ACO performance on quality measures into the quality benchmarks after seeking industry input through rulemaking.

a. Data Sources Used to Establish Performance Benchmarks The regulation governing the data that CMS will use to establish the performance benchmarks for quality performance measures under the Shared Savings Program is set forth at §425.502(b)(2). This provision states that CMS will define the performan ce benchmarks based on national Medicare fee-forservice rates, national MA quality measure rates, or a national flat percentage. In the Shared Savings Program final rule, we responded to comments sugges ting that quality performance benchmarks be set

### CMS-1600-FC 1143

based on actual historical data submitted by ACOs. We stated that although we agreed that we should seek to incorporate actual ACO performance on quality scores into the quality benchmark, we would do so only in future rulemaking so that we could seek industry input. In a ddition, we noted that we expected to update the quality benchmarks over time, consistent with section 1899(b)(3)(C) of the Act, which requires CMS to seek to improve the quality of care furnished by ACOs participating in the Shared Savings Program over time.

Consistent with our stated intention to inco rporate actual ACO experience into quality measure benchmarks, for the 2014 reporting period, we propo sed to amend §425.502(b)(2) to permit CMS to use all available and applicable national Medicare Adva ntage and Medicare FFS performance data to set the quality performance benchmarks. Specifically, in addition to using available national Medicare FFS rates, which include data reported through PQRS, an d national MA quality measure rates, we proposed to use data submitted by Shared Savings Program and Pioneer ACOs in 2013 for the 2012 reporting period to set the performance benchmarks for the 2014 report ing period. We proposed to publish the quality benchmarks based upon these data prior to the beginning of the 2014 reporting period through subregulatory guidance. As stated in the Shared Savings Program final rule, we establish benchmarks using the most currently available data source and the most recent available year of benchmark data prior to the start of the reporting period. In other words, data collected in 2014 from the 2013 reporting period would be used in conjunction with other available data to set benchm arks for the 2015 reporting period, and so on. We proposed to retain the option of using flat percentages when data are unavailable, inadequate or unreliable to set quality performance be nchmarks. Further, we clarified our intent to

combine data derived from national Medicare Advant age and national Medicare FFS to set performance benchmarks when the measure specifications used under Medicare Advantage and FFS Medicare are the same. We proposed to revise §425.502(b)(2)(i) to refl ect this clarification. We solicited comment on these proposals, and whether there are other data sour ces that should be considered in setting performance

benchmarks.

### CMS-1600-FC 1144

Comment : We received a generally favorable respon se to incorporating ACO data into setting the benchmarks, and a few commenters supported usin g all available data, including ACO data, to establish benchmarks; one commenter in favor of using all data stated 

### more data are better for setting benchmarks, and including ACO data emphasizes th at CMS expects all providers to improve quality

. However, most commenters opposed the proposal to use ACO data alone when no other data were available to set benchmarks, stating that they believe d that when only ACO data were available it would unfairly narrow the data set. They stated that ACOs should be assessed against the broader FFS population instead of only against themselves. A few commenters stated that culture and the socioeconomic status of some patient populations coul d adversely affect scoring for these organizations if they were compared only to other ACOs, particular ly on the CAHPS measures, and that each community

and its resources and characteristics should be taken into account when establishing benchmarks, including rewarding ACOs on the basis of individual improvement. Similarly, other commenters felt that using ACO data alone would inflate the benchmarks and make them unattainable to new ACOs entering into the program the following year. A few commenters suggested that CMS not move to pay for performance, but rather continue pay for reporting wh en there are only ACO data available to set the benchmark. One commenter stated “Among [Pioneer ] ACOs, some metrics had a wide variation of interpretation that resulted in a bimodal distribution. When there is such a bimodal distribution, separate benchmarks should be used based on [ACO] interpreta tion [of the measure] – higher benchmarks for wide interpretation, lower benchmarks for stricter inte rpretation.... We recommend that benchmarks be based only on the subset of data consistent with the [ACO ] interpretation that was chosen.” When data other than ACO data are available, many commenters were opposed to combining it with MA data, stating that the structure of the MA program, with closed networks and the opt-in of beneficiaries, enables MA plans to attain higher performance scores. Some commenters also stated it was not fair to include PQRS GPRO data in developing quality pe rformance benchmarks for ACOs because groups reporting under the PQRS GPRO are more advanced or integrated organizations that have multiple years of experience in collecting and reporting medical record data.

### CMS-1600-FC 1145

On the other hand, regarding use of flat percenta ges, one of the commenters said flat percentages should never be used. Another commenter suggested th at flat percentages should only be used if the 60 th percentile had a value of 70 percent or greater, particul arly in relation to measures that are clustered. A commenter suggested starting with a flat percentage that is lower than actual ACO data, and then increasing the benchmark as more data become available in order to measure and reward ACO improvement over time. Regarding our proposal to set benchmarks yearly based on the previous year’s ACO reporting, a commenter expressed concern about fluctuating benchmar ks in the event that CMS finalized its proposal to set benchmarks yearly based on the previous y ear’s ACO data submission. Commenters noted that such a policy may unfairly disadvantage ACOs joining the program, particularly when only ACO data are

available to set benchmarks. Response : We are finalizing our proposal to use fee-for-service data, including data submitted by Shared Savings Program and Pioneer ACOs to set the performance benchmarks for the 2014 and subsequent reporting periods. Alt hough we continue to believe it is appropriate to combine data from MA and PQRS reporting when the quality measure specifi cations are the same, or to use MA data when FFS data are unavailable, we are swayed by commente rs who request that in light of the different structure of the MA program, we reconsider using MA data to set benchmarks in the early stages of the program. Therefore, we will not finalize our proposal to use MA data alone or in combination with feefor-service data in the short-term. We intend to revi sit the policy of using MA data in future rulemaking when we have more experience se tting benchmarks for ACOs. Howeve r, we are finalizing our proposal to combine all available Medicare fee-for-service qua lity data, including data gathered under PQRS (through both the GPRO tool and other quality reporting mechanisms). We continue to believe that it is appropriate to use PQRS GPRO data to set benchmarks because the measure specifications are the same and are submitted by FFS providers. We do not ag ree with commenters who suggested that PQRS GPROs have an unfair advantage over other pr oviders because PQRS GPROs range in size and capability. Nor do we agree with commenters that recommended setting benchmarks that take into

### CMS-1600-FC 1146

consideration ACO interpretation of measure speci fications. The GPRO web interface and measure specifications, as well as education on how to report th e measures, are equally available to all Medicare enrolled providers, and the measure specifica tions are not subject to ACO interpretation. 

### Finally, we recognize the concer ns raised by commenters that setting benchmarks based on ACO data alone, particularly in the early years of the Shared Savings Program, could result in punishing relatively high performers for qua lity measures where performance is high among most ACOs. Additionally, we a ppreciate the suggestions by comm enters who incorporated our proposed de-clustering methodology on when and how to use flat percentages to reward high performance. We are finalizing an approach that makes use of a combination of actual data and flat percentages; specifically, we will use al l available FFS data to calculate benchmarks, including ACO data, except where performance at the 60 th 

### percentile is equal to or greater than 80 percent for individual measures, regardless of whether or not the measure is clustered. In these cases, a flat percentage will be used to set the benchmark for the measure. By way of example, please refer to Table 81. This policy al lows ACOs with high scores to earn maximum or near maximum quality points while allowing room for improvement and rewarding that improvement in subsequent years. We chose 80 percent because this level of attainment indicates a high level of performance and we be lieve ACOs achieving an 80 percent performance rate should not be penali zed as low performers.

### CMS-1600-FC 1147

TABLE 81: Methodology for setting benchmarks using flat percentages Percentile 30 th 40 th 50 th 60 th 70 th 80 th 90 th Performance rates using all available FFS data 85.83 86.21 86.76 87.15 87.65 88.21 89.23 Revised benchmark using flat percentages when the 60 th percentile is 80 percent or

more. 30.00 40.00 50.00 60.00 70.00 80.00 90.00

Quality points earned by the ACO** 1.10 1.25 1.40 1.55 1.70 1.85 2.0

Example is for illustration purposes only and is not based on actual data **Note: points are double the points shown here for the EHR measure.



### We are also finalizing our proposal to set be nchmarks prior to th e reporting year for which they would apply. Specifically, we ar e finalizing our proposal to set the quality performance benchmarks for the 2014 reporting period using data submitted in 2013 for the 2012 reporting period. We will publish the quality performance benchmarks for the 2014 reporting period through subregulatory guid ance. However, we are not fi nalizing our proposal to modify the benchmarks on a yearly basis. We recogni ze commenters’ concerns that for some measures in the first few years, we will only have a li mited amount of data which may cause benchmarks to fluctuate in early program years, making it difficult for ACOs to improve upon their previous year’s performance. Instead, we will set the benchmarks for the 2014 reporting year in advance using data submitted in 2013 for the 2012 reporting y ear, and continue to use those benchmarks for 2 reporting years (specifica lly, the 2014 and 2015 reporting years) . We intend to readdress this issue in future rulemaking to allow for public comment on the appropriate number of years before updating benchmarks going forward. We ha ve revised the regula tion at §425.502(b)(2) to reflect these final policies with respec t to defining the quality benchmarks. b. Ensuring Meaningful Differences in Performance Rates Data collected by CMS from the GPRO and Phys ician Group Practice Demonstration participants in 2012 coupled with previous CMS experience indica tes that using actual data to calculate quality

### CMS-1600-FC 1148

performance may result in some measures’ performance rate s being tightly clustered. In this case, quality scores for the measure may not reflect clinically meaningful differences between the performance rates achieved by reporters of quality. For example, for some measures, the distribution of performance rates may have a spread of less than 2.0 percentage points between the 30 th and 90 th percentiles. In such an instance, even though there is little distinction in actual performance rates, a slight difference in performance on the measure may result in a significant difference in the number of quality points obtained under the Shared Savings Program. For example, two separate ACOs at the 50 th percentile and

the 90 th percentile may have only a few tenths of a percentage point difference in their actual performance, but under the Shared Savings Program scoring methodology, the difference between their quality scores for that measure would be more notew orthy (1.4 points versus 2.0 points).

We continue to believe it is desirable to use performance rates for measures based on actual data because doing this creates benchmarks that are simple to understand and apply, even if the rates are clustered, as the data reflect achievable performance on quality measures. However, allowing clustered performance rates for a measure may result in payment differences that are not associated with clinically meaningful differences in patient care, as noted in the example above. Keeping these issues in mind, we proposed to develop a methodology to spread clustered performance on measures. The first step in developing that methodology is to identify when performance on a measure is clustered. Clustering could be defi ned as less than a certain spread between performance rates in an identified range; for example, less than 6.0 percentage points between the performance rates

associated with the 30 th and 90 th percentiles, or less than 10.0 percentage points between the minimum and maximum values achieved by prev ious reporters of the quality meas ure. Alternatively, clustering could be defined as a spread of performance rates of less than x percentage points between any two deciles, for example, less than a 1.0 percentage point difference between the 60 th and 70 th decile. Once a clustered measure has been identified, the ne xt step is to apply a methodology to spread or separate the performance rates within the measure. It is important to establish a meaningful performance rate, or starting point, around which to differentiate or spread the performance. For example, selecting a

### CMS-1600-FC 1149

certain percentile or median value may represent one option for establishing a reasonable starting point. Once the starting point is set, then we could implem ent a series of fixed percentage point intervals around the starting point in both a positive and negative direc tion to increase the spread, for example, applying a fixed 1.0 percentage point interval between scored deciles. For example, if the starting point is the 60 th percentile, and the performance rates at the 60 th and 70 th percentiles were observed to be 77.15 and 77.65 respectively, there would be only a 0.5 spread betwee n the deciles. In contrast, applying a fixed 1.0 percentage point interval to increase spread would r esult in a 1.0 difference between these rates, and the new performance rates would be 77.15 and 78.15 at the 60 th and 70 th percentiles, respectively. In the alternative, we could take the spread calculated fro m a subset (for example, ACO performance only) of the underlying performance data if we believe that data reported by ACOs s how a different variability than other data sources. For example, the spread between the measure’s percentiles could be based on historical ACO distribution only, not the historical distribution of Medicare Advantage and/or national fee-for-service, PQRS, and ACO data. The historical ACO distribution could then be applied to the Medicare Advantage and/or national fee-for-service, PQRS, and ACO percentile distribution to establish the measure’s percentiles. In the proposed rule, we stated that we believe that a clinically meaningful assessment of ACO quality is important. We also noted that we are in terested in providing a pathway for ACOs new to quality reporting to achieve the quality reporting stan dard, and an incentive for experienced ACOs to continue improving and performing at high levels. We therefore proposed to use a standardized method for calculating benchmark rates when a measure’s perfo rmance rates are tightly clustered. We proposed that the application of a methodology to reduce meas ure clustering would only apply to quality measures whose performance rates are calculated as percentiles, that is, the methodology would not apply to measures whose performance rates are calculated as ra tios, for example, measures such as the two ACO Ambulatory Sensitive Conditions Admissions and the All Condition Readmission measure. We believe that measures whose performance rates are calculate d as ratios already demonstrate a high degree of

### CMS-1600-FC 1150

clinically meaningful differences because they are risk adjusted to reflect the health status of the patient population being measured. We proposed to define a tightly clustered me asure, including clinical process and outcome measures reported through the GPRO web interface a nd CAHPS measures, as one that demonstrates less than a 6.0 percentage point spread in performance rates between the 30 th and 90 th percentiles. As discussed in the proposed rule, we believe using the 30 th and 90 th percentiles as the lower and upper

bounds is reasonable because these bounds have been given some significance in earlier rulemaking; specifically, the Shared Savings Program regulations set the ACO’s minimum attainment level at the 30 th percentile, below which the ACO achieves no point s, and the ACO achieves full points for quality reporting at or above the 90 th percentile. Further, we proposed to establish the starting point at the 60 th percentile, the midpoint between the 30 th and 90 th percentiles, and then to apply a positive 1.0 fixed percentage point interval for each decile above the 60 th percentile and a negative 1.0 fixed percentage point interval for each decile below the 60 th percentile. We recognized that spreading tightly cluste red performance measures would decrease the lower bound necessary to meet the minimum attainment leve l for the measure, giving ACOs new to quality reporting a greater opportunity to meet the quality perf ormance standard. At th e same time, spreading tightly clustered performance rates would increase the upper bound necessary for achieving the maximum available quality points for the measure, giving alr eady experienced ACOs an incentive to continue improving quality. Applying a 1.0 fixed percentage point interval achieves the goal of creating meaningful differences in performance . Further, we stated that we believe that applying a 1.0 fixed percentage point interval represents a tempered and reasonable interval that does not spread performance rates to levels that are too easy to achieve on th e lower bound or too difficult to achieve on the upper

bound. For example, Table 82 demonstrates the original spread of a quality measure, based on all available data, which is compressed from a range of 75.83 at the 30 th percentile to 79.23 at the 90 th percentile, that is, a spread of less than 6.0 per centage points. When the proposed methodology is

### CMS-1600-FC 1151

applied, the 60 th percentile (or 77.15 percent), serving as th e starting point, remains unchanged. The spread increases 6.0 percentage points from 74.15 at the 30 th percentile to 80.15 at the 90 th percentile. As demonstrated and explained above , this methodology improves the distinction in performance between the minimum attainment level (30 th percentile) and the maximum attainment level (90 th percentile). TABLE 82: Proposed Methodology to Reduce Clustered Performance Rates Percentile 30 th 40 th 50 th 60 th 70 th 80 th 90 th Original performance rates using all available data 75.83 76.21 76.76 77.15 77.65 78.21 79.23 Performance rates using methodology to reduce clustering 74.15 75.15 76.15 77.15 78.15 79.15 80.15

*Example is for illustration purpos es only and is not based on actual data We proposed to amend §425.502(b) to reflect this methodology to reduce clustering. We solicited comment on these proposals. Specifically, we sought comment on whether or not a methodology should be applied to spread out clus tered performance on measures. We also solicited comment on the proposal to define clustered perform ance on a measure as one in which the spread of performance rates between the 30 th and 90 th percentiles is less than 6.0 percentage points, or whether other

values should be used to define clustered measure performance, for example, when the minimum and maximum reported values are spread by less than 10.0 percentage points. We also solicited comment on whether there are alternative methodologies that should be considered to spread out clustered performance on measures. In addition, we solicited comment on whether measures that are calculated as ratios should be excluded from this methodology. We also requested comment on whether all available

relevant data should be considered when developing the spread between measures, or whether only the relevant performance data from a subset of reporte rs, such as ACO-reported data, as discussed above, should be used to determine the appr opriate spread between deciles.

Comment : We received many comments against creating a larger spread when quality measure

benchmarks are clustered. No commenters were in favor of spreading benchmarks when they are clustered. Alternatives proposed by commenters were to continue pay for reporting when the scores are clustered, or to develop a methodology that rewa rds improvement in individual ACO quality scores and to structure points to reward “positive outliers” wh en scores are clustered at the lower scores. A

### CMS-1600-FC 1152

commenter said, “While there may not be a signifi cant spread for comparison, those entities that do perform at a relatively close level of quality perform ance should be recognized for their actual level of performance.” A commenter suggested considering approaches that are not threshold- and benchmarkbased, but instead reward every single instance wh en correct care was provided. Another commenter suggested using fewer points of differentiation such as quartile scores rather than decile scores for clustered measures. A commenter suggested CMS adopt a methodology that rewards all the good performing programs and further rewards the excellent “best practices.” A commenter suggested using a flat percentage if the 60 th percentile value is above an absolute ra te of 70 percent as an alternate approach to addressing tightly clustered measures. 

### Response : We appreciate the comments and sugg estions for alternatives for addressing tightly clustered measures. We are not finali zing the proposal to create a spread when benchmarks are tightly clustered. We are conv inced by commenters who said that spreading

benchmarks could create artificial clinically meaningful differe nces in quality reporting and payment, particularly when underlying performan ce relative to peers would remain unchanged. However, we reserve the right to revisit this issue in future rulemaki ng when we have more experience and data. Instead, we will use the method described abov e which will take into account actual ACO performance on measures by using FFS data (i ncluding ACO and PQRS reported data) where

available to set benchmarks ex cept where performance at the 60 th 

### percentile is e qual to or greater than 80 percent, in which case, flat percentages w ill be used to set the benchmark. We chose this threshold for the reasons noted above. This method will both reduce clustering for these measures and reward ACOs for actual performance. Additionally, as we move toward using ACO data to set benchmarks, we will continue to consider how clustering of measures intersects with our ability to determine both an appropriate minimum sta ndard for a quality measure as

### CMS-1600-FC 1153

well as how the overall performance on that measur e is scored for the ACO, or whether these concepts should be decoupled. Finally, in response to comments on alternativ e explicit ways to reward improvement, we note that the Shared Savings Pr ogram methodology rewards organiza tions with a greater share of savings for higher quality performa nce in pay for performance year s; however, we will continue to consider this issue and may addr ess it further in future rulemaking. c. Scoring CAHPS Measures Within the Patient Experience of Care Domain The preamble to the Shared Savings Program fi nal rule (76 FR 67895-67900) outlines the total potential points available per domain as demonstrated in Table 83. As indicated in Table 83, under the final rule the Patient/Caregiver Experience Domain is weighted equally with the other three quality domains at 25 percent and consists of 2 measures: a composite of six Clinician and Group (CG) CAHPS summary survey measures (1) Getting Timely Care, Appointments and Information, (2) How Well Your Doctors Communicate, (3) Patient’s Rating of Doctor, (4) Access to Specialists, (5) Health Promotion and Education, (6) Shared Decision Making, and a H ealth Status/Functional Status measure. The six measures included in the composite will transition to pay-for-performance starting in the second year of an ACO’s agreement period. In contrast, the Hea lth Status/Functional Status measure will remain payfor-reporting throughout the ACO’s entire agreement period.

TABLE 83: Total Points for Each Domain within the Quality Performance Standard

Domain Total Individual Measures (Table F1) Total Measures for Scoring Purposes Total Potential Points Per Domain Domain Weight

Patient/Caregiver Experience 7 1 measure, with 6 survey module measures combined, plus 1 individual measure 4 25% Care Coordination/ Patient Safety 6 6 measures, plus the EHR measure doubleweighted (4 points) 14 25% Preventative Health 8 8 measures 16 25% At Risk Population 12 7 measures, including 5 component diabetes composite measure and 2 component CAD composite measure 14 25%

### CMS-1600-FC 1154

Domain Total Individual Measures (Table F1) Total Measures for Scoring Purposes Total Potential Points Per Domain Domain Weight

Total 33 23 48 100% *from Table 4 in the Shared Savings Program Final Rule (76 FR 67899)

The result of this point system is that performa nce on the six patient experience measures is worth only 12.5 percent of an ACO’s total performance score because the other 12.5 percent of the Patient/Caregiver Experience domain is the Health St atus/Functional Status measure, which is a pay-forreporting measure for all performance years. However, as we stated in the proposed rule, we believe that each of these seven measures is equally important wi thin the Patient/Caregiver Experience domain, and that scoring within the domain should better refl ect performance on these measures, thereby placing a greater emphasis on the voice of the patient thro ugh patient-reported outcomes and experiences. We believe that increasing the weight of the 6 measure s that will become pay-for-performance in the second year of the agreement period will incentivize ACOs to improve their performance on these measures. A policy to place a greater emphasis on patient-reported outcomes and experiences is consistent with our goal to improve the quality of care furnished by ACOs over time. Therefore, we proposed to modify the point sco ring for the Patient/Caregiver Experience domain as demonstrated in Table 84. As modified, each of the 7 survey module measures within the domain would be assigned a maximum value of 2 points. Th e Patient/Caregiver Experience domain would then be worth a total of 14 points, rather than 4 points. The end result would be that each of the 7 measure modules in the domain would have equal weight. We noted that this change would not affect the

### CMS-1600-FC 1155

weighting of the domain itself in relationship to the other three domains; it would remain 25 percent of the ACO’s total quality performance score.

TABLE 84: Modified Total Points for Each Do main within the Quality Performance Standard

Domain Total Individual Measures (Table F1) Total Measures for Scoring Purposes Total Potential

Points Per Domain Domain Weight Patient/Caregiver Experience 7 7 individual survey module measures 14 25% Care Coordination/ Patient Safety 6 6 measures, plus the EHR measure double-weighted (4 points) 14 25% Preventative Health 8 8 measures 16 25%

At Risk Population 12 7 measures, including 5 component diabetes composite measure and 2 component CAD composite measure 14 25%

Total 33 28 58 100% We stated that we believe giving equal wei ght to each of the Patient/Caregiver Experience measures modules is appropriate because it places greater emphasis on patient-reported experiences, promotes clinically meaningful differences in ACO perfo rmance within the domain, and is consistent with the statutory mandate to improve quality of care furn ished by ACOs over time. The proposed change would also bring the total points for the domain in line with the points available in other domains. We solicited comments on our proposal to modify the point scoring within the Patient/Caregiver Experience domain.

Comment : A majority of comments received were in support of reweighting the CAHPS measure modules. Commenters stated that assigning each measur e module equal weight would be consistent with the patient centric goals of the ACO program. We received two comments against reweighting before the end of the first ACO agreement period. These commenter s stated that the weighting should remain as it is

### CMS-1600-FC 1156

to allow ACOs to “cement this capability.” Finall y, a commenter made the comment that the CAHPS data is not timely or actionable. 

### Response : We appreciate the comments in suppor t of reweighting the CAHPS measure module scoring and, for the reasons discussed above and in the pr oposed rule, are finalizing our proposal to assign 2 points to each of the 6 CA HPS survey measure modules (12 points) instead of scoring them as one component worth only tw o points. Reweighting will take effect for the 2014 reporting period for all Shared Savings Progra m ACOs and will increase the value of the patient experience of care domain from 4 points to 14 points and result in the six survey measure module in the patient experience of care survey accounting for 86 percent of the domain score. We note that the overall domain’s weight would re main the same in relation to the other three domains, and therefore do not believe this reweig hting will impact an ACO’s ability to ‘cement’ its capabilities. Finally, we disa gree that the information gathered from the patient experience of care survey is not actionable. The survey result s, in conjunction with information derived from the ACO’s process to promote internal cost a nd quality reporting, as required under the Shared Savings Program regulations, can be used by ACOs to identify areas for improvement, monitor care for its patient population, and improve, as well as measure the ACO’s performance in this

domain.

### CMS-1600-FC 1157

K. Value-Based Payment Modifier and Physician Feedback Program

1. Overview Section 1848(p) of the Act requires that we estab lish a value-based payment modifier and apply it to specific physicians and groups of physicians the Secretary determines appropriate starting January 1, 2015 and to all physicians and groups of physicians by January 1, 2017 . On or after January 1, 2017, section 1848(p)(7) of the Act provides the Secretary discretion to apply the value-based payment modifier to eligible professionals as define d in section 1848(k)(3)(B) of the Act. Section 1848(p)(4)(C) of the Act requires the value-based payment modifier to be budget neutral. In this final rule with comment period, we are finalizing our proposed policies to continue to phase in implementation of the value-based payment modifier by applying it to smaller groups of physicians and to increase the amount of payment at risk . We also are finalizing our proposals to refine the methodologies used in our quality-tiering approach to calculating the value-based payment modifier in order to better identify both high and low performer s for upward and downward payment adjustments. We note two changes from our proposals that we are finalizing after considering the public comments we received. First, we are adopting a single pluralit y attribution approach for the Medicare Spending per Beneficiary cost measure rather than the proposed mu ltiple attribution approach. Second, we are adopting a threshold of 50 percent (rather than the proposed 70 percent) for the percentage of individual eligible professionals in a group of physicians that must me et the criteria to avoid the CY 2016 PQRS payment adjustment in order to calculate a group quality score. 2. Governing Principles for Physician Valu e-Based Payment Modifier Implementation. In the CY 2013 PFS final rule with comment pe riod (77 FR 69306), we stated that the valuebased payment modifier has the potential to help tr ansform Medicare from a passive payer to an active purchaser of higher quality, more efficient and more effective healthcare by providing upward payment adjustments under the PFS to high performing physic ians (and groups of ph ysicians) and downward adjustments for low performing physicians (and groups of physicians). We also noted that Medicare is implementing value-based payment adjustments for ot her types of services, in cluding inpatient hospital

### CMS-1600-FC 1158

services. Further, in implementing value-based pur chasing initiatives generally, we seek to recognize and reward high quality care and quality improvements, a nd to promote more efficient and effective care through the use of evidence-based measures, the reduc tion in administrative burde n and duplication, and less fragmented care. In the CY 2013 PFS final rule with comment pe riod, we established that the following specific principles should govern the implementation of the value-based payment modifier (77 FR 69307).

● A focus on measurement and alignment. Measures for the value-based payment modifier should consistently reflect differences in performan ce among physicians and phys ician groups, reflect the diversity of services furnished, and be consistent with the National Quality Strategy and other CMS quality initiatives, including the PQRS, the Medicar e Shared Savings Program, and the Medicare EHR Incentive Program.

● A focus on physician choice . Physicians should be able to choose the level (individual or group) at which their quality performance will be assessed, reflecting physicians’ choice over their practice configurations. The choice of level should al ign with the requirements of other physician quality reporting programs.

● A focus on shared accountability . The value-based payment modifier can facilitate shared accountability by assessing performance at the group prac tice level and by focusing on the total costs of care, not just the costs of care furnis hed by an individual physician.

● A focus on actionable information . The Quality and Resource Use Reports (QRURs) should provide meaningful and actionable information to he lp groups of physicians and physicians identify clinical areas where they are doing well, as well as areas in which performance could be improved by providing groups of physicians with QRURs on the quality and cost of care they furnish to their patients.

● A focus on a gradual implementation . The value-based payment modifier should focus initially on identifying high and low performing groups of physicians. Moreover, groups of physicians should be able to elect how the value-based paymen t modifier would apply to their payment under the PFS starting in CY 2015. As we gain more e xperience with physician measurement tools and

### CMS-1600-FC 1159

methodologies, we can broaden the scope of measures assessed, refine physician peer groups, create finer payment distinctions, and provide greater payment incentives for high performance. 3. Overview of Existing Policies for th e Physician Value-Based Payment Modifier. In the CY 2013 PFS final rule with comment peri od, we finalized policies to phase-in the valuebased payment modifier by applying it starting January 1, 2015 to payments under the Medicare PFS for physicians in groups of 100 or more eligible prof essionals. A summary of the existing policies that we finalized for the CY 2015 value-based payment modifi er can be found in the proposed rule (78 FR 43486 through 43488).

4. Provisions of this Final Rule with Comment Period We proposed additions and refinements to the ex isting value-based payment modifier policies. Specifically, the proposed rule in cluded the following proposals:

● To apply the value-based payment modifier to groups of physicians with 10 or more eligible professionals in CY 2016.

● To make quality-tiering mandatory for groups within Category 1 for the CY 2016 value-based payment modifier, except that groups of physicians with between 10 and 99 eligible professionals would be subject only to any upward or neutral adjustme nt determined under the quality-tiering methodology, and groups of physicia ns with 100 or more eligible professionals would be subject to upward, neutral, or downward adjustments determined unde r the quality-tiering methodology.

● To increase the amount of payment at risk under the value-based payment modifier from 1.0 percent to 2.0 percent in CY 2016.

● To align the quality measur es and quality reporting mechanisms for the value-based payment modifier with those available to groups of phys icians under the PQRS during the CY 2014 performance period.

● To include the Medicare Spending Per Bene ficiary (MSPB) measure in the total per capita costs for all attributed beneficiaries domain of the cost composite.

### CMS-1600-FC 1160

● To refine the cost measure benchmarking methodology to account for the specialties of the physicians in the group. In this final rule with comment period, we discuss each of the proposed policies, the comments received, our responses to the comments, and a brief statement of our final policy. a. Group Size In the CY 2013 PFS final rule with comment period, we stated that we would gradually phase in the value-based payment modifier in CY 2015 by firs t applying it to large gr oups (77 FR 69308), which we defined as groups of physicians with 100 or more eligible professionals. We noted our view that it would be reasonable to focus on groups with 100 or more eligible professionals before expanding the application of the value-based payment modifier to more groups and solo pr actitioners in CY 2016 and beyond. To continue our phase-in of the value-based payment modifier, we proposed to apply the valuebased payment modifier in CY 2016 to groups of physic ians with 10 or more eligible professionals. We estimated that this proposal would apply to approxim ately 17,000 groups (TINs) and nearly 60 percent of physicians under the value-based payment modifier in CY 2016. We believed this proposal would continue our policy to phase in the value-based paym ent modifier by ensuring that the majority of physicians are covered in CY 2016 befo re it applies to all physicians in CY 2017. Given the results of the statistical reliability analyses on the PQRS quality m easures and the cost measures contained in the 2010 and 2011 groups and individual QRURs (78 FR 43500 through 43502), we stated that we believed we can reliably apply a value-based payment modifier to groups of physicians with 10 or more eligible professionals in CY 2016 and to smaller groups and to so lo practitioners in future years. Accordingly, we proposed to revise the regulations at §414.1210 to reflect that the CY 2016 value-based payment modifier would be applicable to physicians that are in groups with 10 or more eligible professionals. We solicited comments on this proposal. The following is a summary of the commen ts we received regarding this proposal.

### CMS-1600-FC 1161

Comment : Several commenters supported our propo sal to apply the value-based payment modifier to groups of 10 or more eligible professiona ls in 2016. Some commenters indicated that the proposed phased approach for increasing the number of physicians to which the value-based payment modifier applies was appropriate since the statute requi res that the value-based payment modifier apply to all physicians in 2017. Many commenters were opposed to our proposed policy. Some of these commenters stated that broadening the implementation of the value-based paym ent modifier to groups of 10 or more eligible professionals so quickly is premature because CMS did not have the opportunity to assess the impact on smaller groups, while others stated that implementa tion of the value-based payment modifier should be delayed until CMS can assure the accuracy and consis tency of performance scoring. Some commenters were concerned about whether the groups that are cu rrently subject to the value-based payment modifier have enough Medicare patients to ensure that cost and quality variation is truly measuring differences in performance rather than random risks. Commenters also noted that more than 10,500 groups will be 8 or 9 months into their first performance year before th ey see one of the confidential QRURs that are the key to CMS’ value-based payment modifier outreach a nd education campaign. Other commenters suggested that there were too few subspecialist measures in the PQRS and that it would mean that small to mid-size groups would not have sufficient measures to be succe ssful in the PQRS. Other commenters stated that groups of physicians with between 10 and 24 EPs would not have a QRUR until the summer of 2014 and thus should not be subject to the value-based payment modifier. Some commenters indicated that the value-based payment modifier is yet another regulat ory burden as they transition to ICD-10. Still other comments objected to the entire concept of the valu e-based payment modifier and urged us not to implement it. Several commenters suggested that we apply the value-based payment modifier to groups of 25 or more eligible professionals or to gr oups of 50 or more eligible professionals. Response : Our focus as we gradually implement the value-based payment modifier is to increase quality measurement, because without measurement we do not believe that we ca n have consistent and sustained quality of care improvements for Medicare FFS beneficiaries. Furthermore, our approach to

### CMS-1600-FC 1162

apply the value-based payment modifier to groups of 10 or more EPs is consistent with our principle to focus on a gradual implementation of the value-based payment modifier. Therefore, we disagree with commenters’ suggestions that we not finalize our prop osal to apply the value-based payment modifier to groups of 10 or more EPs, or that we instead apply the value-based payment modifier to groups of 25 or more EPs or 50 or more EPs, because this would dela y improving quality of care furnished by groups of

10 or more EPs to FFS beneficiaries. We also continue to believe that we can validly and reliably apply a value-based payment modifier to groups of physicians with 10 or more eligible professionals in CY 2016 because we will be basing the quality score on the measures selected, and reported on, by the group of physicians or the individual EPs in the group. In addition, as discussed below, we are including an additional cost measure in the value-based payment modifier (the Medicare Spending per Beneficiary measure) and are adjusting our cost comparison appr oach to consider the medical specialty composition of the group of physicians. Moreover, based on an analysis of our CY 2012 QR URs that we made available to groups of 25 or more eligible professionals on September 16, 2 013, the PQRS quality measures and the cost measures used for the value-based payment modifier have hi gh average statistical reliability. High statistical reliability in this context means we would arrive at consistent results under simi lar conditions. Moreover, these findings corroborate the findings from our group and individual CY 2010 and 2011 QRURs (78 FR 43500 through 43502) that found high reliability among the measures used for th e value-based payment modifier. We found that the PQRS quality measures, even those reported at the individual level, were reliable; therefore, we believe that the PQRS quality measures for groups of 10 or more EPs will also be reliable. Further, because we use a minimum case size of 20 in order for a quality or cost measure to be included in the quality of care or cost composites of the value-based payment modifier, we believe that the composites will not only be valid, but also statistica lly reliable. Therefore, we disagree with the commenters’ concerns about the statistical reliability of the PQRS quality measure performance rates. Furthermore, we will continue to monitor the valu e-based payment modifier program and continue to examine the characteristic of those groups of physicia ns that could be subject to an upward or downward

### CMS-1600-FC 1163

payment adjustment under our quality-tiering met hodology to determine whether our policies create anomalous effects in ways that do not reflect cons istent differences in performance among physicians and physician groups. In the CY 2012 QRURs, we attributed, on average, 3007 beneficiaries to groups of 25 or more EPs. Moreover, approximately 65 percent of primary care services received by attributed beneficiaries were rendered by physicians in the group. Therefor e, we do not agree with commenters’ concerns about whether groups subject to the value-based payment modi fier have enough Medicare patients to ensure that the variation in cost and quality is measuring differen ces in performance rather than random risk. And, as noted above, we also use a minimum case size of 20 when including quality and cost measures in the quality of care and cost composites of the value-based payment modifier. Several commenters expressed concern regarding the number of PQRS measures applicable to subspecialists and suggested that small to mid-size groups do not have a sufficient number of measures in the PQRS to report. For purposes of the value-b ased payment modifier, we will use the performance on those measures that are reported through the PQRS reporting mechanisms adopted for the value-based payment modifier, even if fewer than three measure s are reported, to calculate a group of physicians’ quality composite score so long as the group of physicians (or at least 50 percent of the EPs in the group, if reporting as individuals under the PQRS) meet the criteria to avoid the 2016 PQRS payment adjustment. As discussed above in section H.4, we ar e modifying some of the satisfactory critieria for the 2016 PQRS payment adjustment that we believe addr esses this concern so that such physicians will not be adversely affected under the value-based payment modifier. . In response to the commenters who objected to applying the value-based payment modifier to groups of 10 or more eligible professionals because groups of 10-24 eligible professionals have not seen how they would fare under the value-based payment modifier because they will not have a QRUR until midway through the CY 2014 performance period, we note that in the late summer of 2014, we plan to disseminate QRURs based on CY 2013 data to all physicians (that is, TINs of any size). These QRURs will contain performance informati on on the quality and cost measures u sed to score the quality and cost

### CMS-1600-FC 1164

composites of the value-based payment modifier and will show how all TINs would fare under the valuebased payment modifier policies finalized in this final rule with comment period. Please note that as discussed in section III.K.4.b. below, we are also finalizing our proposed policy to hold harmless groups with 10-99 eligible professionals from any downwa rd payment adjustments under quality-tiering in CY 2016, thus shielding these groups from any downward payment adjustments in 2016.

Comment: Several commenters recommended that CMS reconsider its decision to exclude Accountable Care Organizations (ACOs) from the value-based payment modifier. These commenters indicated that ACOs should have the opportunity to be rewarded for their practice to the extent these groups provide high quality and, low cost care. Commenters recommended that ACOs be permitted to optionally participate in the value-based payment modifier or that CMS should provide a plan for addressing how innovators participating in the Medi care ACO programs will be affected by the valuebased payment modifier. Response: We finalized in the CY 2013 PFS final rule with comment period (77 FR 69313) that we will not apply the value-based payment modifier in CY 2015 and CY 2016 to groups of physicians that are participating in the Medicare Shared Savi ngs Program Accountable Care Organizations (ACOs), the testing of the Pioneer ACO model, the Comprehensive Primary Care Initiative, or other similar Innovation Center or CMS initiatives. From an operati onal perspective, we will apply this policy to any group of physicians that otherwise would be subject to the value-based payment modifier, if one or more physician(s) in the group participate(s) in one of these programs or initiatives during the relevant performance period (CY 2013 for the CY 2015 value-b ased payment modifier, and CY 2014 for the CY 2016 value-based payment modifier). We will take these comments into consideration as we develop proposals for the value-based payment modifier and ACOs in future years.

After consideration of the comments received a nd for the reasons stated previously, we are finalizing that the value-based payment modifier will apply to groups of phys icians with 10 or more eligible professionals in CY 2016.

### CMS-1600-FC 1165

We proposed to identify groups of physicians that would be subject to the value-based payment modifier (for example, for CY 2016, groups of physi cians with 10 or more eligible professionals) using the same procedures that we finalized in the CY 2013 PFS final rule with comment period (for a description of those procedures, we refer readers to 77 FR 69309 through 69310). Rather than querying

Medicare’s PECOS data base as of October 15 or anot her date certain, however, we proposed to perform the query within 10 days of the close of the PQRS group self-nomination/registration process during the relevant performance period year. We proposed to re vise the regulations at §414.1210(c) to reflect that identification of the groups of physicians subject to the value-based payment modifier is based on a query of PECOS at the close of the PQRS registration peri od and that groups of physicians are removed from this list if, based on a claims analysis, the group of physicians did not have the required number of eligible professionals, as defined in §414.1210(a) , that submitted claims during the performance period for the applicable calendar year payment adjustment period. We solicited comment on this proposal. We did not receive any comments on this proposal; therefore, we are finalizing this proposal

without modification. b. Approach to Setting the Value-Based Payment M odifier Adjustment Based on PQRS Participation

In the CY 2013 PFS final rule with comment period (77 FR 69311), we adopted a policy to categorize groups of physicians subject to the va lue-based payment modifier in CY 2015 based on a group’s participation in the PQRS. Specifically, we cat egorize groups of physicians eligible for the CY 2015 value-based payment modifier into two categori es. Category 1 includes groups that either (a) selfnominate for the PQRS as a group and report at least one measure or (b) elect the PQRS Administrative Claims option as a group for CY 2013. Groups of physicians in Category 1 may elect to have their value-based payment modifier for CY 2015 calculated using the quality-tiering methodology, which could result in an upward, neutral, or downward ad justment amount. The value-based payment modifier for groups of physicians in Category 1 that do not elect quality tiering is 0.0 percent, meaning that physicians in these groups will not receive a pa yment adjustment under the value-based payment

### CMS-1600-FC 1166

modifier for CY 2015. Category 2 includes groups of ph ysicians that do not fall within Category 1. For those groups of physicians in Category 2, the value- based payment modifier for CY 2015 is -1.0 percent. We proposed to use a similar two-category ap proach for the CY 2016 value-based payment modifier based on a group of physicians’ participa tion in the PQRS but with different criteria for inclusion in Category 1 (78 FR 43489 through 4349 0). Category 2 would include those groups of physicians that are subject to the CY 2016 value-b ased payment modifier and do not fall within Category 1. Our proposal was intended to accommodate the vari ous ways in which physicians can participate in the PQRS in CY 2014 – either as a group practice partic ipating in the PQRS GPRO or individually. We

established in the CY 2013 PFS final rule with comment period that groups of physicians that wish to participate as a group in the PQRS during CY 2014 must self-nominate and select one of three PQRS GPRO reporting mechanisms: GPRO web interface , qualified registry, or EHR (77 FR 69199-69200 (Table 93)). We also established the criteria for satisfactory reporting of data on PQRS quality measures via the GPRO for the PQRS payment adjustment for CY 2016 (77 FR 69200-69202), and we proposed to modify these criteria as described in Table 27 of the CY 2014 PFS proposed rule ( 78 FR 43370). In order to maintain alignment with the PQRS, for purposes of the CY 2016 value-based payment modifier, we proposed that Category 1 would include those groups of physicians that meet the criteria for satisfactory reporting of data on PQRS quality measures via the GP RO (through use of the web-interface, EHRs, or qualified registry reporting mechanisms) fo r the CY 2016 PQRS payment adjustment. We explained in the CY 2014 PFS proposed rule (78 FR 43489-43490) that not all groups of physicians may want to participate in PQRS as a group under the GPRO in CY 2014. These groups of physicians may prefer to have all of their eligib le professionals continue to report PQRS measures as individuals so that physicians a nd other eligible professionals in the group are able to report data on quality measures that reflect their own clinical practice. In addition, eligible professionals in these groups of physicians may wish to use different reporting mechanisms to report data for PQRS, such as the claims-based reporting mechanism, EHRs, qualified regi stries, or the proposed qualified clinical data registry reporting mechanism. Therefore, for the CY 2016 value-based payment modifier, we proposed to

### CMS-1600-FC 1167

include in Category 1 groups of physicians that do not self-nominate to participate in the PQRS as a group practice in CY 2014 and that have at least 70 pe rcent of the group’s eligible professionals meet the criteria for satisfactory reporting of data on PQRS quality measures as individuals for the CY 2016 PQRS payment adjustment, or in lieu of satisfactory repor ting, satisfactorily participate in a PQRS-qualified clinical data registry for the CY 2016 PQRS payment ad justment. Our intention with this proposal was to align the criteria for inclusion in Category 1 with th e criteria that are established for the CY 2016 PQRS payment adjustment. We also proposed to revise the regulation text at §414.1225, which was previously specific to the CY 2013 performance period and only referred to qua lity measures reported by groups of physicians rather than individual eligible professionals within a group. We solicited comment on these proposals. The following is summary of the comment s we received regarding these proposals.

Comment : The vast majority of commenters supported our proposal to continue to align the value-based payment modifier with the PQRS repor ting mechanisms and to place groups of physicians into two categories for purposes of the value-based pa yment modifier based upon PQRS participation. Several commenters suggested that such alignment was essential to reduce physician burden. Other commenters highlighted the importance of physicians c ontinuing to have the option to select the clinical quality measures via PQRS (and the appropriate re porting mechanism) that will be used for the calculation of the value-based payment modifier. Response : We appreciate commenters’ support for our proposals. One of the principles governing our implementation of the value-based paymen t modifier is to align program requirements to the extent possible. Thus, we expect to continue to align the value-based payment modifier with the PQRS program requirements and reporting mechanisms to ensure physicians and groups of physicians report data on quality measures that reflect their pr actice. We appreciate commenters’ support for our continuation of the two category approach that we proposed for the CY 2016 value-based payment

modifier.

### CMS-1600-FC 1168

Comment : Many commenters supported our proposal to include in Category 1 groups of physicians that do not participate in the PQRS as a group practice in CY 2014 but who have at least 70 percent of the group’s EPs meet the criteria for sa tisfactory reporting of data on PQRS quality measures as individuals for the CY 2016 PQRS payment adjustment, or in lieu of satisfactory reporting, satisfactorily participate in a PQRS-qualified clinical data registry for the CY 2016 payment adjustment. Commenters suggested this proposal is essential for t hose small group practices that do not participate in the PQRS GPRO and whose individual EPs have repor ted via the claims reporting mechanism for the past several years. Several commenters, however, suggest ed that we lower the proposed 70 percent threshold to 50 percent so that more groups can fall into Cate gory 1 through reporting at the individual level. Several commenters supported a lower threshold becau se of (a) the increased reporting thresholds to avoid the 2016 PQRS payment adjustment, (b) the minimal participation in the PQRS GPRO, which would make this option more attractive, (c) lack of measures for certain sub-specialists that practice in smaller groups, and (d) the transition to ICD-10. One commenter suggested th at we utilize a tiered approach by setting the threshold at 25 percent in the first year, 50 percent in the second year, and 75 percent in the third year (and thereafter) in order to allow more groups to be successful in reporting under this option. Response : We appreciate commenters’ support for our proposal to provide a way to combine individually reported PQRS measures into a grou p score for purposes of the CY 2016 value-based payment modifier. We believe that the value-based payment modifier should recognize the diversity of physician practices and the various measures used to assess quality of care furnished by these practices. We are persuaded, however, by commenters’ sugg estion to lower the 70 percent threshold to 50 percent for many of the reasons the commenters stated . We expect to propose in future rulemaking to raise the 50 percent threshold in order to provide a more comprehensive assessment of the quality of care furnished by a group of physicians across a richer set of quality dimensions.

### CMS-1600-FC 1169

By setting the threshold to 50 percent, we estimate that 76 percent of groups of physicians with between 10 and 19 EPs (based on 2011 PQRS participation) would meet the 50 percent threshold and 45 percent of groups with 100 or more EPs would meet the 50 percent threshold. Accordingly, we are finalizing our proposal to align the criteria for inclusion in Category 1 with the criteria for the CY 2016 PQRS payment adjustment as referenced above in PQRS Tables 48 and 50, which show the criteria to avoid the CY 2016 PQRS payment adjustment for group practices reporting through the GPRO and individual EPs. For the CY 2016 value-based payment modifier, Category 1 will include those groups of physicians that meet the cr iteria for satisfactory reporting of data on PQRS quality measures through the GPRO for the CY 2016 PQRS pa yment adjustment. Category 1 will also include those groups of physicians that do not register to participate in the PQRS as a group practice in CY 2014 and that have at least 50 percent of the group’s elig ible professionals meet the criteria for satisfactory reporting of data on PQRS quality measures as indivi duals for the CY 2016 PQRS payment adjustment, or in lieu of satisfactory reporting, satisfactorily partic ipate in a PQRS-qualified clinical data registry for the CY 2016 PQRS payment adjustment. For a group of physicians that is subject to the CY 2016 valuebased payment modifier to be included in Category 1, the criteria for satisfactory reporting (or the criteria for satisfactory participation, in the case of the 50 percent option) must be met during the CY 2014 performance period for the PQRS CY 2016 payment adju stment. Category 2 will include those groups of physicians that are subject to the CY 2016 value-b ased payment modifier and do not fall within Category 1. We also are finalizing our proposed revisions to the regulation text at §414.1225, which was previously specific to the CY 2013 performance peri od and only referred to quality measures reported by groups of physicians rather than individual eligible professionals within a group. We proposed to more fully phase-in the qualit y-tiering methodology for calculating the valuebased payment modifier for CY 2016 based on the number of eligible professionals in the group. We proposed that groups in Category 1 would no longer have the option to elect quality tiering for the CY 2016 value-based payment modifier (as was the case for the CY 2015 value-based payment modifier) and instead would be subject to mandatory quality tie ring. We proposed to apply the quality-tiering

### CMS-1600-FC 1170

methodology to all groups in Cate gory 1 for the value-based payment modifier for CY 2016, except that groups of physicians with between 10 and 99 eligible professionals woul d be subject only to upward or neutral adjustments derived under the quality-tiering methodology, while groups of physicians with 100 or more eligible professionals would be subject to upward, neutral, or downward adjustments derived under the quality-tiering methodology. In other words, we proposed that groups of physicians in Category 1 with between 10 and 99 eligible professi onals would be held harmless from any downward adjustments derived from the quality-tiering methodology for the CY 2016 value-based payment modifier. We stated our belief that this proposed approach would reward groups of physicians that provide high-quality/low-cost care, reduce program complexity, and more fully engage groups of physicians in our plans to implement the value-based payment modifier. Accord ingly, we proposed to revise the regulations at §414.1270 to reflect the proposal to make the quality-tiering methodology mandatory, with the exception noted above, for all groups of physicians subject to the value-based payment modifier in CY 2016 that fall within Cate gory 1. We solicited comment on this proposal.

Comment : Many commenters opposed this proposal fo r the following reasons: (1) the proposed new PQRS quality reporting mechanisms and require ments for 2014 make it difficult for groups (as identified by the Taxpayer Identification Number (TIN )) to estimate their quality score; (2) the lack of a PQRS aggregate reporting mechanism makes it difficult for medical groups that use multiple TINs to bill Medicare to report on all of its TINs using one reporti ng mechanism; (3) groups of 100 or more do not yet understand how their cost composites would change given our proposals to add a new cost measure (MSPB) and to change our peer group methodology; (4) groups of 100 or more have not yet seen their 2012 Quality and Resource Use Report, (available Se ptember 16, 2013), and which contains how they would fare under the quality-tiering methodology; an d (5) not enough time to understand the impact of the new beneficiary attribution method used in the repor ts and then to use the patient level data in the 2012 QRURs to improve performance before the next performance period (CY 2014). Some commenters supported the proposal and suggest ed that the only way to truly drive quality improvements in the health care delivery system was to measure performance on quality measures and to

### CMS-1600-FC 1171

attach payment consequences to that performance. Several commenters urged us to move away from the “pay for reporting” approach that we had adopted for the value-based payment modifier for CY 2015. Response : We are not persuaded by commenters’ concerns with our proposal to require mandatory quality tiering for calculating the valu e-based payment modifier for CY 2016 and exempt groups of physicians with betw een 10 and 99 EPs from any downward adjustments derived under the quality-tiering methodology. Based on an analysis of the CY 2012 QRURs that we made available to groups of 25 or more eligible professionals on Septem ber 16, 2013, over 80 percent of 3,876 groups for which we could compute both a quality and cost com posite score were classified as average quality and average cost, meaning no payment adjustment under the quality-tiering methodology. Slightly over 8 percent of groups of 25 or more EPs would be classifi ed in tiers that would earn an upward adjustment (11 percent of such groups would earn an additiona l bonus for treating high-risk beneficiaries) and slightly less than 11 percent of groups of 25 or more EPs would be classified in tiers that would involve a downward payment adjustment. Moreover, for the 1, 236 groups of 100 or mo re eligible professionals based on 2012 data, 68 groups would earn an upwar d adjustments (with 10 grou ps earning the additional bonus for treating high-risk benefici aries) and 88 groups would recei ve a downward adjustment using the quality-tiering methodology. These results suggest that our quality-tiering methodology identifies a small number of groups of physic ians that are outliers – both high and low performers – in terms of whose payments would be affected by the value-b ased payment modifier, thus limiting any widespread unintended consequences. In addition, we are adopt ing policies in this final rule to address certain aspects of our previously established methodologies so that beginning in CY 20 16 we better assess the group of physicians’ quality of care furnished or the cost of that care. These policies include our refinement of the cost composite peer group methodol ogy and the use of PQRS quality data reported by individual EPs. As explained above in section III.K.4.a, we will continue to monitor the value-based payment modifier program and continue to examine th e characteristics of those groups of physicians that could be subject to an upward or downward paym ent adjustment under our quality-tiering methodology

### CMS-1600-FC 1172

to determine whether our policies create anomalous effects in ways that do not reflect consistent differences in performance among ph ysicians and physician groups. To address commenters’ specific concerns about mandatory quality tiering, we believe groups of physicians will report data for quality measures unde r PQRS on which they expect their performance would be high, regardless of whether it is a new re porting mechanism or the reporting requirements may have changed for CY 2014. Thus, we disagree with th e assertion that groups of physicians must receive a QRUR from CMS before they can understand th eir performance on quality measures on which they choose to report data. Notwithstanding this obser vation, the PQRS since 2007 has provided feedback reports to physicians on their pe rformance on reported quality measures so that physicians can see how they compare against others who report the same measures. We also disagree with commenters who suggest that we do not have a quality reporting system that allows large health systems that use multiple TINs to bill Medicare to use one method. The Medicare Shared Savings Program provides a way for large systems (a) to use one reporting mechanism that aggregates their multiple TINs into one organization, (b) to fulfill their PQRS obligations, and (c) to earn savings for furnishing high quality /

low cost care. Further, on September 16, 2013, we made availabl e to all groups of 25 or more EPs an annual QRUR based on 2012 data to help groups estimate thei r quality and cost composites, thus groups of 100 ore more eligible professionals have had access to their reports. Moreove r, these reports provide beneficiary specific information, including hospitaliza tion information for attributed beneficiaries that enables groups of physicians to examine which bene ficiaries are driving performance on quality outcome measures and the cost measures. We intend to provi de QRURs to all groups of physicians and solo practitioners during the summer of 2014 (based on 2013 performance) that include their performance on the MSPB measure and the new peer group methodologies. Thus, we believe all groups of 100 or more have, or will soon have, the data n ecessary to begin to improve perfo rmance. Although we are sensitive to providing groups of physicians with adequate lead time to unders tand the impact of the beneficiary attribution method used for the value-baed payment m odifier, we believe our polic y of holding groups of

### CMS-1600-FC 1173

between 10 and 99 EPs harmless from any downwa rd payment adjustment would likely mitigate unintended consequences that could occur. In additio n, the attributed beneficiaries in the 2012 QRURs had, on average, at least three primary care services furnished by physicians in the group. We believe such information could help groups of physicians est imate which beneficiaries in their patient population may be attributed to them prior to receiving a QR UR that includes data from the relevant performance period.

Comment : Many commenters appreciated the policy to hold harmless groups of physicians with between 10 and 99 EPs from any negative payment adjustments and supported our proposal. A few commenters suggested that applying the value-based payment modifier negative payment adjustment only to groups of 100 or more EPs is an unjust paym ent methodology because CMS is not holding smaller group practices to the same quality standards as larg er group practices. Several commenters also suggested that by eliminating the negative paym ent adjustment for small group practices, CMS is decreasing the maximum incentive amount a high quality/low cost large group practice could receive under the quality-tiering approach. Response : We appreciate commenters’ support for our proposal. Our focus as we implement the value-based payment modifier is to increase qua lity measurement, because without measurement we

do not believe that we can have consistent and sustained quality of care improvements for Medicare FFS beneficiaries. Large groups practices are more likel y to have the ability and means to track and monitor quality of care and resource use whereas many smaller groups are now just developing these capabilities. Thus, we believe it is appropriate to hold groups of physicians with between 10 and 99 EPs harmless from any downward adjustments, whic h is similar to the policy we are applying to groups of 100 or more EPs during the first year the value-based payment modifier applies to them (2015). We recognize that until the value-based payment modifier is fully impl emented, with both upside and downside adjustment applied to all groups of physicians and solo practitioners, we will have disparate impacts and the pool of money available for upward adjustments will be reduced . We believe, however, th is policy is consistent

### CMS-1600-FC 1174

with our overall approach to gradually phase in th e value-based payment modifier and reinforces our goal to increase quality reporting while not increasing reporting burdens on physicians. For these reasons, we are finalizing our proposal th at groups of physicians in Category 1 will not have the option to elect quality tiering for the CY 2016 value-based payment modifier and instead will be subject to mandatory quality tiering. We also are finalizing our proposal that groups of physicians in Category 1 with between 10 and 99 eligible prof essionals will be held harmless from any downward adjustments derived from the quality-tiering methodology for the CY 2016 value-based payment modifier. We are also finalizing the revision to the regulations at §414.1270 to clarify that for the CY 2015 payment adjustment period a group may be de termined under the quality-tiering methodology to have low performance based on low quality and high co sts, low quality and average costs, or average quality and high costs. c. Payment Adjustment Amount Section 1848(p) of the Act does not specify the amount of payment that should be subject to the adjustment for the value-based payment modifier; how ever, section 1848(p)(4)(C) of the Act requires the value-based payment modifier be implemented in a budget neutral manner. B udget neutrality means that payments will increase for some groups of physicia ns based on high performance and decrease for others based on low performance, but the aggregate amount of Medicare spending in any given year for physicians’ services will not change as a result of application of the value-based payment modifier. In the CY 2013 PFS final rule with comment peri od, we adopted a modest payment reduction of 1.0 percent for groups of physicians in Category 1 that elected quality tiering and were classified as low quality/high cost and for groups of physic ians in Category 2 (77 FR 69323-24). As discussed in the CY 2014 proposed ru le (78 FR 43500 through 43502), we conducted statistical reliability analysis on the PQRS quality measures and the co st measures contained in the 2010 and 2011 group and i ndividual QRURs. These QRURs contained the quality measures that were reported under the PQRS and five per capita cost measures that we will use for the value-based payment modifier. The quality and cost measures in the group QRURs were very statistically reliable. Moreover, the

### CMS-1600-FC 1175

average reliability was high for 98 percent of the individua lly reported PQRS measures and for all of the cost measures (with a case size of at least 20) includ ed in the individual QRUR s. Thus, we noted our belief that we can increase the amount of payment at risk because we can reliably apply a value-based payment modifier in CY 2016 to groups of physicia ns with 10 or more eligible professionals and to smaller groups and to solo practitioners in future years. Therefore, we proposed to increase the downward adjustment under the value-based paymen t modifier from 1.0 percent in CY 2015 to 2.0 percent for CY 2016. That is, for CY 2016, a -2.0 percent value-based payment modifier would apply to groups of physicians subject to the value-based payment modifier that fall in Category 2. In addition, we proposed to increase the maximum downward adjust ment under the quality-tiering methodology to -2.0 percent for groups of physicians classified as low qua lity/high cost and to set the adjustment to -1.0 percent for groups classified as either low quality/aver age cost or average quality/high cost. We proposed to revise §414.1270 and §414. 1275(c) and (d) to reflect the proposed increase to a 2.0 percent adjustment under the value-based payment modifier for the CY 2016 payment adjustment period. We also made a technical correction to §414.1275(c) to clarify th e PQRS GPRO reporting mechanisms available in CY 2013. Table 85 shows the proposed quality-tiering payment adjustment amounts for CY 2016 (based on CY 2014 performance). Table 85: 2016 Value-Based Payment Modifier Amounts CY 2016 Cost/Quality Low quality Average quality High quality Low cost +0.0% +1.0x* +2.0x* Average cost -1.0% +0.0% +1.0x* High cost -2.0% -1.0% +0.0% * Groups of physicians eligible for an additional +1.0 x if reporting Physician Qua lity Reporting System quality measures and average beneficiary risk score is in the top 25 percent of all beneficiary risk scores. Consistent with the policy adopted in the CY 2013 PFS final rule with comment period, the upward payment adjustment factor (“x”) would be determined after the performance period has ended based on the aggregate amount of downward payment ad justments. We noted that any funds derived from the application of the downward adjustments to groups of physicians with 100 or more eligible

### CMS-1600-FC 1176

professionals and the downward 2.0 percent adjustment applied to those groups of physicians subject to the value-based payment modifier that fall in Category 2, would be available to all groups of physicians eligible for value-based payment modifier upw ard payment adjustments. The quality-tiering methodology would continue to prov ide an additional upward payment adjustment of +1.0x to groups of physicians that care for high-risk beneficiaries (a s evidenced by the average HCC risk score of the attributed beneficiary population). We solicite d comments on our proposal to increase the downward value-based payment modifier to 2.0 percent for tho se groups of physicians with 10 or more eligible professionals that are in Category 2 an d for groups of physicians with 100 or more eligible professionals that are classified as low quality/high cost gr oups for the CY 2016 payment adjustment period. The following is summary of the comment s we received regarding this proposal.



### Comment : A number of commenters supported our proposal to increase the amount of payment at risk under the value-based payment m odifier in CY 2016. Some commenters stated that the payment adjustment must be of significa nt weight in order to drive physician behavior toward achieving high quality and low cost care. A few commenters sugge sted that the valuebased payment modifier should represent a larg er percentage of physician payments under the PFS and stated that the amount of the payment di fferential should be closer to 10.0 percent, increased incrementally from 2.0 percen t and subject to annual review. Many commenters, however, were opposed to our proposed policy. Several commenters suggested that CMS should not in crease the amount of payment at risk under the value-based payment modifier in CY 2016 and recommended k eeping the amounts at the CY 2015 levels. A few commenters urged CMS to delay increasing the maximum downward adjustment under the program until at least CY 2017 to allow CMS to gain experience with applying the value-based payment modifier to a broader variety of groups, and to allow physician groups to increase their understanding of their performance under quality-t iering. Some commenters suggested keeping

### CMS-1600-FC 1177

the downward adjustments for groups subject to the value-based payment modifier at -1.0 percent during the first year and then increasing it to -2.0 percen t during the second year. Some commenters indicated that groups th at report data and choose to elect quality-tiering should not be at the same risk as groups that did not report at all. Some commenters also indicated that a large number of physicians could see both a two percent PQRS and a tw o percent value-based payment modifier adjustment in 2016, and when added to a potential two percent sequester reduction, and possibly another two percent EH R adjustment, this could push some older physicians to retire or close their practices to Medicare patients. One co mmenter indicated that it does not agree that the size of PQRS and valu e-based payment modifier adjustments is the driving factor in physicians’ decisions on whethe r to participate in th ese incentive programs. Response : We agree with the commenters who stat ed that the amount of payment at risk should be higher than the 1.0 per cent amount of payment at risk in 2015 in order to incentivize physicians to provide high quality and low cost care. Our experience u nder PQRS has shown us that a 1.0 or 2.0 percent incentive payment was insu fficient to obtain widesp read participation in the PQRS, thus, we believe that we need to in crease the amount of paymen t at risk for the CY 2016 value-based payment modifier in order to incentivize physicians and groups of physicians to report PQRS data, which will be used to calculate the value-based payment modifier. Therefore, we are finalizing our proposal to increase the maxi mum downward adjustment for the CY 2016 value-based payment modifier to 2.0 per cent for those groups of physicians with 10 or more eligible professionals that are in Category 2 and for groups of physicians with 100 or more eligible professionals that are in Category 1 and are classified as low quality/high cost groups.

We also believe that our final policy, as described above in sec tion III.K.4.b, to calculate for a group of physicians the performance on PQRS qualit y measures reported by individual eligible

### CMS-1600-FC 1178

professionals in the group will enable more groups to fall under Category 1 and avoid Category 2’s automatic -2.0 percent payment adjustment. Even though several comme nters suggested that we increase incrementally the amount of payment at risk to 10 percent, we believe that it is premature in this final rule w ith comment period to lay out the roadmap for future years as suggested by these commenters.

After consideration of the comm ents received and for the re asons stated previously, we are finalizing our proposed po licies as described above.

d. Performance Period

In the CY 2013 PFS final rule with comment period (77 FR 69314), we adopted a policy that performance on quality and cost measures in CY 2014 will be used to calculate the valuebased payment modifier that is applied to item s and services for which payment is made under the PFS during CY 2016. We received comments in response to the CY 2013 PFS proposed rule requesting that we close the gap between the end of the performance period (for example, December 31, 2014) and the beginning of the paymen t adjustment period (for example, January 1, 2016), in order to strengthen the connection between the performance of physicians and groups of physicians and the financia l incentives for quality improvement. 3 

### We understand that many private sector plans start to provide paymen t adjustment within 7 months of close of the performance period. 4 

### Since the payment adjustment periods for th e value-based payment modifier are tied to the PFS, which is updated on an annual calendar y ear basis, options to close the 1-year gap between the close of the performance period and the start of the payment adjustment period are

3 See, e.g., Comment of the American College of Surgeons comment on the CY 2013 PFS proposed rule (Aug. 31, 2012). 4 US GAO, Medicare Physician Payment: Private-Sector Initiatives Can Help Inform CMS Quality and Efficiency Incentive Efforts, GAO-13-160 (Dec. 2012), available at http://www.gao.gov/assets/660/651102.pdf

.

### CMS-1600-FC 1179

limited and primarily are centere d around altering the start and end dates of the performance period. As discussed previously in section III.H. of this fina l rule with comment period, one option could be to adjust the performance peri od for quality data reported through the PQRS. In addition, we could calculate the total per capita cost measures on an April 1 through March 31 basis, thus closing the gap by 3 months. However, a byproduct of altering the performa nce periods is that the deadline for submitting quality information would have to oc cur promptly at the end of the performance period. In addition, the review pe riod during which groups of physicians will be able to review the calculation of the value-based payment modifi er would be shortened to allow the necessary system changes to implement the adjustment by the January 1 deadline for implementation of the annual PFS. We solicited comment on the potentia l merits of altering our current performance periods. We proposed to use CY 2015 as the performance period for the value-based payment modifier adjustments that will apply during CY 2017. We believe it is important to propose the performance period for the payment adjustment s that will apply in CY 2017, because section 1848(p)(4)(B)(iii) of the Act requi res all physicians and groups of physicians to be subject to the value-based payment modifier beginning not later than January 1, 2017. Accordingly, we proposed to add a new paragraph (c) to §414.1215 to indicate that the performance period is CY 2015 for value-based payment modifier adjustments made in the CY 2017 payment adjustment period. We solicited comment on this proposal. The following is a summary of the comments we received.

Comment : Many commenters expressed the opin ion that shortening the gap between the performance year and the adjustment year for the value-based payment modifier by 3

### CMS-1600-FC 1180

months does not represent a sign ificant improvement. Commenters indicated that CMS should continue to seek ways to reduce the current 1- year gap between the close of the performance period and the beginning of the payment adju stment period. A number of commenters recommended that CMS adjust the performance period for quality data reported through PQRS and calculate the total per capita cost measures on an April 1 through March 31 basis, thus closing the gap by 3 months. Other commenters indicated that the increasing use of the new PQRS qualified clinical data re gistry reporting option can provide a window to reduce this gap considerably, a rolling 12-month cycle reported on a quarterly basis may be most effective for measurements with small sample populations, an d a longer period of time may be required to show any improvement. Response : A majority of the commenters did not support the option to adjust the performance period for quality data reported thro ugh PQRS and calculate th e total per capita cost measures on an April 1 through March 31 basis a nd claimed that closi ng the gap by 3 months would not be a significant improvement. Also, there was not sufficient support among commenters for reporting PQRS data on a quarter ly basis because it would be operationally difficult and burdensome on physicians. Therefore, we are finalizing a policy to use CY 2015 as the performance period for the value-based paymen t modifier adjustments that will apply during CY 2017. In the meantime, we will continue to consider options to close the gap between the performance period and the payment adjustment period and will continue to provide timely feedback to physician groups through the QRURs. One potential mechanism to close the gap would be to require quarterly re porting by eligible prof essionals or to truncate the time allowed for reporting after the performance period closes ; however, we have not received comments from physicians and other clinicians s upporting these approaches. Moreove r, we believe it is critical

### CMS-1600-FC 1181

to calculate cost measures using a full 90 day cl aims runout so that measures accurately assess the cost of care. We encourage stakeholders to share their thought s and ideas on options to close the gap without imposing an undue administrative burden and while still allowing for meaningful quality and costs measurement. In the meanti me, we expect that groups of physicians will become even more proficient at the use of EHR technology and establish real-time feedback on quality measures so that they have relevant pe rformance information that they can act on at the point of care. e. Quality Measures

In the CY 2013 PFS final rule with comme nt period (77 FR 69315), we aligned our policies for the value-based payment modifier for CY 2015 with the PQRS reporting mechanisms available to groups of physicians in CY 2013, such that data that a group of physicians submitted for quality reporting purposes through any of the PQRS group reporting

mechanisms in CY 2013 would be used for calcu lating the quality compos ite under the qualitytiering approach for the value-based payment modi fier for CY 2015. Moreover, all of the quality measures for which groups of physicians are e ligible to report under the PQRS in CY 2013 are used to calculate the group of physicians’ value-based payment modifier for CY 2015, to the extent the group of physicians submits data on such measures. We also established a policy to include three additional quality measures (out come measures) for all groups of physicians subject to the value-based paymen t modifier: (1) a composite of rates of potentially preventable hospital admissions for heart failure, chronic obst ructive pulmonary diseas e, and diabetes; (2) a composite rate of potentially preventable hos pital admissions for de hydration, urinary tract infections, and bacterial pneumoni a, and (3) rates of an all-cause hospital readmissions measure (77 FR 69315).

### CMS-1600-FC 1182

PQRS Reporting Mechanisms : We noted in the proposed ru le that we believe it is important to continue to align the value- based payment modifier for CY 2016 with the requirements of the PQRS, because quality repo rting is a necessary component of quality improvement. We also seek not to place an undue burden on physicians to report such data. Accordingly, for purposes of the value-based payment modifier for CY 2016, we proposed to include all of the PQRS GPRO reporting mechanis ms available to group practices for the PQRS reporting periods in CY 2014 and all of the PQRS reporting mechanisms available to individual eligible professionals for the PQRS reporting peri ods in CY 2014. In addition, we proposed that groups of physicians with 25 or more eligible prof essionals would be able to elect to include the patient experience of care measures collected through the PQRS CAHPS survey for CY 2014 in their value-based payment modifier for CY 2016. These reporting mechanisms are described in Tables 24 through 27 of the CY 2014 PFS propos ed rule (78 FR 43367-43370). We also proposed to update our regulations at §414.1220 to reflect this proposal. We noted in our proposal that the criteria for satisfactory re porting of data on PQRS quality measures for individual eligible professionals via qualified registries for the CY 2014 PQRS incentive and CY 2016 PQRS payment adjustment permits the use of a 6-month reporting period. We stated that we believed that data submitted via qualified re gistries for this 6-month reporting period would be sufficiently reliable on which to base a gr oup of physicians’ quality composite score under the value-based payment modifier because in order for us to use the data to calculate the score, we would require data for each quality measure on at least 20 beneficiaries, which is the reliability standard for the value-based payment modifi er (77 FR 69322-69323). Gi ven this level of reliability, we believe a 6-month reporting pe riod would be sufficient for the purpose of evaluating the quality of care furnished by a gr oup of physicians subject to the value-based

### CMS-1600-FC 1183

payment modifier. We solicited comment on this proposal. The following is a summary of the comments we received on this proposal.

Comment : The majority of commenters supported our proposal to permit groups practices and individual EPs to use all of the PQRS reporting mechanisms available to them in CY 2014 for the value-based payment modifier, in cluding the use of the PQRS CAHPS survey.

Commenters indicated that there should be a wide range of reporting options available in order to increase participation in the PQRS. Others commenters urge d us to the retain the PQRS Administrative Claims reporting option that we have in place for CY 2013 and to include in Category 1 those groups of physicians that elect the Administrative Claims option. Response : We appreciate the comments recei ved in support of our proposal. As discussed previously, one of the principles governing our implementation of the value-based payment modifier is that physicia ns should be able to choose the level (individual or group) at which their quality performance will be asse ssed, reflecting physicians’ choice over their practice configurations. We believe that th e various PQRS reporting mechanisms – which include both individual and group reporting mech anisms allow physicians to choose how best to report quality information given their practice co nfiguration. In respons e to the commenters’ suggestion that we continue to use the PQRS Administrative Claims reporting option for the value-based payment modifier, we believe this option does not match our long-term goals to encourage reporting by physicians a nd groups of physicians of quality measures that best match their practices. In addition, our analysis of the CY 2012 QRURs show s that average reliability is substantially higher for the PQRS measures reported by physicians and groups of physicians than the reliability of many of the 14 Ad ministrative Claims measures.

### CMS-1600-FC 1184

Accordingly, we are finalizing our proposal to include for the CY 2016 value-based payment modifier all of the PQ RS GPRO reporting mechanisms av ailable to group practices for the PQRS reporting periods in CY 2014 and all of the PQRS reporting mechanisms available to individual eligible professionals for the PQRS reporting periods in CY 2014. In addition, we are finalizing our proposal that groups of physicians with 25 or more e ligible professionals would be

able to elect to include the patient experience of care meas ures collected through the PQRS CAHPS survey for CY 2014 in their value-ba sed payment modifier for CY 2016. We are finalizing the corresponding cha nges to § 414.1220 as proposed. PQRS Quality Measures : We also proposed to use all of the quality measures that are available to be reported under these various PQRS reporting mechanisms, including quality measures reported through qualifie d clinical data registries, to calculate a group of physicians’ value-based payment modifier in CY 2016 to the extent that a group of physicians submits data

on these measures. We noted that the three outco me measures that we finalized in the CY 2013 PFS final rule with comment period and in §414.1230 – the two composites of rates of potentially preventable hospital admissions a nd the all-cause hospita l readmission measure –

would continue to be included in the quality measures used for the value-based payment modifier

in CY 2016. For those groups of physicians subject to th e value-based payment modifier in CY 2016 whose eligible professionals pa rticipate in the PQRS as indi viduals rather than as a group practice under the GRPO (that is , groups of physicians that are assessed under the finalized 50 percent threshold), we proposed to calculate the group’s performance rate for each measure reported by at least one eligib le professional in the group of physicians by combining the weighted average of the performance rates of th ose eligible professiona ls reporting the measure.

### CMS-1600-FC 1185

We noted that if all of the eligible prof essionals in a group of physic ians subject to the CY 2016 value-based payment modifier satis factorily participate in a PQRS qualified clinical data registry in CY 2014 and we are unable to receive qua lity performance data for those eligible professionals, for purposes of the value-based pa yment modifier, we proposed to classify the group’s quality composite score as “average” under the quality-tiering methodology, because we would not have data to reliably indicate whether the group should be classified as high or low quality under the quality-tiering methodology. We al so proposed to add a new subsection to our regulations at §414.1270 to reflect our proposals about how to assess quality performance for groups assessed under the proposed 70 percent thres hold ((which is being finalized as 50 percent, as discussed above). We solic ited comment on these proposals. The following is a summary of the comments we received regard ing these proposals.

Comment : Most commenters supported use of all PQ RS measures available to groups of physicians and individual physicia ns and eligible professionals for the CY 2014 PQRS reporting periods. The commenters appreciated “CMS’ fl exibility in allowing performance on all PQRS measures to be included in the value-based pa yment modifier.” Several commenters expressed concern over the lack of measures in the PQRS measure set that are appropriate for certain specialties and urged that these specialties not be penalized under the value-based payment modifier solely based on the limited availability of quality measures for those specialties. One commenter, however, suggested th at rather than straining Medicare’s limited resources to implement dozens of process measures and shortening reporting times, we should use a small number of outcome measures (calculated at th e population level within a specified geographic area) that are important to taxpayers and benefi ciaries for the value-based payment modifier.

### CMS-1600-FC 1186

We did not receive comments on our proposal to calculate a group’s performance rate for each measure reported by at least one eligib le professional in the group of physicians by combining the weighted average of the perfor mance rates of those e ligible professionals reporting the measure. Despite the lack of comments on ho w we should calculate a group score when EPs in the group report PQRS quality m easures as individuals , commenters cited our proposal to address the potential scenario of not receiving data from qualified clinical data registries as a “reasonable way” to tier groups whose EPs report using a PQRS qualified clinical data registry in CY 2014. Response : We appreciate commenters’ support for our proposals. We believe that the PQRS measure set is robust and, as described above, we have incl uded new measures to address measure gaps (section III.H.9. above). In addi tion, we have collabora ted with the specialty

societies in order to increase the number of meas ures available specifically for specialists. We appreciate the suggestion to use a small numb er of outcome measures calculated at the population level, and we will continue to examin e ways to add to the three outcome measures that we currently utilize for the value-ba sed payment modifier as we continue our implementation of the value-based payment modifier. We also note that we expect to receive data in a timely manner for EPs who report using qualified clinical data registries (see discussion above section III. H). For that reason, it is not absolutely necessary that we finalize our propos al to classify as “average” under the qualitytiering methodology a group of physicians subject to the CY 2016 value-based payment modifier that falls under Category 1 and whose indivi dual EPs satisfactorily participate in a PQRS qualified clinical data registry in CY 2014. Nonetheless, out of an abundance of caution, we are

### CMS-1600-FC 1187

finalizing the proposal as a precau tion to address the s cenario where in fact we would be unable

to receive data in a timel y manner for a group’s EPs. Accordingly, we are finalizing our proposal to use all of the quality measures that are available to be reported under the various PQRS reporting mechanisms to calculate a group of physicians’ CY 2016 value-based payment modifier to the extent that the group (or individual EPs in the group, in the case of th e 50 percent threshold option) submits data on those measures. We also are finalizing our proposal for those groups of physicians availing themselves of the “50 percent threshold option” discussed above to ca lculate the group’s performance rate for each measure reported by at least one eligible prof essional in the group of physicians by combining the weighted average of the performance rates of those eligible prof essionals reporting the measure. In addition, for those groups assessed under the “50 percent th reshold option,” we are finalizing our proposal to classify a group’s qua lity composite score as “average” under the quality-tiering methodology, if all of the eligible professionals in the group satisfactorily participate in a PQRS qualified clinical data registry in CY 2014 and we are unable to receive quality performance data for those eligible profe ssionals. We clarify that if some EPs in the group report data using a qualified cl inical data registry and we ar e unable to obtain the data, but other EPs in the group report data using claims , registry, or EHR reporting mechanism, we would calculate the group’s scor e based on the reported performance data that we obtain through claims, registries, or EHRs. We are finalizi ng our proposed addition to the regulations at §414.1270 without modification. We noted that when the value-based paymen t modifier applies to all physicians and groups of physicians in CY 2017 based on pe rformance during CY 2015, we anticipate continuing our policy to align with the PQRS gro up reporting for all groups of physicians of two

### CMS-1600-FC 1188

or more eligible professionals, and we anticipate permitting physicians who are solo practitioners to use any of the PQRS reporting mechanisms available to them under the PQRS for reporting periods in CY 2015 for purposes of the value-ba sed payment modifier in CY 2017. Although we did not propose to adopt this policy, we solicited comment on this approach to align certain aspects of the CY 2017 value-based payment modi fier with the quality measures and reporting mechanisms used in the PQRS.

Comment : Commenters supported the approach to align the CY 2017 value-based payment modifier with the PQRS quality measures and the available PQRS reporting mechanisms. The commenters recognize that with the PQRS they have a c hoice of measures that serve as the basis for assessment. They also believe that alignment between the PQRS and the value-based payment modifier helps to minimi ze administrative burden to physician practices. Commenters encouraged “CMS to continue in future rulemaking cycles to allow physicians the flexibility to choose measur es that are applicable to their scope of practice.” Response : We appreciate the commenters’ support for our overall approach to the CY 2017 value-based payment modifier. We anticip ate making proposals in future rulemaking to apply the value-based payment modifier to a ll physicians and groups of physicians in 2017. f. Inclusion of the Medicare Spending per Beneficiary Measure in the Value-Based Payment Modifier Cost Composite In the CY 2014 PFS proposed rule, we summari zed the five cost measures that we previously finalized for the value-based paymen t modifier cost composite and restated our previously expressed belief that the value-based payment modifier should incorporate additional

measures that are consistent with the Na tional Quality Strategy and other CMS quality initiatives. As a step toward that goal, beginning with the CY 2016 value-based payment

### CMS-1600-FC 1189

modifier, we proposed to expand the cost com posite to include an a dditional measure, the Medicare Spending per Beneficiar y (MSPB) measure (with one modi fication as discussed in the CY 2014 PFS proposed rule) (78 FR 43493 through 94). We proposed that the MSPB measure would be added to the total per capita costs for all attributed beneficiaries domain of the valuebased payment modifier. We proposed that the MSPB measure would be equally weighted with

the other cost measure in that domain - the total per capita cost measure. We stated that the rationale for our proposal to in clude the MSPB measure in the total per capita costs for all

attributed beneficiaries domai n, rather than the total per cap ita costs for all attributed beneficiaries with specific condi tions domain, was that the MSPB measure is similar to the total per capita costs measure. In addition, we stated our intent to propose, in future rulemaking, to replace the four measures in the total per capita costs for all attributed beneficiaries with specific conditions

domain with cost measures derived from th e CMS Episode Grouper and other episode-based

costs. We solicited comments on these potential changes to the c ondition-specific cost measures

as well as on the other elements of the co st composite in preparation for the CY 2015 performance period affecting payment adjustment year CY 2017. In the proposed rule, we provided background on the MSPB measure, which we have already finalized for inclusion in the Hospital Inpatient Quality Reporting (IQR) and Value-Based Purchasing (VBP) Programs. We stated that, when viewed in lig ht of other quality measures, as a part of the valuebased payment modifier measure set, we believe that inclusion of the MSPB measure would enable us to align incentives and similarly recognize physician groups involved in the provision of high-quality care at

a lower cost to Medicare.

Construction of the MSPB measure

. In the CY 2014 PFS proposed rule, we summarized the

construction of the MSPB measure used for the Hospital IQR and VBP Programs (78 FR 43494). We

### CMS-1600-FC 1190

stated that the measure includes all Medicare Part A and Part B payments during an MSPB episode spanning from 3 days prior to an index hospital admi ssion through 30 days post discharge with certain exclusions. Costs for each episode are risk adjusted and the included payments are standardized to remove differences attributable to geographic paym ent adjustments and other payment factors. The payment standardization is the same methodology u sed for the existing total per capita cost measures included in the value-based payment modifier. We explained that, under the Hospital IQR and VBP Programs, the payment-standardized costs for all i ndex admissions are summed and divided by the sum of the expected costs from the risk adjustment model. This ratio is then multiplied by the national average MSPB episode cost to give the hospital’s MSPB amount . We then divide an individual hospital’s MSPB amount by the national median MSPB amount to calcu late a ratio, which we publicly report on Hospital Compare and use to generate a measure score fo r the Efficiency domain under the Hospital VBP Program. We referred readers to the FY 2012 IPPS/ LTCH PPS final rule (76 FR 51618 through 51627) for a detailed description of the MSPB measure used in the Hospital IQR and VBP Programs and noted that a detailed specification document (entitled “MSPB Measure Information Form”) and the payment standardization methodology (entitled “CMS Price Standardization”) can be found in the “Measure Methodology” section at http://qualitynet.org/dcs/ContentServer?c=Page&p agename=QnetPublic%2FPage%2FQnetTier3&cid=12

28772053996

. We proposed a slightly revised calculation for incl usion of the MSPB measure in the value-based payment modifier. We proposed not to convert the MSPB amount to a ratio as is done to compute a hospital’s MSPB measure under the Hospital IQR an d VBP Programs, but rather to use the MSPB amount as the measure’s performance rate. We solicite d comment on our proposals to include the MSPB measure (as modified per the discussion above) in the value-based payment modifier cost composite and to add the measure to the total per capita costs for all attributed beneficiaries domain. We also proposed to revise the regulations at §414.1235 to include th e Medicare Spending per Beneficiary measure in the set of cost measures for the value-based payment modi fier and §414.1260(b)(1)(i) to include the Medicare

### CMS-1600-FC 1191

Spending per Beneficiary measure in the total per capita costs for all attributed beneficiaries domain. We received many comments on our proposal to include th e MSPB measure as a part of the cost composite for the Physician Value-Based Payment Modifier beginning with the CY 2014 performance period and CY 2016 payment adjustment year.

Comment : Many commenters opposed our proposal to include the MSPB measure in the cost composite. While several of these acknowledged the im portance of promoting efficiency for physicians and incentivizing coordination of care and reduction in delivery syst em fragmentation, they expressed reservations regarding implementation of the measu re for the CY 2014 performance year and the CY 2016 value-based payment modifier. The reasons given for the lack of support for this measure’s addition to the cost composite included: lack of experien ce with this measure as it applies to physicians and physician groups, with the sugges tion that it first be piloted or included in PQRS or Quality and Resources Use Reports (QRURs) before it is included in the value-based payment modifier; lack of NQF endorsement; perceived lack of physician control ove r care plan; concerns about actionability, that is,

whether the information from the measure can be used by physician groups to improve performance; or perceived lack of measure specification or testing at the physician level. One commenter suggested that the measure first be piloted on populations with clear ly inappropriate spending patterns. One commenter questioned the applicability of the measure to physic ian groups practicing in dedicated cancer centers, and two expressed that measure variation was not reflective of pathology services. One of these commenters suggested that the Hospital VBP Program total perform ance score for the hospital in which a pathologist practices should be used in the value-based payment modifier, rather than the MSPB measure rate. Response : We agree with the commenters that c oordination of care and reduction of delivery system fragmentation are important goals and inclus ion of this measure in the value-based payment modifier is an important step toward incentivizing quality improvements. We also agree that it is important for physician groups to gain experience with the measure . Accordingly, we will begin including information on the MSPB measure (that is, performance rate, beneficiary information) in the QRURs that will be disseminated to all groups in 2014 based on 2013 performance (and going forward),

### CMS-1600-FC 1192

before it is included in the CY 2016 value-based pa yment modifier that will adjust physician groups’ payments based on 2014 performance. We also note that during the first year the measure is included in the value-based payment modifier, groups of physici ans with 10-99 eligible professionals in Category 1 will not receive any downward payment adjustments under the quality-tiering methodology. Because we are finalizing our proposal to “hold harmless” groups of physicians with 10-99 EPs in Category 1 from any downward payment adjustment in CY 2016, we be lieve this policy addresses commenters’ concerns, because it means that these groups will have at least 2 years’ experience with the measure before it could affect payments. We believe that piloting the measure is not necessary, because hospitals already are being assessed with this measure under the Hospita l IQR and VBP Programs, and we seek to align incentives among hospitals and physicians as quickly as possible. We thank the same commenter for the suggestion to use the total performance score for the hospital in which a pathologist practices rather than the MSPB measure, and will take this proposal under consideration in future rulemaking. While groups of 100 or more eligible professionals could poten tially receive a downward payment adjustment under the CY 2016 value-based payment modifier (based on th eir CY 2014 performance), those groups also will have received a QRUR of their measure performance in advance of the performance being used in the value-based payment modifier. We also note that a ll groups of 25 or more eligible professionals were able to obtain a QRUR based on CY 2012 performan ce that provided detailed information about the beneficiaries attributed to their groups. These 2012 reports provided details about the beneficiaries’ hospitalizations, so that physician groups may begin to work with the hospitals that treat their attributed beneficiaries to improve care coordination, decrease fr agmentation, and improve efficiency. We believe that these steps are sufficient to a llow physician groups to gain experience with the MSPB measure and do not believe that it would be necessary to first im plement the measure on some subset of physician groups that might be expected to ha ve inappropriately high spending. We disagree that the measure is not adequately specified for application to physician gr oups. As we noted in the proposed rule (78 FR 43494), the measure’s detailed specifications are av ailable in the “Measure In formation Form” located under the “Measure Methodology” section on Quality Net

### CMS-1600-FC 1193

( http://www.qualitynet.org/dcs/ContentServer?page name=QnetPublic%2FPage%2FQnetTier3&cid=1228

772053996 ). We disagree with commenters’ suggestion that physicians have little control over the care provided to beneficiaries who are hospitalized. As noted by some commenters on this proposed rule, as well as on the FY 2013 IPPS proposed rule, there is va lue in aligning incentives between hospitals and the physicians who practice in them. We acknowledge that physician groups may contribute to the MSPB episode cost to varying degrees. As discussed in more detail below, we are finalizing an attribution methodology that we believe addresses commenters’ c oncerns regarding the degree to which a given physician group contributed to the costs for a give n MSPB episode. By attributing episodes included in the MSPB measure only to the physician group that provided the plurality of Part B services during the hospital stay, we believe we are recognizing the group of physicians that is in a strong position to improve coordination, decrease fragmentation, and control Me dicare expenditures. In addition, the physician group that provided the plurality of Part B services duri ng the stay is in a strong position to coordinate care with the hospital, addressing commenter concer ns about measure actionability discussed above. While we appreciate the value of NQF endorsement, we note that it is not required for inclusion of a measure in the value-based payment modifier. We intend to submit the physician version of the MSPB measure through a future endorsement project; however, at this time, we have proposed a measure that is substantially similar to that currently undergoing the NQF endorsement process, which is a measure used to assess spending for hospitals, rather than physicia n groups. We believe that inclusion of the MSPB measure in the value-based payment modifier will he lp to align incentives and promote coordination of care and improved efficiency across provider types, including hospitals and the physician groups who practice in them. We do not believe it would be appropriate to ex clude any physician specialty from inclusion in the measure, as such an exclusion could undermine the effort to incentivize care coordination. We also

note that the MSPB measure is built around index ad missions at IPPS hospitals, not PPS-exempt cancer hospitals.

### CMS-1600-FC 1194

Comment : Several commenters expressed their suppor t for inclusion of the MSPB measure in the cost composite. The reasons these commenters provide d for their support included: the belief that a

robust cost measure set will further transform the Medicare payment system to a system that rewards efficient, effective care and helps a ddress the critical issue of health care; valuing consistency with the use of this measure in the Hospital VBP Program; and the belief that inclusion of this measure could incentivize team-based care among hospitals and their physicians, including improved discharge planning better discharge instructions and education. One commenter also noted that measurement using the MSPB measure enables providers to develop thei r own care delivery processes in order to improve performance on the measure. One commenter suppor ted the inclusion of the MSPB measure while suggesting that CMS also continue to explore how cost measures for specific conditions or treatments might be used to further expand the cost composite. Response : We thank the commenters for their support of our proposal to include the MSPB measure in the cost composite for the value-based payment modifier. We agree that this measure’s inclusion will contribute to the continued developmen t of a more robust cost measure set for the valuebased payment modifier and that it will incent improved care coordination among physicians and hospitals, improved efficiency, and control of health care costs, and it will help to align incentives across our incentive payment programs. We agree that con tinuing to expand the cost composite measure set would benefit the value-based payment modifier, and we will consider including specific episode cost measures through future rulemaking.

Comment : We received several comments related to the construction of the MSPB measure itself. One commenter expressed concern with th e measure’s inability to assess physician groups and their ability to avoid hospitalization for their patients, while several suggested th at the risk adjustment methodology should go further to address factors incl uding: socioeconomic status, dual eligibility for Medicare and Medicaid, a frailty factor, functional status, sub-specialty of the physician; place of service; or CPT codes, rather than Major Diagnostic Categor ies (MDCs). A few commen ters expressed concern that a lack of specialty mix could penalize physici an practices that focus on home health, skilled nursing

### CMS-1600-FC 1195

facility care, or rehabilitation. A few commenters stat ed that a measure of provider-level care would be more reliable than one of facility-level or mixed fac ility- and provider-level care. A few commenters also expressed concern that the measure does not include Part D data. Finally, a few commenters expressed

concern that the fact that the MSPB measure does not reflect other aspects of care quality could lead to the unintended consequence of reduced access to or provision of needed care or avoidance of complex patients. One of these commenters suggested that M SPB should therefore not be weighted more heavily than patient experience or outcome measures. 

### Response : We appreciate the commenters’ consid eration of the MSPB measure, and we will continue to consider ongoing refinements to it, as we gain experience with the measure. We proposed to use the MSPB amount as the measur e rate under the physician value-based payment modifier, rather than converting it to a ratio as we do under the Hospital IQR and VBP Programs. For each cost measure finalized for use in the physician value-based payment modifier, including the MSPB amount, we also are finalizing use of a specialty adjustment that allows for peer group comparisons while factoring in specialty mix (see section III.K.4.g.2. be low). The specialty adjustments are made to risk-adj usted dollar amounts, ra ther than to ratios such as those used under the Hospital IQR and VBP programs. Aside from that proposed difference in expression of the measure rate, we believe that it is impor tant to maintain the measure’s construction as closely as possible to that used under the Hosp ital VBP and IQR Programs, in the interest of alignment across programs and to provide consis tent information to both hospitals and their physicians so that they are assessed against the same yardstick. We disa gree that inclusion of this measure would incentive physic ians to reduce provision of need ed care to the beneficiaries they serve and avoid hospitaliza tions. As we stated in the FY 2013 IPPS/LTCH Final Rule (77 FR 53586), we do not believe that the Medicare Spending per Beneficiary measure itself should assess both cost and quality. We believe that a distinct measure of cost, independent of quality,

### CMS-1600-FC 1196

enables us to identify providers involved in the provision of high qua lity care at a lower cost to

Medicare. Because the MSPB m easure would be only one of six measures included in the valuebased payment modifier’s cost composite, we be lieve that physicians’ consideration for their patients’ well-being as well as their performance on the other measures used for the value-based payment modifier would outweigh any potential incentive to re duce needed care to Medicare

beneficiaries. We therefore believe that a cost composite weight that is equal to the quality composite weight provides a balance between ince ntives for physician groups to improve quality and to control cost. We will monitor for changes in utilization patterns. We disagree that the costs of care provided in the faci lity should be separated from t hose provided post-discharge. This would be counter to the goal of incentivi zing coordination betweenhospitals and physician group to ensure that Medicare beneficiaries rece ive effective, efficient care during and after hospitalization. We refer the reader to section III.K.4.g.2., Cost Composite Benchmarking and Peer Groups, for a discussion of the specialty adjustment for the MSPB measure, which addresses the commenter suggesti on about specialty adjustment. That adjustment is made

outside the construction of the M SPB measure itself and will be performed after the measure is calculated for a group of physicians. We do not believe that payments included in the MSPB measure should be adjusted for differences in site of service, as these differences reflect actual costs to the Medicare program. The payments in cluded in the measure are adjusted according to the CMS Price Standardization methodology located at http://www.qualitynet.org/dcs/ContentServe r?c=Page&pagename=Qn etPublic%2FPage%2FQne

tTier4&cid=1228772057350 , and they are standardized to re move differences attributable to geographic payment adjustments and other paymen t factors. Because many Medicare fee-forservice beneficiaries obtain outpa tient prescription drug coverage outside of Medicare Part D,

### CMS-1600-FC 1197

including Part D data in the M SPB measure would inco rrectly indicate higher costs for these beneficiaries compared to others. We are considering possible approaches to paymentstandardizing and operationalizing Part D costs. Regarding the comments related to the MSPB’s risk adjustment methodology, we addressed simila r comments in the IPPS/LTCH Final Rule and refer readers to that discussion (77 FR 53586 through 53588). We did not receive any comm ents on our proposed regulation text changes at §414.1235 or §414.1260(b)(1)(i) and are, therefore, finalizi ng the proposed changes without modification.

Attribution of the MSPB measure to physician groups . In the CY 2014 PFS proposed rule, we proposed to attribute an MSPB episode to a group of physicians subject to the valuebased payment modifier (as identified by a single TIN), when any eligible professional in the group submits a Part B Medicare claim under th e group’s TIN for a service rendered during an inpatient hospitalization that is an inde x admission for the MSPB measure during the performance period for the applicable calendar year payment adjustment period. Thus, the same index admission and MSPB episode could be attri buted to more than one group of physicians.

We stated that attribution of the MSPB episode to all groups of physicians from which an eligible professional submits a Part B claim for a service rendered during the hospitalization is the best way to assign responsibility for, and en courage greater coordinati on of, care furnished to

Medicare beneficiaries who are hospitalized. We stated that, based on CY 2011 claims data, the proposed approach would enable approximately 11,419 groups of physicia ns with at least 10 eligible professionals to have an MSPB measure score included in their cost composite (78 FR 43494). We noted that many of these groups w ould otherwise not rece ive a cost composite score, because they do not provide the requisite pr imary care services of th e five annual total per capita cost measures and, therefore, are not attributed be neficiaries. We stated that our proposed

### CMS-1600-FC 1198

approach incentivizes hospitals and physicians to furnish effici ent, effective care during a hospitalization and to coordina te post-discharge care to a void unnecessary services and preventable readmissions. Furthe r, we believe that this attri bution approach fosters shared accountability between hospitals and physicians for the care they furnish to Medicare beneficiaries who are hospitali zed. We proposed to add a new paragraph (b) to §414.1240 to indicate that a MSPB episode would be attribut ed to a group of physicians subject to the valuebased payment modifier if any eligible professional in the group submits a Part B Medicare claim under the group’s TIN for a service rendered dur ing an inpatient hospita lization that is an index admission for the MSPB measure during the performance period for the applicable calendar year payment adjustment period. Gr oups of physicians would have a Medicare Spending per Beneficiary measure score included in their cost composite based on the proposed attribution methodology for the MSPB. In the CY 2014 PFS proposed rule, we also sought comment on the alternative MSPB measure attribution approaches. We considered attributing an MSPB episode to a physician group when any eligible professional in the group b illed a Part B claim for a service rendered at any time during the Medicare Spending per Beneficiar y episode (that is, from 3 days prior to an index admission through 30 days post- discharge). We stated that th is attribution approach would place an even stronger emphasis on shared a ccountability for care provided to Medicare beneficiaries who are hospitalized, both duri ng and after their hosp italization. Based on 2011 claims data, we estimate that this attribution approach would enable an additional 3,017 groups of physicians with 10 or more eligible professi onals to receive an M SPB measure performance rate for inclusion in the cost composite, as comp ared to our proposed attribution approach which considers only those eligible professionals who bill a Part B claim during the index admission.

### CMS-1600-FC 1199

As with our proposed approach, the same index admission and MSPB episode could be attributed to more than one group of physicians under this alternative approach. We welcomed public comment on the alternativ e attribution approach under wh ich we would attribute an MSPB episode to a physician group if any eligible prof essional in the grou p billed a Part B service during the 3 days prior to an index ad mission through 30 days post hospital discharge.

We also considered two alternative methods which would attribute each MSPB episode to a single physician group. The MSPB episode could be attributed solely to the group of physicians that provided the plur ality of Part B services either : (1) during the entire MSPB episode (that is, from three days prior to an index admission through 30 days post discharge); or (2) during the index admission only. We wish to clarify the explanati on of “plurality” of services that we provided in the proposed rule. By “plurality,” of services, we mean the highest

total Medicare allowed amount for Part B se rvices billed by any group of physicians who provided Part B services during a given portion of an MSPB episode (either the full episode or the index admission only). The group of physicians need not have billed the majority of the charges allowed by Medicare for Part B services furnished during a given portion of an episode, but rather the group’s total allo wed charges must be greater th an any other group of physicians for that portion of the episode. These methods are single attribution approaches, unlike our proposal which is a multi-a ttribution approach. Using 2011 claims, we analyzed the number of TINs, comprised of 10 or more eligible professionals, that would be attributed an MSPB measure rate under these alternative attribution methods given a minimum of 20 MSPB episodes required. Our analyses revealed that 7,799 TINs (out of approximately 17,000 TINs) would be e ligible to receive an MSPB measure rate, if MSPB episodes were attributed to the group of physicians that provi ded the plurality of

### CMS-1600-FC 1200

Medicare Part B services during the entire MSPB episode. This represents a 46 percent decrease

in the number of TINs that would receive an M SPB measure rate, were it attributed to a group from which an eligible professional rendered any Part B service during th e entire episode. Our analysis also showed that 7,582 TINs would be el igible to receive an MSPB measure rate, if MSPB episodes were attributed to the physician gr oup that billed the plurality of Medicare Part B payments during the index admission. This repr esents a 34 percent decrease in the TINs that would receive an MSPB measure rate, were it attributed to a group from which an eligible professional rendered any Part B se rvice during the index admission. In the proposed rule, we explained that we considered these two single attribution methods because they represent methods to id entify groups of physicians that were “most responsible” for the Part B Medicare payments made during the episode . We did not propose these methods, because we believed our propos ed multiple attribu tion approach better incentivizes a team approach to accountability for Medicare beneficiaries’ care during a hospitalization. We stated our be lief that our proposed attribution approach is further supported by the higher number of TINs that will be able to receive an MSPB measure rate under that methodology. We solicited comment, however, on these two alternativ e single attribution approaches we considered: Attributing an MSPB episode to the group of physicians that provided the plurality of Part B services billed either during the entire MSPB episode or during the index admission only. In the proposed rule, we also explained two versions of a “hybrid” attribution method we considered. This methodology would attribute MSPB episodes to all TINs from which an eligible professional provided services representing at least 35 percent of the total Medicare Part B payments made either: (1) during the entire MSPB episode (that is, from three days prior to an

### CMS-1600-FC 1201

index admission through 30 days post discharge); or (2) during the index admission only. This

alternative could result in multiple attribution, if two eligible professionals from different TINs each provided services representing at least 35 percent of the Part B Medicare payments during one of the episode portions described above (e ither the full episode or during the index admission only). The rationale for this attributio n approach is that it ensures that the MSPB measure would be attributed to a group of phys icians who had responsib ility for a significant portion of the Medicare be neficiary’s care during a given por tion of the MSPB episode. We did not propose this alternative, because we believed that our proposed attribution approach better incentivizes a team approach to accountability fo r Medicare beneficiaries’ care during and after a hospitalization. We welcomed pub lic comment on this alternative attribution approach based on provision of services representing at least 35 percent of Medicare Part B payments made either during the entire MSPB episode or during the index admission only. The following is a summary of the comment s we received regarding the proposed

attribution method and alternative methods.

Comment : One commenter tentatively supporte d our proposal to attribute MSPB episodes to any physician group from which an e ligible professional bill ed a Part B service during an index admission for the MSPB measure. A few commenters stated that they would prefer either single attribution ba sed on the plurality of Part B serv ices during the hospital stay or attribution based on the “hybrid” approach of attributing to a ny group from which an eligible professional provided at least 35 pe rcent of the Part B services b illed during the hospital stay. One commenter supported attributio n based either on plurality of Pa rt B services provided during the hospital stay or on a hybrid a ttribution during either the hospita l stay or the entire episode. The majority of commenters stated that they wo uld prefer attribution to a single physician group

### CMS-1600-FC 1202

that provided the plurality of Part B services dur ing the hospital stay. The commenters expressed their belief that our proposed attribution to any physician group from which an eligible professional billed a Part B claim during the i ndex admission or episode was too broad, stating that it would not recognize physic ian groups’ varying degrees of involvement in the patient’s care during the episode, that it would not incentivize coordination of care, that the physician group to which the episode is attributed should have a minimum level of association with the patient’s care, and that further analysis was needed before ad opting such a broad attribution approach. One commenter expressed concern th at attribution could inadvertently penalize inpatient physicians (for exam ple, hospitalists) for costs bey ond their control such as those occurring in the post-acute and outpatient set tings or those incurred by specialists due to inadequate primary care. One commenter asked that we ensure that calculations used to specifically allocate costs asso ciated with physician care versus care provided for the same patient in other settings or by other physicians/specialists are calculated and attributed accurately. One commenter stated that the m easure could routinely penalize physicians whose practices focus on care settings su ch as nursing home or home care. One commenter stated that attribution should not be based on plurality of E&M services, and one commenter asked for

clarification on how the measure would be attribut ed to groups that span a state or multiple regional hospitals. Response : After considering the comments we rece ived, we have decided not to finalize the attribution methodology that we proposed and instead will fi nalize the alternative, single attribution methodology that we co nsidered, wherein an MSPB episode is attributed to the physician group (as identified by the Tax Identification Number) that furnished the plurality of Part B services during the index admission. This approach was the one most favored by

### CMS-1600-FC 1203

commenters. This approach recognizes physicia n groups’ varying degrees of involvement in the patient’s care during the episode, incentivizes co ordination of care, and helps ensure that the physician group to which the episode is attributed has a minimum level of association with the patient’s care. We are finalizing this policy in appreciation of the commenters’ concern that the group to which an episode is attributed should have been involved in a si gnificant portion of the beneficiary’s care. The hospital and the physicia n group providing the plurality of care during the hospitalization will be best able to coordi nate care and discharge and reduce fragmentation and unnecessary service provision. We believe this approach a ddresses commenters’ concerns that a specialist might be attribut ed an episode for which they were not primarily responsible. We also prefer this attributi on approach to one in which th ere is a set minimum level of involvement (such as the “hybrid” 35 percent approach we considered), because such an alternative attribution approach could result in some episode s not being attributed to any physician group, because the groups with the pl urality of care did not reach the minimum percentage of care (for example, 30 percent). We believe that omitting such episodes from the

measure would be counter to our interest in incentivizing a team approach to care provision for the beneficiaries with the most complicated cases. We do not intend to attribute portions of an MSPB episode to different physician groups depending on the setting in which the care was pr ovided, as suggested by one commenter. The

MSPB measure is not constr ucted in that manner. Rather, it is attributed to an entity that is responsible for provision of a significant portion of the beneficiary’s ca re and is capable of improving the efficiency of care throughout the epis ode. We do not believe the plurality of care during the stay approach to attribution will have a disproportionately adverse effect on those physician groups involved primarily in provision of home health or skilled nursing facility care,

### CMS-1600-FC 1204

because the physician whose group is attributed th e episode must have provided more in-hospital care than any other physician. We wish to clarify that attribut ion of the MSPB measure would not be based on plurality of E&M services, but on plurality of all Part B services furnished during the index admission. In the case of a large physician group spanning multiple regions, the same policy would apply and the episode would be attributed to the TIN that billed the plurality of Part B services during th e index admission. We appreciate the commenters’ request for additional analysis of the effect of the attribu tion options we considered. As described in the proposed rule, we discussed the differences in th e number of TINs that would receive an MSPB measure rate using a single attribution methodol ogy based on plurality of care during the index admission, as compared to the number of TINs th at would receive an MSPB measure rate under our proposed multiple attribution approach. We conducted additional analyses on the application of a minimum percentage of Medicare allowed ch arges that a physician group must have billed in order to be attributed an ep isode. As compared to a single attribution based on plurality with no minimum percentage, a multiple attribution appro ach requiring a group to have billed at least 35 percent of Medicare allowed ch arges resulted in a decrease fr om 7,582 attributed TINs to 7,389 attributed TINs, a decrease of 2.5 percent. This reduction is minimal, because while the floor precludes attribution of some episodes, multiple attribution allows some episodes to be

attributed to more than one TIN. We found mini mal difference in the nu mber of TINs receiving an MSPB measure rate under the single attribut ion based on plurality and the multiple attribution based on a minimum 35 percent of charges appr oaches. Since imposing a minimum floor such as 35 percent of charges would lead to havi ng un-attributed MSPB episodes that are not supported by these findings, we are finalizing the attribution appro ach recommended by the majority of commenters - a single attribution ba sed on plurality of Part B services during the

### CMS-1600-FC 1205

hospital stay with no floor. As stated previously, we believe th at attributing the MSPB episode to the physician group that provided the plurality of care dur ing the hospitaliza tion is the best approach to recognizing the group of physicians in the best position to affect improved coordination, decrease fragmentation, and control Medicare expenditures. We will monitor and examine the effects of this attribution appro ach as we implement the MSPB measure and may consider changes to this polic y through future rulemaking. Reliability standard for the Medicare Spe nding per Beneficiary measure for the valuebased payment modifier. We proposed that a group of physicia ns would have to be attributed a minimum of 20 MSPB episodes during the performa nce period to have their performance on this measure included in the value-based payment mo difier cost composite. Table 86 shows the MSPB measure’s reliability at various minimum numbers of episodes for all Medicare-enrolled TINs with at least one EP (not just TINs of 10 or more eligible professionals) from May 2011 through December 2011. (We note that Table 86 doe s not consider the speci alty adjustment that we are finalizing in section III.K.4.g.2. below.) In th is context, reliability is defined as the extent to which variation in the measure’s performance rate is due to variation in the cost of services furnished by groups of physicians rather than random variation due to the sample of cases observed. Potential reliability va lues (known in statistics as th e correlation coefficient) range from zero to one, where one (highest possible re liability) signifies that all variation in the

measure’s rates is the result of variation in the difference in performance across groups of physicians and is not due to random variation. Generally, reliabilities in the 0.40-0.70 range are often considered moderate and values greater than 0.70 high.

### CMS-1600-FC 1206

TABLE 86: Reliability of Medicare Spending per Beneficiary Measure for all TINs with at Least One Eligible Professional (May 2011- December 2011)

MSPB Episodes Attributed Number of TINs Percent of TINs Mean risk-adjusted standardized cost per MSPB episode Average Reliability

1-9 59,419 47% $20,493 0.65 10-19 12,332 10% $21,260 0.79 20-29 7,774 6% $21,225 0.83 30-39 5,839 5% $21,340 0.85 40-49 4,511 4% $21,324 0.87 50-99 12,648 10% $21,353 0.89 100-124 3,702 3% $21,403 0.91 125-149 2,761 2% $21,342 0.92 150-174 2,134 2% $21,316 0.93 175-199 1,673 1% $21,119 0.93

200+ 14,933 12% $20,562 0.96



### We also considered a minimum number of 10 episodes. The advantage of this lower

minimum number is that it would enable us to calculate the MSPB measure for an additional 12,332 physician groups once we apply the value-base d payment modifier to all physicians and groups of physicians. With a minimum of 10 cas es, the measure is still very reliable, as illustrated in the Table 86. We proposed the mi nimum of 20 cases for initial implementation of this measure in the cost composite beginning with the CY 2016 value-ba sed payment modifier because it strikes a balance between maintaining hi gh reliability and includ ing a large number of physician groups. We noted that this reliabilit y standard we proposed is the same one we adopted in the CY 2013 PFS final rule with comm ent period that applies to quality and cost measures used in the value-based payment modifier (77 FR 69323). We welcomed public comment on our proposed minimum of 20 episodes for inclusion of the Medicare Spending per Beneficiary measure in the cost composite fo r the value-based paymen t modifier and on the alternative 10 episode minimum that we considered.

### CMS-1600-FC 1207

Comment : We received several comments on our proposed 20 episode minimum and the alternative 10 episode minimum we considere d. Several commenters supported a minimum of 10 cases, in order to enable more groups to re ceive an MSPB measure performance rate for inclusion in the cost composite. These commente rs noted that the MSPB measure is still very

reliable at 0.70 with a minimum of 10 cases. Se veral commenters also stated that the proposed minimum of 20 cases was appropriate. One comm enter suggested a minimum of 30 cases would be appropriate. Response : We agree that the MSPB measure is s till very reliable with a minimum of 10 cases, and we recognize that increasing the cost composite measure set for physician groups is a positive outcome of reducing the case minimum fr om our proposed minimum of 20. We believe that, because the measure is new, and a minimum of 20 cases still allows a substantial number of physician groups to have an MSPB measure rate in their cost composites, the proposed minimum of 20 cases is most appropriate for this measur e’s initial inclusion in the value-based payment

modifier. We believe that a minimum of 20 cases strikes a good bala nce between preserving high reliability and maximizing the number of ph ysician groups that receive an MSPB measure rate as part of their cost co mposite. After consideration of all public comments on the inclusion of the MSPB measure in the cost composite for the CY 2016 physician value-based payment modifier, we are finalizing the following policies: We proposed a slightly revised calculation for inclusion of the MSPB measure in the value-based payment modifier. We proposed not to convert the MSPB amount to a ratio as is done to compute a hospital’s MSPB measure unde r the Hospital IQR and VBP Programs, but rather to use the MSPB amount as the measure’s performance rate.

### CMS-1600-FC 1208

We are finalizing inclusion of the MSPB m easure as proposed in the cost composite beginning with the CY 2016 value-based payment modifier, with a CY 2014 performance period. As we proposed, we will use the MSPB am ount as the measure’s performance rate rather than converting it to a ratio as is don e under the Hospital IQR and VBP Programs. We are finalizing that the MSPB measure will be added to the total per capita costs for all attributed beneficiaries domain and equally weight ed with the total per ca pita cost measure. It will not be added to the total per capita costs fo r all attributed beneficiaries with specific

conditions domain. We are finalizing the method under which an M SPB episode will be attributed to a single group of physicians that provides the plurality of Part B servi ces during the index admission, for the purpose of calculating that group’s MSPB measure rate. We are finalizing a minimum of 20 MSPB ep isodes for inclusion of the MSPB measure in a physician group’s cost composite. We are finalizing regulat ion text as proposed at §414.1235 and §414.1260(b)(1)(i). We are finalizing the regulati on text at §414.1240(b) to read: For the MSPB measure, an MSPB episode is attributed to the group of physicians subject to the value-based payment modifier whose eligible professionals submitte d the plurality of claims (as measured by allowable charges) under the group’s TIN for Medicare Part B services, rendered during an inpatient hospitalization that is an index admi ssion for the MSPB measur e during the applicable performance period described at §414.1215. g. Refinements to the Cost Measure Composite Methodology (1) Average Cost Designations in Certain Circumstances

### CMS-1600-FC 1209

In the CY 2013 PFS final rule with comment period (77 FR 69322), we established a policy to create a cost composite for each gr oup of physicians subject to the value-based payment modifier that includes five payment-st andardized and risk-adj usted annual per capita cost measures. To calculate each group’s pe r capita cost measures, we first attribute beneficiaries to the group of physicians. We attr ibute beneficiaries using a two-step attribution methodology that is used for the Medicare Shar ed Savings Program and the PQRS GPRO and that focuses on the delivery of primary care se rvices (77 FR 69320). We have observed that groups of physicians that do not provide primary car e services are not attri buted beneficiaries or

are attributed fewer than 20 bene ficiaries and, thus, we are unable to calculate reliable cost measures for those groups of physicians (77 FR 69323). Given this development, we proposed that, to the extent that we are unable to attribute a sufficient numb er of beneficiaries to a group of physicians subject to the value-ba sed payment modifier and thus are unable to calculate any of

the cost measures with at leas t 20 cases, the group of physicians’ cost composite score would be classified as “average” under the quality-tie ring methodology. We believe this policy is reasonable because we would have insufficient information on which to classify the group of physicians’ costs as “high” or “low” under th e quality-tiering methodology. Moreover, we believe that to the extent a group of physicians’ quality composite is clas sified as “high” or “low,” the groups of physicians’ value-based paymen t modifier should reflec t that classification. Accordingly, we proposed to add a new paragr aph at §414.1270 to reflect this proposal that groups of physicians in Category 1 for which we attribute fewer than 20 cases to calculate any cost measure would have their cost composite classified as “average” cost. We solicited comment on this proposal. The following is su mmary of the comments we received regarding this proposal.

### CMS-1600-FC 1210

Comment : The majority of comments received on this proposal were from commenters who supported our proposal and agre ed that this was a reasonab le proposal because CMS would have insufficient information to classify the grou p’s cost as high or low, and other assumptions would be unfair to practices attributed fewer th an 20 beneficiaries. The few commenters who opposed the proposal believed th at it would unfairly advantag e physician groups that have unnecessarily high costs and disadva ntage providers who provided exceptional care at very low costs. One of the two commenters who opposed this proposal suggested that CMS could remove costs from the value-based payment modifier determination for such groups. Response : We continue to believe that groups that are attribut ed fewer than the minimum

case size of 20 beneficiaries would not allow for th e calculation of reliable cost measures. We are concerned that not classifyi ng the group as average when it has fewer than 20 attributed

beneficiaries would increase the likelihood that its cost measur es could fluctuate greatly from year to year, so we disagree with some of th e commenters who stated that it would unfairly advantage or disadvantage di fferent physician groups.

After consideration of the comm ents received, we are finali zing our proposal and adding a new paragraph at §414.1270 to reflect the proposal that groups of physicians in Category 1 for

which we attribute fewer than 20 cases to calcul ate any cost measure have their cost composite classified as “average” cost.

Comment : Some commenters expresse d or reiterated previously stated concerns about CMS’ use of total per capita cost measures for the value-based payment modifier. In the CY 2012 PFS final rule with comment period (76 FR 73434) , we finalized the use of total per capita cost measures and per capita cost measures fo r beneficiaries with f our chronic conditions (chronic obstructive pulmonary disease, coronary artery diseas e, diabetes, and heart failure) in

### CMS-1600-FC 1211

the value-based payment modifier. In the CY 2013 PFS final rule with comment period (77 FR 69318), we finalized the use of the CMS Hierarch ical Condition Category (HCC) model to risk adjust these total per capita cost measures in the value-based paymen t modifier. Arguments against the total per capita cost measures that commenters raised in response to the CY 2014 PFS proposed rule included that the cost measures reflect the total amount billed per patient by

Medicare overall rather than the amount billed per patient by just the medical group, may not be appropriate for some specialists , and was not developed for nor tested in physician practices. Some commenters expressed concerns that the risk adjustment used in the total per capita cost measures is inadequate, either because of concerns about the CMS Hierarchical Condition Category (HCC) model or because the risk adjust ment method lacked adjusters for physicians that tend to treat non-compliant patients. One commenter requested that CMS ensure that the expenditures are adjusted for geograp hic differences in input costs. Other concerns raised by commenters included the potential for groups to shift drug costs from Part B to Part D, since Part D is not included in the cost measure. Several other commenters requested that CMS not use total pe r capita cost measures in the value-based modifier until we have developed and tested mo re focused episode-based cost measures. One commenter expressed concern a bout potential problems in shifti ng from the ICD-9-CM to the ICD-10-CM system, since the HCC model assigns prior year ICD-9-CM diagnosis codes to 70 high cost clinical conditions. Response : We continue to believe that the tota l per capita cost measures provide useful information and are appropriate to incent physician groups who are in a good position to oversee annual costs to do so. We refer readers to prev ious CMS responses to a number of concerns raised again this year (about, for example, the appropriateness of the total per capita cost

### CMS-1600-FC 1212

measure for some specialists and the adequacy of the risk adjustment used for the measure) that were discussed in the CY 2012 (76 FR 73433 through 73436) and CY 2013 PFS final rules (77 FR 69315 through 69318). We also reiterate that th e total per capita cost measures are paymentstandardized (77 FR 69316 through 69317), which removes regional or local price differences that may lead to cost variation that a physicia n group cannot influence. We are aware of the commenters’ concerns with total per capita cost measures and the risk adjustment approach, and we will monitor the situation as we implement th e value-based payment modifier. If warranted, we will propose modifications to the total per capita cost measures and the risk adjustment approach in future rulemaking. Regarding the potential to shift drug costs fr om Part B to Part D, we will take this

comment into consideration as we monitor the impacts when the value-based payment modifier is implemented. Regarding testing episode-based cost measures, we have not yet proposed using output from the CMS episode grouper – that is cu rrently under development and discussed in the Physician Feedback Program section (see sect ion III.K.5.c.) – in the value-based payment modifier. We will consider proposing to include episode-based cost measures in future years’ value-based payment modifiers (beyond 2016) through future rulemaking after we have thoroughly tested the CMS episode grouper and groups have seen their performance on them. We believe, however, that total pe r capita cost is a useful meas ure of total volum e of healthcare

services to Medicare beneficiar ies and encourages shared account ability for beneficiary care and

we have shared the results of this measure with all groups of 25 or more eligible professionals. Therefore, we disagree with the commenters who are calling for a delay in the use of the total per capita cost measure in the value-based payment modifier. Finally, we are studying the impacts of the planned ICD-9 to ICD-10 conve rsion across the Medicare program.

### CMS-1600-FC 1213

Comment : Some commenters expre ssed concerns about CMS using cost measures that have not been endorsed by the National Quality Forum (NQF), while others stated agreement

with some of the concerns about the total per capita cost measure that were raised by the NQF

Cost and Resource Use Committee (for example, concerns about the total per capita cost measure’s reliability, vali dity, and usability, as well as lack of inclusion of Part D costs in the measure). One commenter expressed appreciati on to CMS for taking a thoughtful approach to the implementation of the cost measures (via NQF submission). Response : We submitted the total per capita cost measure for NQF endorsement in January 2013. (For further information, please see materials related to the submission of NQF candidate measure #2165 (Payment -Standardized Total Per Capita Cost Measure for Medicare Fee-for-Service (FFS) Beneficiaries) in the Cost and Resource Use 2012: Phase 1 section of the NQF website – http://www.qualityforum.org/Projects/cd/Cost_and_Resource_2012_Phases_1_and_2/ Cost_and_Resource_Use_2012__Phase_1.aspx#t =2&s=&p=5%7C .) In the final voting in September 2013, the NQF Cost and Resource Use Committee narrowly voted against the measure by a count of 12 in support and 13 in opposition. We anticipate addressing the Committee’s concer ns in future rulemaking, especially regarding our attribution model and how best to incorporate socioeconomic status in our measure, after the NQF provides additional guidance regarding risk adjustment for resource use measures. Consistent with the policy we established in the CY 2013 PFS final ru le, we will continue to use the total per capita cost measures in the value-based payment modifier, and we will

continue to evaluate the measure methodol ogy and update the meas ure as appropriate. (2) Cost Composite Benchmarking and Peer Groups

### CMS-1600-FC 1214

Once we calculate the cost measures for each group of physicians subject to the valuebased payment modifier, we create the cost co mposite by calculating a standardized score for each cost measure and then placing the measures in to one of two equally weighted domains: (1) the total per capita costs for all a ttributed beneficiaries domain; a nd (2) the total per capita costs for attributed beneficiaries with specific conditio ns domain. This standardized score is referred

to in statistical terms as a Z-score. To arrive at the standardized score for each cost measure, we compare the performance for each group’s cost m easures to the benchmark (national mean) of other groups subject to the value-based payment modifier (peer group) for the same performance year. Specifically, we calculate the benchmark fo r each cost measure as the national mean of the performance rates among all groups of physicians to which beneficiaries are attributed and that are subject to the value-ba sed payment modifier. Using 2011 claims data, we examined the dist ribution of the overall total per cap ita cost measure among all groups of physicians with one or more eligible professionals to determine whether comparisons at the group level would be appropriate once we apply the value-based payment modifier to smaller groups of physicians and solo practitioners . We found that our current peer grouping methodology c ould have varied impacts on gr oups of physicians that are comprised of different physician specialties. This result occurs because the peer group for the per capita cost benchmarks is based on a national mean calculated among all groups of physicians subject to the value modifier rather than determined more narrowly (for example, within a physician specialty). To address this issue beginning with the CY 2016 value-based payment modifier, we considered two methods that account for the gr oup practice’s specialty composition so that our quality-tiering methodology produces fair peer group comparisons and, ultimately, correctly

### CMS-1600-FC 1215

ranks group of physicians based on actual perfor mance. Taking account of physician specialties in making cost comparisons is similar to the approach we have used in the CY 2010 and CY 2011 Quality and Resource Use Reports (QRURs) fo r individual physicians in which we made cost comparisons at the individual physician specialty level. The first method, “specialty adjustment,” accounts for the specialty composition of the group prior to computing the standardized score for each cost measure. This method enables us to develop comparable benchmarks for the risk-adj usted cost measures against which to evaluate groups of physicians of smaller size who often have fewer or single specialty composition. More specifically, this met hod adjusts the standardized sc ore methodology to account for a group’s specialty composition using three steps: Step 1 : Create a specialty-specific expected cost based on the national average for each cost measure (referred to as the “national specialty-specific expected costs”). To do so, we attribute beneficiaries to a gr oup using the plurality of primary care services methodology that

we finalized in the CY 2013 PFS final rule with comment period (77 FR 69316). For each specialty, we calculate the average cost of benefi ciaries attributed to groups of physicians with that specialty, weighted by the number of EPs in each group. Step 2 : Calculate the “specialty-adjusted expe cted cost” for each group of physicians by weighting the national specialty-specific expect ed costs by the group’s specialty composition of Part B payments. That is, the specialty-adjusted expected cost for each group is the weighted average of the national specialty-specific expected cost of all the specialt ies in the group, where the weights are each specialty’s proportion of the group’s Part B payments. The Part B payments for each specialty are determined base d on the payments to each EP in the group, and each EP is identified with one specialty based on its claims.

### CMS-1600-FC 1216

Step 3 : Divide the total per capita cost by th e specialty-adjusted expected cost, and multiply this ratio by the national average per capita cost so that we can convert this ratio to a dollar amount (referred to as the “s pecialty-adjusted total per capita cost”) that can then be used in the standardized (Z-) score to determine whet her a group can be classified as high cost, low cost, or average. Below, we illustrate the three steps of the sp ecialty adjustment to the standardized score with an example. Assume for simplicity that onl y two TINs and two specialties exist: TIN 1 and TIN 2, and Specialty A and Specialty B. For this example, assume that the total per capita costs and specialty shares are as shown in Table 87. TABLE 87: Example of Calculating Speci alty-Adjusted Total Per Capita Cost: Assumptions

TIN RiskAdjusted Per Capita Cost Number of Attributed Beneficiaries Number of EPs in TIN by Specialty Type A or B Specialty Share of EPs in TIN Specialty Share of Part B Payments in TIN TIN 1 $12,000 1,500 A: 10; B: 30 A: 25%; B: 75% A: 35%; B: 65% TIN 2 $8,000 2,000 A: 21; B: 39 A: 35%; B: 65% A: 60%; B: 40%



### Step 1 : To compute the national specialty-specific expected cost for a specialty across all TINs, we first calculate the numerator, which is the product of each TIN’s total per capita cost times its weight (the number of attributed benefi ciaries times that specialty’s share of the TIN’s

EPs times the number of EPs of th at specialty in that TIN), summed across all TINs. This sum is divided by the denominator, which is the sum across all TINs of the same weights that were used in the numerator. For this example, the national specialty-specific expected cost for Specialty A is ($12,000 * 1,500 * 25%*10 + $8,000 * 2,000 * 35%*21) / (1,500 * 25%*10 + 2,000 * 35%*21) = $8,813. Similarly, the national specia lty-specific expected co st for Specialty B is

### CMS-1600-FC 1217

($12,000 * 1,500 * 75%*30 + $8,000 * 2,000 * 65%*39) / (1,500 * 75%*30 + 2,000 * 65%*39) = $9,599. National Specialty-Specific Expected Cost, by Specialty (step 1) Specialty A: $8,813 Specialty B: $9,599 Step 2 : To calculate the specialty -adjusted expected cost for each group (TIN), we would multiply the above national specialty-specifi c expected costs by each group’s proportion of specialty-specific Part B payments. For each TIN, we compute the product of the TIN’s proportion of specialty-specific Pa rt B payments, summed across all specialty types of the TIN. In our example, the specialty-adjusted expected cost for TIN 1 would be computed as 35% * $8,813 + 65% * $9,599 = $9,324. Similarly, the specialty -adjusted expected cost for TIN 2 would be 60% * $8,813 + 40% *$9,599 = $9,127. Specialty-Adjusted Expected Cost, by TIN (step 2) TIN 1: $9,324 TIN 2: $9,127 Step 3 : We divide the total per capita cost by the specialty-a djusted expected cost and multiply this ratio by the national average per capita cost, to convert this ratio to a dollar amount. Assuming the national average per capita cost is $9,714, we can compute the specialty-adjusted total per capita cost for each TIN, as shown in Table 88.

### CMS-1600-FC 1218

TABLE 88: Example of Calculating Speci alty-Adjusted Total Per Capita Cost: Calculations COLUMN A B C D

TIN Total Per Capita Cost SpecialtyAdjusted Expected Cost National Average Per Capita Cost Specialty-Adjusted Total Per Capita Cost: ((Column A / Column B) * Column C) TIN 1 $12,000 $9,324 $9,714 $12,502 TIN 2 $8,000 $9,127 $9,714 $8,514 

### The figure in the rightmost column (column D) is the specialty-adjusted total per capita cost that is used to compute a group’s standard ized (Z-) score. As can be seen, the specialtyadjusted total per capita cost for use in the standardized score is $12,502 for TIN 1 and $8,514

for TIN 2. To illustrate the impact of the specialty adjustment methodology, we examined the distribution, by specialty, of the overall specialty-adjusted total a nnual per capita cost measure based on 2011 claims for group of physicians with 1 or more eligible professionals. Please see Table 66 of the CY 2014 proposed rule (78 FR 43498 through 43499) for the results of this analysis. Under this methodology, we perform this spec ialty adjustment prior to computing the

standardized score for all six cost measures incl uded in the value-based payment modifier: the total per capita cost measure, the four total per capita cost measures for beneficiaries with specific conditions, and the MSPB measure. Th e specialty adjustment for the four conditionspecific total per capita cost measures is identica l to the total per capita cost measure that was described above. The specialty adjustment for the MSPB cost measure is analogous to that described above for the total per capita cost meas ure, except that “number of beneficiaries” is replaced with “number of episodes” and “per cap ita cost” is replaced with “per episode cost.” Thus, each cost measure will have its own set of specialty-specific expected costs.

### CMS-1600-FC 1219

We considered and tested a second met hod, “comparability peer grouping,” which constructs peer groups for each physician group practice by identifying gr oup practices with the nearest comparable specialty mix. 5 

### Under this approach, tw o group practices would be considered to have the same specialty mix if the share of physicians of each specialty is within a defined range for both group practices. Group practices that had a specialty mix more comparable to the practice’s own mix would rece ive greater weight in the peer group. Among the identified peers sharing the same specialty mi x, those with the most cases would receive the greatest weight. We stated in the proposed rule that, on ba lance, we believe that the first method, the specialty benchmarking method, is preferable to account for the specialty composition of the group of physicians when making peer group comparisons and crea ting the standardized score for the cost measures for the value-based paym ent modifier. We also stated that this methodology allows us to apply the value-based pa yment modifier to smaller size groups and solo practitioners. This met hodology creates one national benchmark for each cost measure. Moreover, all groups of physicians (regardless of size) are asse ssed against that benchmark in creating the group of physicians’ st andardized score. Although th e calculations discussed above may be very detailed, they are transparent a nd we can provide each group of physicians with

information on how its costs were benchmarked in its Quality and Resource Use Report. By contrast, the second method, comparabil ity peer grouping, would require us to develop a transparent way to define which groups of physicians are similar enough to be included in each group of physicians’ peer group. This approach also creates a different

5 For a description of this type of method, see, for example, Margaret M. Byrne, et al., Method to Develop Health Care Peer Groups for Quality and Financial Comparisons Across Hospitals. April 2009. HSR: Health Services Research 44:2, Part I: 577-592.

### CMS-1600-FC 1220

benchmark for each group of physicians, whic h may make it more difficult for groups of physicians to understand how their costs are benchmarked. Given these considerations, we proposed to use the first method, the specialty benchmarking method, to create th e standardized score for each group’s cost measures beginning with the CY 2016 value-based payment modifier . Accordingly, we proposed to amend our regulations at §414.1255 to include this policy in our cost com posite methodology. We solicited comment on our proposals, including comments on wa ys to streamline or enhance the calculation mechanics and to make the specialty adjustment s more transparent and easily understood. We

also solicited comment on the alternative me thod, the comparability peer grouping method. We proposed to identify the specialty for each EP ba sed on the specialty that is listed on the largest

share of the EP’s Part B claims. We unders tand that many physicians believe our current specialty designations may mask sub-specialist care furnished. We note that the procedures for obtaining a CMS specialty code are available at http://www.cms.gov/Medicare/ProviderEnrollment-and-Certification/Me dicareProviderSupEnroll/Taxonomy.html . The following is summary of the comments we rece ived regarding these proposals.

Comment : The majority of commenters support ed our approach to consider physician specialty in our cost benchmarking. For exampl e, one commenter sugges ted it was a significant improvement over our current methodology. Anot her commenter supported the refinement of the cost measure benchmarking methodology to reflect the full range of pract itioners. A number of commenters expressed support for CMS refining the cost measure benchmarking methodology to account for a physician’s specialty. A number of the commenters who supported th e proposal, as well as several others who neither supported nor opposed the proposal, s uggested that CMS study further the specialty

### CMS-1600-FC 1221

adjustment to determine the impacts and potential unintended consequences prior to its inclusion

so that future refinements can be made if n ecessary. Some commenters also asked that CMS continue to consider opportunities to compare phys icians based on the type of patients they are seeing. A number of commenters urged CMS to use more subspecialty designations in the approach to adequately account for subspecialties and allow fair benchmark comparisons of cost provided by specialists. Several commenters sugge sted that we assign sp ecialty designations based on a claims analysis to identify the servic es most typically provid ed by the individual (that is, the top 15 services the provider renders ba sed on submitted claims) and assign their specialty based on the care they are most frequently pr oviding. Another commenter suggested that we include an adjustment for site of service (for ex ample, nursing home or long-term care facility). Several commenters expressed concern that the CMS’ proposed approach to specialty adjustment could result in a “high cost” desi gnation for about 15 percen t of some specialties (geriatricians, geriatric psychiatrists, neurosurgeons, medi cal and surgical oncologists), which could suggest a problem in the methodology. While most commenters supported the sp ecialty adjustment approach over the comparability peer grouping approach, several commenters preferred the comparability peer grouping approach. One commenter indicated that they did not have sufficient information on

the criteria that CMS would use to determine comparable peer groups if the approach were implemented. Although more commenters who e xpressed a preference indicated that the specialty adjustment approach was more tran sparent, several commenters stated that the comparability peer grouping method would likely ach ieve greater transparency of performance, although the specialty adjustment method might be simpler to calculate. The same commenters recommended further study by CMS of the comparability peer grouping approach.

### CMS-1600-FC 1222

Response : We agree that the proposal is a si gnificant improvement over our current methodology. We believe that the credibility of the quality-tiering approach depends on accuratecomparisons among physicians to determine those physicians that are members of high- and lowcost groups. We proposed this method to adju st our benchmarking approach for all cost measures to create more comparable peer groups through developing a benchmark for each group based on the specialty composition of the gr oup. We believe that this proposal improves upon our cost benchmark such that it would be appropriate once we apply the value-based payment modifier to smaller gr oups and solo practitioners. We also believe that the specialty adjust ment approach is adaptable to comparing physicians in solo practices, which is important because in 2017 we are required to apply the value-based payment modifier to all physicians and groups of physicians. Although we received a number of comments from sub-specialists about the lack of granularity among the available CMS physician specialties, we believe this appr oach is better than relying on group size alone. We also will explore ways to explain to sub-sp ecialists the processes that we have in place to obtain a new or keep their CMS specialty designati on current, and we encour age all physicians to periodically review and keep their Medicare enrollment information current including specialty designations. We agree that an adjustment for site of se rvice (for example, nur sing home or long-term care facility) is worthwhile to consider, and will take this comment into account as a potential refinement for further exploration. Regarding the concern that our proposed approa ch to specialty adjustment could result in a “high cost” designation for about 15 percent of some specialists , we would like to clarify the data on Table 66 of the proposed rule (78 FR 43498 through 43499). Table 66 provides the

### CMS-1600-FC 1223

percentage of physicians practici ng in groups with one or more e ligible professionals with at

least 20 beneficiaries and does not re present all physicians w ithin that specialty. Therefore, it is incorrect to state, for example, that Table 66 (Percentage of P hysician Practicing in Groups with 1 or more Eligible Professionals with at Least 20 Beneficiaries, Classified by Cost), indicates that 14.9 percent of neurosurgeons would be clas sified as “high cost.” Rather, 14.9 percent of neurosurgeons practicing in groups with 1 or mo re eligible professiona ls with at least 20 beneficiaries attributed to the practice would be classified as “high cost.” We believe that the comparability pe er group method would require too many assumptions to be a practical alternative to consid er implementing in the near term. As a result, we believe that the comparabil ity peer group method option would be less transparent than the specialty adjustment method. Although the specialty adjustment method process is somewhat computationally involved, the calcul ations are straightforward, and we believe that the method is transparent. We believe that it is not necessary to delay implementing the specialty adjustment method, but we do agree that it is important to mo nitor the impacts of th e specialty adjustment method on physician groups as the method is implemented starting with the 2016 value-based payment modifier.

After consideration of the co mments received and the reas ons given previously, we are finalizing our proposal to use the specialty adjustment method to create the standardized score for each group’s cost measures beginning with the CY 2016 value-based payment modifier. That is, we are refining our current peer gr oup methodology to account for specialty mix using the specialty adjustment method. We also are fina lizing our proposal to am end our regulations at §414.1255 to include this policy in our cost composite methodology. Additionally, we are

### CMS-1600-FC 1224

finalizing our proposal to identify the specialty for each EP based on the specialty that is listed on the largest share of the EP’s Part B claims. 5. Physician Feedback Program Section 1848(n) of the Act requires us to pr ovide confidential repo rts to physicians that measure the resources involved in furnishing care to Medicare FFS beneficiaries. Section 1848(n)(1)(A)(iii) of the Act also authorizes us to include in formation on the quality of care

furnished to Medicare FFS bene ficiaries. In the CY 2014 PFS proposed rule (78 FR 43500) we described the 2011 group and individual QRURs, which were based on CY 2011 data that we made available to certain physicians and gr oups of physicians. These reports provided physicians and groups of physicians with comp arative performance data (both quality and resource use) that can be used to improve qua lity and coordinate care furnished to Medicare

FFS beneficiaries. We also noted that in May 2013, we provided supplemental QRURs to group report recipients that featured episode-b ased costs for care of pneumonia and several

acute and chronic cardiac conditions. We deri ved these episode-based costs using the newly developed CMS Episode Grouper software requi red by section 1848(n)(9)(ii) of the Act. a. CY 2012 Group Quality and Resource Us e Reports Based on CY 2012 Data and

Disseminated in CY 2013. On September 16, 2013, we made available CY 2012 QRURs to 6,779 physician groups

nationwide with 25 or more EPs. These reports covered approximately 400,000 physicians practicing in large medical groups. These reports were available eight and one-half months from the close of the performance period (December 31, 2012) and 5 months from the close of the quality data submission period (March 31, 2013) – tim eframes that are generally consistent with reporting programs in the commercial sector. Not only did these reports provide comparative

### CMS-1600-FC 1225

quality of care and cost information like in pr evious years, but they also previewed how the groups of physicians might fare under the value- based payment modifier. Thus, these reports were a “first look” at how the value-based paym ent modifier could affect their payment in the future. The QRURs provided groups of 100 or more EPs with quality-tiering information on 2012 data that they could use to decide whether to elect to be assessed un der the quality-tiering approach that we adopted for the value-based payment modifier that will be applied in 2015, based on 2013 performance. Additionally, and in response to feedback we received from prior year reci pients of the QRURs, the CY 2012 QRURs contained detailed beneficiary-specific data on each group’s

attributed beneficiaries and their hospitalizations , and the group’s associated eligible professionals. Complementing the CY 2012 QRURs are three downloadable drill down tables that provide information on each beneficiary attributed to the group and each eligible professional billing under the group ’s Taxpayer Identifica tion Number (TIN). We have received very positive feedback from repor t recipients and expect to enha nce the information we provide in future years. Of the 6,779 physician groups nationwide with 25 or more EPs, 3,876 groups received full QRUR reports and 2,903 groups received an a bbreviated report since th ey did not have any

beneficiaries attributed to them or did not have at least 20 eligib le cases for any quality or cost measure. These 2,903 groups had insufficien t data on which to compute meaningful performance measures. Given the policies that we have adopted in this final rule with comment period, we anticipate that as long as a group of physicians particip ates in the Physician Quality Reporting System (PQRS) in 2014 and meets the criteria to avoid the 2016 PQRS payment adjustment such that group is in Category 1 (s ee discussion above in section III.K.4.b.), we will

### CMS-1600-FC 1226

be able to produce a complete QRUR, including their quality-tiering desi gnation, in CY 2014 for most groups. Highlights of major findings of thes e CY 2012 reports are as follows:

● Of the 3,876 groups for whom the quality or cost composite could be calculated based on 2012 data, over 80 percent of the groups (80.7 per cent) are in the averag e quality and average cost tiers under the quality-tiering met hodology, and thus, would not receive a payment adjustment. Approximately 8 percent of groups are in tiers that would receive an upward adjustment, and slightly less th an 11 percent of groups are in tiers that would receive a downward adjustment. Among the groups eligible for an upward adjustment, 11 percent would receive an additional 1.0 percent incentive payment due to treating high-risk beneficiaries. Although we expect the results to change as physician groups understa nd our methodologies and seek to maximize their upward payment adjust ment under the value-based payment modifier, these results are consistent with our approach to gradually implement the value-based payment modifier (see 2. Governing Principles fo r Physician Value-Based Payment Modifier Implementation), that is, to focus on adjusting payment for those groups that are outliers (both high and low performers).

● Groups with high quality scores performe d better than groups with average and low quality scores consistently across each of the quality domains (or groupings of quality measures) as well as across the three quali ty outcomes measures; they also tended to have lower average cost composite scores.

● Beneficiaries that we attributed to a group of physicia ns received an average of five primary care services in 2012 of which, on aver age, 64.3 percent were provided by the group to which the beneficiary was attributed. These re sults suggest that our attribution approach

### CMS-1600-FC 1227

attributes beneficiaries to those groups of physicians that deliver the majority of a beneficiary’s care and are well positioned to ove rsee the beneficiaries’ care.

● Reliability among the quality measures wa s generally strong, w ith the self-reported PQRS measures having the greatest average relia bility. Average reliabilities for all PQRS measures were more than 0.80, indicating high relia bility. We note that statistical reliability scores are represented on a continuum from zero and one, with scores closer to zero indicating lower reliability while scores closer to one indicate higher reliability. While there is no universally agreed upon minimum reliability threshold, reliability scores in the 0.40-0.70 range are often considered moderate and scores greater than 0.70 are considered high. In addition to the PQRS measures, we computed 14 quality indicators from data reported in Medicare administrative claims. The average reliability of the claims-based quality indicators was lower than for the PQRS quality measures but was sti ll quite high with 8 of the 14 measures having average reliabilities above 0.70.

● The 2012 QRURs also reported on thr ee administrative claims-based outcome measures. The QRURs contained each group practic e’s performance on measures of potentially avoidable hospitalizations for ambulatory care sensitive conditions (ACSCs). These Medicare

claims-based measures were derived from Preven tion Quality Indicators (PQIs) developed by the Agency for Healthcare Research and Quality (AHRQ). We reported on potentially avoidable hospitalizations for two composite measures of hospital admissions for acute and chronic ACSCs. The average reliability for both AC SC composite measures across all groups was higher than 0.70. CMS also reported on a medical group practice-spec ific all-cause 30-day rate of acute care hospital readmissions for beneficiarie s discharged from an acute care or critical access hospital. Average reliability among the subset of groups of 100+ EPs was 0.48. We

### CMS-1600-FC 1228

anticipate the reliability of this measure to increase as gr oups of physicians begin to focus on reducing unplanned readmissions.

● The QRURs include five cost-of-care measures derived from 2012 administrative claims data: total per capita costs and per cap ita costs for beneficiaries with four common chronic conditions: diabetes; heart failure; COPD; and CAD. The per capita (per beneficiary)

cost measure assesses health care services for al l Medicare FFS attributed beneficiaries and for

those with chronic conditions. The measure incl udes all Medicare Part A and Part B costs during a calendar year and is price- standardized and ri sk-adjusted to account for any potential differences in costs among providers that resu lt from circumstances beyond the physician’s control. The risk adjustment process redu ced the overall average pe r capita costs from $12,815 to $10,788 and compressed the range of groups’ total per capita costs by 83 percent. Under our attribution rule, beneficiaries are attributed on the basis of the plurality of primary care services, to those medical group practices w ith the greatest potenti al to influence the quality and cost of

care delivered to Medicare FFS beneficiaries. All group practices with 25 or more EPs achieved an average reliability score of 0.94 for the total per capita cost measure. For all groups, average

reliabilities for the condition- specific cost measures ranged from 0.82 to 0.84. For larger groups with 100+ EPs, average reliability was higher fo r all beneficiaries (0.98), as well as for the condition-specific cost measures (0.94 for all measures). We anticipate publicly releasing a full e xperience report of the CY 2012 QRURs that will include how quality-tiering w ould apply to groups of physicians to ensure stakeholders understand the methodologies of the value-base d payment modifier. The report will be available on the Physician Feedback Program website. b. Episode Costs and the Supplemental QRURs

### CMS-1600-FC 1229

Section 1848(n)(9)(A)(ii ) of the Act, as added by secti on 3003 of the Affordable Care Act, requires CMS to develop a Medicare epis ode grouper by January 1, 2012, and to include episode-based costs in the QRURs. An episode of care consists of medical and/or procedural

services that address a specific medical condition or procedur e that are delivered to a patient within a defined time period and are captured by cl aims data. An episode grouper is software that organizes administrative cl aims data into episodes. We have developed a CMS prototype episode grouper that classifies episodes into three categories: chronic; acute; and procedural. In the CY 2014 PFS Proposed Rule (78 FR 43502) we described the supplemental QRURs we made av ailable to 54 large gro up practices in June 2013 to illustrate how the CMS Episode Grouper work s and to illustrate the general approach to classifying episodes of care into these thre e categories. The Supplemental QRURs included episode-based costs for five clin ical conditions (pneumonia, acute myocardial infarction (AMI), coronary artery disease, percutaneous coronary intervention (PCI), and coronary artery bypass graft (CABG)), which also were broken into 12 episode sub-types to account for various underlying clinical factors. We chose these episode types to gain experience with the prototype methodology of the CMS episode grouper in acute, chronic and procedural conditions. We applied different attribution rules fo r each episode type (chronic, acute, or procedural) and whether the episode included a hospitalization. We be lieve that it is critical to attribute an episode to the group of physicians that is in the best position to oversee the quality of

care furnished and the resources used to furnish th at care. For chronic episodes, attribution was based on outpatient E&M visits, be cause these conditions are best managed in an outpatient setting. For acute inpatient-based episodes, attribution was based on Part B Physician Fee Schedule allowed amounts during th e inpatient stay or percent of inpatient E&M visits; for

### CMS-1600-FC 1230

outpatient-based acute episodes, attribution was based on E&M visits during the episode. For procedural episodes, attribution is made to the group that includes the performing surgeon. For chronic and acute episodes, attr ibution required at least 35 per cent of total allowed amounts or E&M visits, as applicable to the episode type. Episodes may be attributed to more than one group, although 85 percent of all ep isodes of any type were attri buted to exactly one of the 54 medical group practices. We also used a slightly different risk adju stment methodology to adjust the costs for the underlying risk factors for the beneficiaries with these episodes as comp ared to the total per capita cost measures that we have used in the CY 2012 QRURs. The CMS Episode Grouper used to generate the 2011 episode data adjusted costs for health and treatment history in the 6 months prior to the beginning of the episode. More specific risk adjusters incl ude demographic factors (age, gender, and enrollment status), he alth status indicators (for example, medical condition categories from HCC mode l), and procedure indicators. We are continuing to examine ways to refine this approach as we devel op further episode costs for additional clinical

conditions. The episodes we included in th e reports had a high statisti cal reliability and showed a significant amount of variation across the groups and within the groups. From a reliability perspective, episodes had high or moderate reliability with si x having a reliability of risk adjusted cost greater than 0.7 (range 0.78 for all AMI to 0.9 for coronary artery disease without AMI) and six between 0.5 and 0.7 (range 0.56 for PCI without AMI to 0.69 for AMI with PCI).

. There also was variation among the groups’ mean episode costs compared to the national mean. For four of the five conditions, about half of the groups had a mean episode cost that was above the national episode mean, while about ha lf were below. The exception was coronary

### CMS-1600-FC 1231

artery disease, for which only about 20 percent of the groups had mean episode costs below the cost of the national mean. Primary cost driv ers varied by episode s ubtype (for example, coronary artery disease with or without myocardial infarction), and depended on whether or not the episode included inpatient hospital stays and post-acute care such as for skilled nursing

facilities and rehabilitati on facilities. As noted above, risk adjustment was used to account for variations in resource use beyond the medical group’s control. We plan to further develop these episode reports and to include not only additional episodes, but to make this information availa ble to a wider set of medical group practices.

Additional clinical cond itions under considerat ion for future QRURs include episode costs related to congestive heart failure, cardiac arrhyt hmias, hip fracture, osteoarthritis, cataract, glaucoma, chronic obstructive lung disease, and resp iratory failure. In addition, we will begin to marry these measures of resource use with clinic al quality measures included in the Physician Quality Reporting System, because resource use ma kes most sense in context of the quality of

care furnished. We have worked with stakeholders and speci alty societies to gain input for the next iteration of the CMS Episode Grouper. We r eceived input to examine episode attribution, handling of transfers, relook at risk adjustme nt, and increased drill down capacity. The CMS Episode Grouper will continue to evolve over the next few years as more experience is gained. More information about the Supplemental QRURs and a summary slide deck of findings on episode costs for medical groups eligible to receive the 2011 supplemental QRURs can be found

at http://www.cms.gov/Medicare/M edicare-Fee-for-ServicePayment/PhysicianFeedbackProgram/Episode-C osts-and-Medicare-Episode-Grouper.html. c. Future Plans for the Physician Feedback Reports

### CMS-1600-FC 1232

We will continue to develop and refine the annual QRURs in an iterative manner. As we have done in previous years, we will seek to further improve the reports by welcoming suggestions from recipients, specialty societies, professional associations, and others. We have worked with several specialty so cieties to develop episode costs or other cost or utilization

metrics to include in the annual QRURs. We believe these effo rts could be productive as we use the QRURs to not only describe how the valu e-based payment modifier would apply, but in addition to provide groups with utilization and other statistics that can be used for quality improvement and care coordination. The following is a summary of the comment s we received about the QRURs. We appreciate commenters’ suggestions, but because we did not make any proposals relating to the QRURs, these comments were beyond the scope of the proposed rule. We will consider them as we further implement the Physician Feedback Program.

Comment: We received some comments in respon se to our description of updates to the QRUR program. Many commenters were very fa vorable about CMS’ work with the physician community to develop the reports an d asked that we continue to work with them to refine them. One commenter stated that, “CMS has taken large strides to improve the clarity and usability of the QRUR reports to present cost and quality in formation in a meaningful and clear way.” The commenter also suggested that CMS reconvene the stakeholder workgroup to continue to enhance the feedback reports fo r 2014 and future years. Some commenters made suggestions about how to improve the reports. One commente r suggested that CMS reduce the length of the report, tailor reports to each specialty by highlig hting the measures/conditi ons of the particular specialist receiving the report, in clude more details on the physic ian’s patient population, provide recommendations on action items, and accurately id entify other providers whose data may have

### CMS-1600-FC 1233

been used in developing the repo rt. Another commenter asked CM S to continue to improve the timeliness and frequency of the reports. One commenter suggested that CMS should report data

at the individual NPI level and ro ll the data up to the TIN level. Some comments suggested that CMS should give providers an opport unity to view their data before they were penalized so that they would have an opportunity to change thei r behavior. One commenter suggested that CMS should offer providers corrective action plans so that physicians could improve their performance before being impacted by the value based modifier . Some commenters st ated that although they realized the statute requires CM S to roll out the value-based modifier to all physicians by January 1, 2017, they were concerned about the aggressive timetable for implementation and noted that providers were being imp acted by several programs at once. Response : We appreciate the commenters’ respons es to our description of the QRUR program and their suggestions for how to improv e it. We will take these suggestions into consideration as we further implemen t the Physician Feedback Program. We also welcome feedback about the recently released reports over the next few months

and have several activities scheduled to allow physicians to give us their additional input. In the late summer of 2014, we plan to disseminat e the QRURs based on CY 2013 data to all physicians (that is, TINs of any size) even though groups of physicians with fewer than 100 eligible professionals will not be subject to the value-based payment modifier in CY 2015. These reports will contain performance on the quality and cost measures used to score the composites and additional information to help physicians coordinate care and improve the quality of care furnished. The reports will be based on the value-based payment modifier policies that we are finalizing in this rule that wi ll take effect January 1, 2014 and that will affect physician payment starting January 1, 2016. Groups of physicians will, therefore, have an

### CMS-1600-FC 1234

opportunity to determine how the policies adopted in this final rule with comment period will apply to them. After the reports are released we will again solicit feedback from physicians and continue to work with our part ners to improve them. We note that physicians will have some time to determine the impact of our revised policie s and revise their practices accordingly before the new policies impact them. We will study the r ecommendations submitted in response to this proposed rule and any later sugges tions we receive and make plan s to implement those that are

feasible. We look forward to continue worki ng with the physician community to improve the QRURs.

### CMS-1600-FC 1235

L. Updating Existing Standards for E-Prescribing under Medicare Part D 1. Background a. Legislative History Section 101 of the Medicare Prescription Dr ug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) amended title XV III of the Act to establish a voluntary prescription drug benefit program at section 1860D-4(e) of the Ac t. Among other things, these provisions required the adoption of Part D e-prescribing standard s. Prescription Drug Plan (PDP) sponsors and Medicare Advantage (MA) organizations offering Medicare AdvantagePrescription Drug Plans (MA-PD) ar e required to establish electron ic prescription drug programs that comply with the e-prescribing standards that are adopted under this authority. There is no requirement that prescribers or dispensers impl ement e-prescribing. However, prescribers and dispensers who electronically tr ansmit prescription and certain other information for covered drugs prescribed for Medicare Part D eligible beneficiaries, directly or through an intermediary, are required to comply with any applicable standards that are in effect. 

### For a further discussion of the statutory basis for this final rule with comment period and the statutory requirements at section 1860D-4(e ) of the Act, please refer to section I. (Background) of the E-Prescrib ing and the Prescription Drug Program proposed rule, published February 4, 2005 (70 FR 6256). b. Regulatory History (1) Foundation and Final Standards We utilized several rounds of rulemaking to adopt standards for the e-prescribing program. Its first rule, which was published on November 7, 2005 (70 FR 67568), adopted three

standards that were collectivel y referred to as the “foundation” standards. We issued a subsequent rule on April 7, 2008 (73 FR 18918) th at adopted additional standards which are

### CMS-1600-FC 1236

referred to as “final” standards. One of th ese standards, the NCPDP Formulary and Benefit Standard, Implementation Guide, Version 1, Releas e 0 (Version 1.0, hereafter referred to as the NCPDP Formulary and Benefit 1.0) was a subject of the CY 2013 PFS final rule with comment period (77 FR 68892 at 69329) and is the subject of this final rule with comment period. Please

see the “Initial Standards Versus Final Standa rds” discussion at 70 FR 67568 in the November 7,

2005 rule for a more detailed discussion a bout “foundation” and “final” standards. (2) Updating e-Pres cribing Standards Transaction standards are pe riodically updated to take new knowledge, technology and

other considerations into account. As CMS adopted specific versions of the standards when it adopted the foundation and final e-pr escribing standards, there was a need to establish processes by which the standards could be updated or replaced over time to ensure that the standards did not hold back progress in the industry. CMS di scussed these processes in its November 7, 2005 final rule (70 FR 67579). The discussion noted that the rulemaking proce ss will generally be used to retire, replace or adopt a new e-prescribing st andard, but it also provided for a simplified “updating process” when a standard could be updated with a newe r “backward-compatible” ve rsion of the adopted

standard. In instances in which the user of th e later version can accommodate users of the earlier version of the adopted standard without m odification, it noted that notice and comment rulemaking could be waived, in which case the us e of either the new or old version of the adopted standard would be considered compliant upon the effective date of the newer version’s incorporation by re ference in the Federal Register

. (3) The NCPDP Formulary and Benefit Standard in the Part D e-Prescribing Regulations

### CMS-1600-FC 1237

The backward compatibility concept has b een used extensively to update the NCPDP

SCRIPT standard in the Part D e-prescribing program, but it has not yet been used to update the adopted NCPDP Formulary and Benefit Sta ndard. We proposed to update the NCPDP Formulary and Benefit 1.0 standard for the firs t time in the CY 2013 PFS proposed rule (77 FR 44722), but we did not ultimately finalize thos e proposals. Specifically, we proposed to recognize NCPDP Formulary and Benefit Standard 3.0 as a backward compatible version of NCPDP Formulary and Benefits 1.0 effective 60 days from the public ation of the final rule, and sought comment on when we should retire NCPDP Formulary and Benefits 1.0 as well as when we should adopt NCPDP Formul ary and Benefits 3.0 as the o fficial Part D e-prescribing standard As was noted in that rule, while re cognition of backward compatible versions can be

done in an interim final rule in which we wa ive notice and comment rulemaking, other Part D e-prescribing proposals that we re being made at that time required full notice and comment rulemaking, so, as we did not wish to publish two e-prescribing rules contemporaneously, we elected to forgo our usual us e of our simplified updating proc ess for backward compatible standards (in which we waive notice and comment rulemaking and go straight to final) in favor of putting all of the pr oposals through full notic e and comment rulemaking. 2. Proposals a. Proposed backward compatible standards

As was discussed in the CY 2013 PFS final rule with comment period (77 FR 68892), we were persuaded by commenters to refrain from re tiring Formulary and Benefit Standard 1.0 until NCPDP ceased supporting it on July 1, 2014. As further noted in that rule, we believed it best to delay implementing any of our Formulary and Be nefits proposals, incl uding recognitions of NCPDP Formulary and Benefit 3.0 as a backward compatible standard, until closer to that

### CMS-1600-FC 1238

July 1, 2014 date. Our actions at that time were based on a belief that an extended period of use

of either 3.0 or 1.0 would be ill-advised. Having come within roughly a year of the anticipated date upon which NCPDP will cease supporting NCPDP Formulary and Be nefit 1.0, we believed that it was now appropriate to repropose the recognition of NCPDP Formulary and Benefits 3.0 as a backward compatible version of Formulary and Benefits 1.0 effective 60 days after publication of a final rule until June 30, 2014, and, as discussed below, we also proposed the retirementof NCPDP Formulary and Benefits 1.0, effective July 1, 2014, and th e adoption of NCPDP Formulary and Benefits 3.0 as the official Part D e-prescrib ing standard effec tive July 1, 2014. Also, as was seen in our prior proposal to recognize backward compatibility using full notice and comment in place of the backward compatible methodology, we also proposed to require users of 3.0 to support users who are st ill using NCPDP Formulary and Benefit 1.0 until such time as that version is officially retire d as a Part D e-prescrib ing standard and NCPDP Formulary and Benefit 3.0 is adopted as the official Part D e-pr escribing standard. 2. Proposed Retirement of NCPDP Formulary a nd Benefit Standard 1.0 and adoption of NCPDP Formulary and Benefit Standard 3.0 As noted in the CY 2013 PFS proposed rule , the NCPDP Formulary and Benefits standard provides a uniform means for pharmacy benefit payers (including health plans and PBMs) to communicate a range of formulary and be nefit information to prescribers via point-ofcare (POC) systems. These include:

● General formulary data (for exampl e, therapeutic classes and subclasses);

● Formulary status of individual drugs (that is, which drugs are covered);

### CMS-1600-FC 1239

● Preferred alternatives (including any covera ge restrictions, such as quantity limits and need for prior authorization); and

● Copayment (the copayments for one drug option versus another). Also as noted in that proposed rule, st andards are updated over time to take industry

feedback and new and modified business needs into account. See the CY 2013 PFS proposed rule (77 FR 45023-45024) for a full discussion of th e changes to that were made to the NCPDP Formulary and Benefit 1.0 as it was updated to the NCPDP Formulary and Benefit 3.0. As noted above, having come within roughly a year of the anticipated date upon which NCPDP will cease supporting NCPDP Formulary a nd Benefit 1.0, we believed that it was now appropriate to re-propose the retirement of NCPDP Formulary and Benefits 1.0, effective June 30, 2014, and also proposed the adoption of NCPDP Formulary and Benefits 3.0 as the official Part D e-prescribing standa rd, effective July 1, 2014. To effectuate these proposals, we proposed to revise §423.160(b)(5). We proposed to place the existing material in a new paragraph (b)(5)(i), which would provide the official formulary and benefit standard for Part D e- prescribing until June 30, 2014. We then proposed to create a second new paragr aph ((b)(5)(ii)) to recognize NCPD P Formulary and Benefit 3.0. as a backward compatible version of the official Part D e-prescribing sta ndard (NCPDP Formulary and Benefit 1.0), effective [OFR - insert date 60 days after publication of the final rule] through June 30, 2014. Furthermore, we proposed to create a third new para graph ((b)(5)(iii)) to reflect the retirement of NCPDP Formulary and Benefit 1.0 and th e adoption of NCPDP Formulary and Benefit 3.0 as the official Part D e-prescribing standard, effective July 1, 2014. Finally, we proposed to make conforming change s to §423.160(b)(1). We solicited comment on these proposals.

### CMS-1600-FC 1240

The following is a summary of the comments we received regarding our proposal to recognize NCPDP Formulary and Benefit Standard 3.0 as a backward compatible version of the NCPDP Formulary and Benefit Standard 1.0, the proposed retirement of NCPDP Formulary and Benefit Standard 1.0 and the proposed adoption of NCPDP Formulary and Benefit Standard 3.0.

Comment : Commenters generally supported our pr oposal to adopt the newest version of the NCPDP Formulary and Benefit Standard 3.0 as a backward compatible version of the adopted NCPDP Formulary and Benefit 1.0 (60 days after the publica tion of the final rule), and

the retirement of Version 1.0 as an official Part D e-prescrib ing standard, effective June 30,

2014. Response : We appreciate the favorable feedback that we received on this proposal and are in agreement with the commenters who responded. We received a total of 9 comments on our proposal as it related to the effective date of adopting Formulary and Benefit standard 3.0 on Ju ly 1, 2014 and the retirement of Formulary and Benefit Standard 1.0 on June, 30 2014 as an official Part D e-pres cribing standard.

Comment : Some commenters agreed with our proposal stating that these types of updates are routine and reflect improvements. Response : We appreciate the feedback we rece ived on the proposed timeline to retire Formulary and Benefit Standard 1.0 on June, 30 2014 and to finalize adoption of the Formulary

and Benefit standard 3.0 as the official Part D e-prescribing formulary and benefits standard on July 1, 2014. .

Comment : One commenter appreciated our decision in the CY 2013 Medicare Physicians Fee Schedule to delay retiring NCPD P Formulary and benefits Standard 1.0 and adopting the NCPDP Formulary a nd Benefits 3.0. They are co ncerned, however, with our

### CMS-1600-FC 1241

proposal to go forward with the proposed e ffective dates for the adoption of the NCPDP Formulary and Benefits Standard 3.0 and the retirement of Version 1.0 on July 1, 2014. The

commenter stated that the current deadline for ICD-10 conversion is October 1, 2014 and many

of their resources are devoted to the ICD-10 conversion coding as well as additional systems requirements that they assert they will need to make due to the implementation of the health insurance exchanges on January 1, 2014. They ur ged CMS to consider delaying the adoption of the NCPDP Formulary and Benefits 3.0 update un til early 2015. They stated that this would provide stakeholders with sufficient time to be able to ensure adequate time to address these issues that are coming online in 2014. Response : We appreciate the comment, but we di sagree with the commenter’s concerns about the conversion to ICD-10 on October 1, 20 14. On October 1, 2014, the ICD-9 code sets used to report medical diagnoses and inpatient procedures will be replaced by ICD-10 code sets. The transition to ICD-10 is required for everyon e subject to the Health Insurance Portability Accountability Act (HIPAA). Industry has had 3 y ears to prepare for this new requirement and should have already started prepar ing for the conversion to ICD-10, so we do not believe that the conversion to the NCPDP Formulary and Benefi t Standard 3.0 will present an undue added

burden. Furthermore, we do not agree with commenter’s assertion that the implementation of the health care exchanges on January 1, 2014 will im pose burdens that would affect an entity’s ability to implement the NCPDP Formular y and Benefit Standard 3.0 on July 1, 2014. Furthermore, we would note that the health care exchanges actually went live on October 1, 2013, with coverage for those who enroll begi nning as early as January 1, 2014. Any system changes that may be needed w ill therefore have to have been made by October 1, 2013, or

### CMS-1600-FC 1242

January 1, 2014, depending on what systems the co mmenter may have been referencing. As such, we do not see how the implementation of th e health care exchanges would have any impact on the proposed implementation date for the NCPDP Formulary and Benefit Standard 3.0 on July 1, 2014.

Comment : Two commenters recommended that we delay the proposed June 30, 2014 and July 1, 2014 effective dates 12 months. One co mmenter stated that 7 months is insufficient time for safe and efficient development and implem entation. They asserted that, if the proposed rule goes into effect, the propsed dates would leave EHR developers and EHR users approximately 7 months to do all of the following:

● Complete development to support for the new standard.

● Test the configuration requi red for the new standard.

● Move this configuration into production. Another commenter urged CMS to consid er an 18-month timeframe between the effective date of this final rule and the comp liance date for those subject to the rule. The

commenter stated that 18 months would allow EHR developers and healthcare organizations to include the upgrade with other work already in progress for programs such as Meaningful Use

and the ICD-10 transition. The commenter recommende d the retirement of the use of the current NCPDP Formulary and Benefit 1.0 standard June 30, 2015 and the adoption of NCPDP Formulary and Benefit 3.0 as the official Part D e-prescribing formulary a nd benefits standard on July 1, 2015.

Another commenter recommende d that entities be allowed to use NCPDP Formulary Benefit Version 1.0 or Version 3.0 during a tran sition period that would end June 30, 2015, and

### CMS-1600-FC 1243

that the NCPDP Formulary and Benefit 3.0 should become the official Part D e-prescribing formulary and benefits standa rd effective July 1, 2015. Response : We appreciate the comments but do not believe that there is a compelling reason to allow use of NCPDP Formulary Bene fit Version 1.0 or Version 3.0 through June 30, 2015, or to wait to make NCPDP Formulary and Be nefit 3.0 the official Part D standard until July 1, 2015. As we have stated in the past, we do not think it is advisable to have extended periods in which either an adopted standard or a backward compa tible version of that standard may be used. We believe that allowing the extended use of Version 3.0 as a backward compatible version of Version 1.0 would create confusion. We understand that our regulations should impose the minimum burden possible on the industry; we therefore re-evalu ated our initial timeline proposal in light of recommendations from commenters. We concluded that a July 1, 2014 effective date may be an aggressive timeline for the implementation of the updated NC PDP Formulary and Benefits 3.0 standard, and

that some of the commenters have made valid ar guments in regards to moving the effective dates back from what we originally proposed.

Commenters have convinced us that if we were to finalize the original timelines as proposed, the industry may not have time to ensu re that all of the changes, testing, and implementation activities for the move to Versio n 3.0 will be completed in time. At the same time, however, we believe that th e suggested 18 month delay in e ffective date is too long. We believe a suitable compromise would be to dela y the effective date of our proposals to retire Version 1.0 and to adopt Version 3.0 as the offici al Part D e-prescribing standard by moving the originally anticipated effective da te of this final rule to early 2015. As such, we will retire the Version 1.0 effective February 28, 2015, and a dopt Version 3.0 as the official Part D e-

### CMS-1600-FC 1244

prescribing standard effective March 1, 2015. Fu rthermore, Version 3.0 will be recognized as a backward compatible version of the adopted Version 1.0 from [ OFR - insert date 60 days from publication in Federal Register ] through February 28, 2015.

Comment : We received a comment from NCPDP that asked for clarification of our statement in the proposed rule regarding the anticipated date upon which NCPDP would cease supporting NCPDP Formulary and Bene fit 1.0. NCPDP stated that they do not intend to cease to support NCPDP Formulary and Benefit Standard Ve rsion 1.0, meaning that it will always be

included as a a version in the li sting of NCPDP publications. Th ey acknowledged that versions may be retired over time as the industry ceases active use of them, but, as in this case, regulations would drive which version would be the appropriate version to be used. Response : We appreciate the comment from NC PDP clarifying that they will keep NCPDP Formulary and Benefits 1.0 in its list of publications av ailable to its membership. As a result of the comments, we believe that some of the commenters have made valid arguments in regards to moving the effective date s back from what we originally proposed. We believe a suitable compromise would be to dela y the effective date of our proposals to retire Version 1.0 on February 28, 2015 and to adopt Versi on 3.0 as the official Part D e-prescribing standard on March 1, 2015. This would allow industry adequate time to implement the necessary changes and testing needed to implement. That means that the retirement of Version 1.0 will be effective February 28, 2015, and the adoption of Ve rsion 3.0 as the official Part D e-prescribing standard will be effective March 1, 2015. We are therefore finalizing recognition of the NCPDP Form ulary and Benefits Standard 3.0 as a backward compatible version of NCPDP Fo rmulary and Benefits Standard 1.0 as of the effective date of this final rule with comment period effective [ OFR - insert date 60 days after

### CMS-1600-FC 1245

publication in the Federal Register ], the retireent of NCPDP Formulary and Benefits Standard Version 1.0 effective February 28, 2015 and the adoption of NCPDP Form ulary and Benefits

Standard Version 3.0 as the offici al Part D e-Prescribing Standa rd effective March 1, 2015. To effectuate this, we are revisi ng §423.160(b)(5) to redesi gnate the current (b )(5) as (b)(5)(i), which will cover prior to [ OFR—Insert date 59 days aft er publication in the Federal Register ], and adding a new (b)(5)(ii) (which wi ll cover [OFR—Insert date 60 days after publication in the Federal Register ] until February 28, 2015) and (b )(5)(iii) (whi ch will cover March 1, 2015 and beyond). Section (b)(5)(ii) will be applicable to the period in which Version 3.0. will be recognized as a backward compatib le version of Version 1.0, during which time Version 1.0 will remain the official Part D e-pr escribing standard. Section 423.160(b)(5)(iii) will be applicable to the period in which Version 3.0 is the official Part D e-prescribing standard. We will also amend the incorporation by reference in the Part D e-prescribing regulations by adding a reference to the NCPDP Formulary and Benefit Standard 3.0 at §423.160(c)(1)(vi). Finally, we will make conforming changes to §423.160(b)(1) to reflect the changes to §423.160(b)(5).

### CMS-1600-FC 1246

M. Discussion of Budget Neutrality for the Chiropractic Services Demonstration Section 651 of MMA requires the Secretary to conduct a demonstration for up to 2 years to evaluate the feasibility and advisability of expanding coverage for chiropractic services under Medicare. Current Medicare coverage for chiropr actic services is limited to treatment by means of manual manipulation of the sp ine to correct a subluxation desc ribed in section 1861(r)(5) of the Act provided such treatment is legal in the state or jurisdiction where performed. The demonstration expanded Medicare coverage to include: “(A) care for neuromusculoskeletal conditions typical among eligible beneficiaries; and (B) diagnos tic and other services that a chiropractor is legally authorized to perform by the state or juri sdiction in which such treatment is provided.” The demonstration was conducted in four geographically diverse sites, two rural and two urban regions, with each type including a Health Professional Shortage Area (HPSA).

The two urban sites were 26 counties in Illin ois and Scott County, Iowa, and 17 counties in Virginia. The two rural sites were the States of Maine and New Mexico. The demonstration, which ended on March 31, 2007, was required to be budget neutral as sect ion 651(f)(1)(B) of MMA mandates the Secretary to ensure that “t he aggregate payments made by the Secretary under the Medicare program do not exceed the am ount which the Secretary would have paid under the Medicare program if the demonstrat ion projects under th is section were not implemented.” In the CY 2006, 2007, and 2008 PFS final rules with comment period (70 FR 70266, 71 FR 69707, 72 FR 66325, respectively), we include d a discussion of the st rategy that would be used to assess budget neutrality (BN) and the method for adjusting chiropractor fees in the event the demonstration resulted in costs higher than those that would occur in the absence of the

demonstration. We stated that BN would be as sessed by determining the change in costs based

### CMS-1600-FC 1247

on a pre-post comparison of total Medicare costs fo r beneficiaries in the demonstration and their counterparts in the control groups and the rate of change for specific diagnoses that are treated by chiropractors and physicians in the de monstration sites and control site s. We also stated that our analysis would not be limited to only review of chiropractor claims because the costs of the expanded chiropractor services may have an imp act on other Medicare co sts for other services.

In the CY 2010 PFS final rule with comment period (74 FR 61926), we discussed the evaluation of this demonstration conducted by Bra ndeis University and the two sets of analyses

used to evaluate BN. In the “All Neuromusculo skeletal Analysis,” which compared the total

Medicare costs of all beneficiaries who received services for a neuromuscu loskeletal condition in

the demonstration areas with those of benefici aries with similar characteristics from similar geographic areas that did not participate in the demonstration, the total effect of the demonstration on Medicare spending was $114 milli on higher costs for benefi ciaries in areas that participated in the demonstrati on. In the “Chiropractic User Analysis,” which compared the

Medicare costs of beneficiar ies who used expanded chirop ractic services to treat a

neuromusculoskeletal condition in the demonstration areas, with those of beneficiaries with similar characteristics who used chiropractic serv ices as was currently covered by Medicare to

treat a neuromusculoskeletal condition from sim ilar geographic areas that did not participate in the demonstration, the total effect of the dem onstration on Medicare spending was a $50 million

increase in costs. As explained in the CY 2010 PFS final rule, we based the BN estimate on the “Chiropractic User Analysis” because of its focus on users of chiropractic se rvices rather than all

Medicare beneficiaries with neuromusculoskelet al conditions, as the latter included those who did not use chiropractic services and who may not have become users of chiropractic services

### CMS-1600-FC 1248

even with expanded coverage for them (74 FR 61926 through 61927). Users of chiropractic services are most likely to have been aff ected by the expanded coverage provided by this demonstration. Cost increases and offsets, such as reductions in hospitalizations or other types of ambulatory care, are more likely to be observed in this group. As explained in the CY 2010 PFS final rule (74 FR 61927), because the costs of this demonstration were higher than expected and we did not anticipate a reduction to the PFS of greater than 2 percent per year, we finalized a policy to recoup $50 million in expenditures from this demonstration over a 5-year period, from CYs 2010 through 2014 (74 FR 61927). Specifically, we are recouping $10 million for each such year through adjustments to the chiropractic CPT codes. Payment under th e PFS for these codes will be reduced by approximately 2 percent. We be lieve that spreading th is adjustment over a longer period of time will minimize its potential negative impact on chiropractic practices. For the CY 2013 PFS, our Office of the Ac tuary (OACT) estimated chiropractic expenditures to be approximately $470 million, which reflected the statutory 26.5 percent reduction to PFS payments schedule d to take effect that year. The statute was subsequently amended to impose a zero percent PFS update for CY 2013 instead of the 26.5 percent reduction. In large part because of the change in the PFS update, OACT now estimates CY 2013 chiropractic expenditures to be approximately $580 million. Because of the change in projected chiropractic expenditures, we now expect to recoup approximately $11.6 million from the 2 percent payment reduction for chiropractic CPT codes in CY 2013. We expect to complete the required BN ad justment by recouping the remainder of the chiropractic expenditures in CY 2014. For each y ear of this recoupment, we have provided OACT’s projected chiropractic expenditures ba sed on previous year’s data. While OACT’s

### CMS-1600-FC 1249

projections have included the statutory reductions to physicia n payments, the statute was amended in each year to avoid these reductions . As a result, Medicare expenditures for chiropractic services during the recoupment were higher than the OACT projections. Chiropractic services expenditu res during the recoupment period have been as follows: $540 million in 2010; $520 million in 2011; and $580 million in 2012. In total, CMS recouped $32.8 million over the years of 2010, 2011 and 2012. OACT no w projects chiropractic expenditures to be approximately $580 million in 2013. A 2 per cent recoupment percentage for chiropractic services would result in approximately $11.6 million in 2013. For the years 2010 through 2013, CMS would have recouped approximately $44.4 million of the $50 million required for budget neutrality. In 2014, CMS is reducing the recoupment percen tage for the chiropractic codes to ensure the recoupment does not exceed the $50 million re quired for budget neutrality. OACT estimates chiropractic expenditures in CY 2014 will be approximately $560 million based on Medicare spending for chiropractic services for the mo st recent available year and reflecting an approximate 20 percent reduction to the physician fee schedule conversion factor scheduled to take effect under current law. CMS plans to recoup the remaining funds, approximately $5.6 million, and will reduce chiropractic CPT codes (CPT codes 98940, 98941, and 98942) by the appropriate percentage. We will reflect this reduction only in the payment files used by the Medicare contractors to proce ss Medicare claims rather than through adjusting the RVUs. Avoiding an adjustment to the RVUs preserves th e integrity of the PFS, particularly since many private payers also base payment on the RVUs. We received no comments regarding this provisio n of the PFS. Therefore, as finalized in the CY 2010 PFS regulation and reiterated in the CYs 2011 through 2013 PFS regulations, we

### CMS-1600-FC 1250

are implementing this methodology and recoupi ng excess expenditures u nder the chiropractic services demonstration from PFS payment for the ch iropractor codes as set forth above. This recoupment addresses the statutory requireme nt for BN and appropriately impacts the chiropractic profession that is di rectly affected by the demonstr ation. We intend for CY 2014 to be the last year of th is required recoupment.

### CMS-1600-FC 1251

N. Physician Self-Referral Pr ohibition: Annual Update to the List of CPT/HCPCS Codes

1. General Section 1877 of the Act prohibits a physicia n from referring a Medi care beneficiary for certain designated health services (DHS) to an entity with which the physician (or a member of the physician’s immediate family) has a financial relationship, unless an exception applies. Section 1877 of the Act also prohibits the DHS entity from submitting claims to Medicare or billing the beneficiary or any other entity for Me dicare DHS that are furnished as a result of a prohibited referral. Section 1877(h)(6) of the Act and §411.351 of our regulations specify that the following

services are DHS:

● Clinical laboratory services

● Physical therapy services

● Occupational therapy services

● Outpatient speech-language pathology services

● Radiology and certain other imaging services

● Radiation therapy services and supplies

● Durable medical equipment and supplies

● Parenteral and enteral nutrients, equipment, and supplies

● Prosthetics, orthotics, and prosthetic devices and supplies

● Home health services

● Outpatient prescription drugs

● Inpatient and outpati ent hospital services

### CMS-1600-FC 1252

2. Annual Update to the Code List a. Background In §411.351, we specify that the entire scope of f our DHS categories is defined in a list of CPT/HCPCS codes (the Code List), which is updated annually to account for changes in the most recent CPT and HCPCS Level II publications . The DHS categories defined and updated in

this manner are:

● Clinical laboratory services.

● Physical therapy, occupational thera py, and outpatient speech-language pathology

services.

● Radiology and certain other imaging services.

● Radiation therapy services and supplies.

The Code List also identifies those items a nd services that may qualify for either of the following two exceptions to the phys ician self-referral prohibition:

● EPO and other dialysis-re lated drugs (§411.355(g)).

● Preventive screening tests, immunizations, or vaccines (§411.355(h)). The definition of DHS at §411.351 excludes serv ices that are reimbursed by Medicare as part of a composite rate (unl ess the services are specifically identified as DHS and are themselves payable through a composite rate, such as home health and inpatient and outpatient hospital services). E ffective January 1, 2011, EPO and dialysis -related drugs furnished in or by an ESRD facility (except drugs for which there are no injectable equivalents or other forms of administration), have been reimbursed under a co mposite rate known as the ESRD prospective payment system (ESRD PPS) (75 FR 49030). Acco rdingly, EPO and any dialysis-related drugs that are paid for under ESRD PPS are not DHS and are not listed among the drugs that could

### CMS-1600-FC 1253

qualify for the exception at §411.355(g) for EPO and other dialysis-related drugs furnished in or by an ESRD facility. Drugs for which there are no injectable equiva lents or other forms of administration were scheduled to be paid under ESRD PPS begi nning January 1, 2014 (75 FR 49044). However, on January 3, 2013, Congress enacted the American Taxpayer Relief Act of 2012 (ATRA), (Pub. L.

112 -240), which will delay payment of these drugs under ESRD PPS until January 1, 2016. In the meantime, such drugs furnished in or by an ESRD facility are not re imbursed as part of a composite rate and thus, are DHS. For purpos es of the exception at §411.355(g), only those drugs that are required for the efficacy of dialys is may be identified on the List of CPT/HCPCS Codes as eligible for the exception. As we have explained previously in the 2010 PFS final rule (75 FR 73583), we do not believe that any drugs fo r which there are no injectable equivalents or other forms of administration are required for th e efficacy of dialysis. We therefore have not included any such drugs on the list of drugs that can qualify for the exception. The Code List was last updated in Addendum J of the CY 2013 PFS final rule with comment period. b. Response to Comments We received no public comments relating to the Code List that became effective January 1, 2013.

c. Revisions Effective for 2014 The updated, comprehensive Code List effective January 1, 2014, appears as

Addendum K in this final rule with comment period and is availa ble on our website at http://www.cms.gov/Medicare/Fraud-and-Abuse/ PhysicianSelfReferral/List_of_Codes.html

. Additions and deletions to the Code List c onform it to the most recent publications of

### CMS-1600-FC 1254

CPT and HCPCS Level II, and to changes in Medicare coverage policy and payment status. Tables 89 and 90 identify the additio ns and deletions, re spectively, to the comprehensive Code List that become effective January 1, 2014. Tables 89 and 90 also identify

the additions and deletions to th e list of codes used to identify the items and services that may qualify for the exceptions in §411.355(g) (regardi ng dialysis–related out patient prescription drugs furnished in or by an ES RD facility) and in §411.355(h) (regarding pr eventive screening tests, immunizations, and vaccines). We will consider comments regarding the codes listed in Tables 89 and 90.

Comments will be considered if we receive them by the date specified in the “DATES” section of this final rule with comment period. We will not consider any comment that advocates a substantive change to any of the DHS defined in §411.351.

### CMS-1600-FC 1255

TABLE 89: Additions to the Phys ician Self-Referral List of CPT 1/ 

### HCPCS Codes CLINICAL LABORATORY SERVICES {No additions} PHYSICAL THERAPY, OCCUPATIONAL THERAPY, AND OUTPATIENT SPEECH-LANGUAGE PATHOLOGY SERVICES 92521 Evaluation of speech fluency 92522 Evaluate speech production 92523 Speech sound lang comprehen 92524 Behavral qualit analys voice 97610 Low frequency non-thermal US G0460 Autologous PRP for ulcers 

### RADIOLOGY AND CERTAIN OTHER IMAGING SERVICES 97610 Low frequency non-thermal US 0330T Tear film img uni/bi w/i&r 0331T Heart symp image plnr 0332T Heart symp image plnr spect 0346T+ Ultrasound elastography A9520 Tc99 Tilmanocept diag 0.5mci A9586 Florbetapir F18 C9734 U/S trtmt, not leiomyomata 

### RADIATION THERAPY SERVICES AND SUPPLIES C9734 U/S trtmt, not leiomyomata EPO AND OTHER DIALYSIS-RELATED DRUGS {No additions} PREVENTIVE SCREENING TE STS, IMMUNIZATIONS AND VACCINES 90661 Flu vacc cell cult prsv free 90673 Flu vacc RIV3 no preserv 90685 Flu vac no prsv 4 val 6-35 m 90686 Flu vac no prsv 4 val 3 yrs+ 90688 Flu vacc 4 val 3 yrs plus im

### CMS-1600-FC 1256

1 CPT codes and descriptions only are copyright 2013 AMA. All rights are reserved and applicable FARS/DFARS clauses apply.



### TABLE 90: Deletions from the Ph ysician Self-Referral List of CPT 1/ 

### HCPCS Codes CLINICAL LABORATORY SERVICES {No deletions} PHYSICAL THERAPY, OCCUPATIONAL THERAPY, AND OUTPATIENT SPEECH-LANGUAGE PATHOLOGY SERVICES 

### 0183T Wound Ultrasound 92506 Speech/hearing evaluation RADIOLOGY AND CERTAIN OTHER IMAGING SERVICES {No deletions}

RADIATION THERAPY SERVICES AND SUPPLIES {No deletions}

EPO AND OTHER DIALYSIS-RELATED DRUGS {No deletions} PREVENTIVE SCREENING TE STS, IMMUNIZATIONS AND VACCINES {No deletions}

1 CPT codes and descriptions only are copyright 2013 AMA. All rights are reserved and applicable FARS/DFARS clauses apply.

### CMS-1600-FC 1257

IV. Collection of Information Requirements Under the Paperwork Reduction Act of 1995, we are required to provi de 60-day notice in

the Federal Register and solicit public comment before a co llection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues:

● The need for the information collection and its usefulness in carrying out the proper functions of our agency.

● The accuracy of our estimate of the information collection burden.

● The quality, utility, and clarity of the information to be collected.

● Recommendations to minimize the inform ation collection burden on the affected public, including automate d collection techniques. In the CY 2014 PFS proposed rule (78 FR 4350 6), we solicited public comment on each of these issues for the following sections of th is document that contain information collection requirements (ICRs). No comments were received. A. ICRs Regarding Medical Services Covera ge Decisions that Rela te to Health Care Technology (§405.211) Over the past 18 years, there have been approximately 4000 IDE studies approved that are potentially coverable by Medicare, averaging to about 222 per year. If the sponsor requests a second review, the documents will have to be sent again. We estimate that this may happen 5-8 percent of the time. Adding a nother 8 percent brings the total estimate to approximately 240 requests per year.

### CMS-1600-FC 1258

To derive average costs, we used data from the U.S. Bureau of Labor Statistics for all salary estimates. The salary estimates include th e cost of fringe benefits , calculated at 35 percent of salary, which is based on the May 2013 Employer Costs for Employee Compensation report by the Bureau. The burden associated with the requirements under §405. 211 is the time and effort it will take a study sponsor that is seeking Medicare cove rage related to an FDA-approved Category A or B IDE to prepare the request a nd supporting documents (a copy of each of the following: FDA approval letter of the IDE, IDE study protocol, IRB approval letter, NCT number, and supporting materials (as needed). For the most part, the documents are c opies of communications between the study sponsor and the FDA. Accordingly, we estimate th at it will take 1 to 2 hours for an executive administrative assistant in a medical device comp any to prepare the required information. We estimate that for 240 requests per year, that the total time to be expende d by all potential study sponsors is estimated to be between 240 to 480 hour s. In deriving costs to the public, we used the Bureau of Labor Statistics May 2012 estim ate of $24.14 + 35% in fringe benefits for estimated hourly wage of $32.59 for an executive administrative assistant (occupation code 43- 6011). We estimate the cost to be betw een $7.822 - $15,643 per study, for 222 potential IDE study sponsors plus a potential 19 additional submissions. If the average time of a study is 2 years, the annualized cost is $3,911 - $15,643 years applications or $16.30 - $39.59 per study. The higher figure is used for the burden calcu lation in our PRA submission to OMB. The preceding requirements and burden estimates will be submitted to OMB under OCN 0938-New (CMS-10511). B. ICRs Regarding the Physician Quality Reporting System (PQRS) (§414.90)

### CMS-1600-FC 1259

We are making certain revisions to §414.90, prim arily to include our final policies for the qualified clinical data registry option. Please note that we solicited but re ceived no specific public comment either supporting or opposing the im pact statements related to our proposals for the PQRS. Therefore, our estimates below are ba sed on the final requirements for participation in the PQRS in 2014. We are revising §414.90(b), (c), and (e) and adding new paragraphs (h) and (j) of §414.90 to indicate our requirements for the qualifi ed clinical data registry option, including specifying the criteria for satisfactory participati on in a qualified clinical data registry for the 2014 PQRS incentive and 2016 PQRS payment ad justment. In addition, we are revising §414.90(g) and newly redesignated § 414.90(i) to indicate the addi tion of a new PQRS reporting mechanism for group practices – the CMS-certified survey vendor – as well as to specify the satisfactory reporting criteria for the 2014 PQRS incentive and 2016 PQRS payment adjustment.

While the sections contain information collecti on requirements regarding the input process and the endorsement of consensus-based quality meas ures, this rule does not revise any of the information collection requirements or burden estimates that are associated with those provisions. The preamble of this final rule with comm ent period discusses the background of the PQRS, provides information about the measures a nd reporting mechanisms that are available to eligible professionals and group practices who choose to particip ate in 2014, and provides the criteria for satisfactory reporting data on quality measures in 2014 (for the 2014 PQRS incentive and the 2016 PQRS payment adjustment). Below are our burden estimates for participating in the PQRS in 2014 which are subject to OMB review/approval under OCN 0938-1059. (CMS10276).

### CMS-1600-FC 1260

1. Participation in the 2014 PQRS In the CY 2013 PFS final rule with comment pe riod, we provided estimates related to the impact of the requirements we finalized fo r the PQRS for 2014. Since we are adding and modifying certain requirements for the 2014 PQRS, this section modifies the impact statement provided in the CY 2013 PFS final rule with co mment period for reporting in 2014. Please note

that we will base our estimates on informa tion found in the 2011 Physician Quality Reporting System and eRx Reporting Experience and Tr ends (hereinafter “the PQRS Reporting Experience”). This report contai ns the latest data we have gath ered on PQRS participation. The PQRS Reporting Experience is available at http://www.cms.gov/Medicare/Quality-InitiativesPatient-Assessment-Instruments/ PQRS/index.html?redirect=/PQRS/ . According to the 2011 Reporting Experience Report, over 1 million professionals were eligible to participate in the PQRS. A total of $261,733,236 in PQRS incenti ves was paid by CMS for the 2011 program year, which encompassed 26,515 practices that included 266,521 eligible professionals (or approximately 27 percent of the professionals elig ible to participate). The average incentive earned for PQRS in 2011 per each individually -participating eligible professional was $1,059. As we noted in our impact statement last y ear, we expect that, due to the implementation of payment adjustments beginning in 2015, participation in the PQRS will rise incrementally to approximately 300,000 eligible professionals a nd 400,000 eligible profe ssionals in 2013 and 2014, respectively. We believe our estimate of 400,000 eligible professionals participating in PQRS in 2014 remains accurate. With respect to the estimated amount of incentives earned, for 2014, eligible professionals can earn a 0.5 per cent incentive (that is , a bonus payment equal to 0.5 percent of the total allowed part B charges for covered pr ofessional services under the PFS furnished by the

### CMS-1600-FC 1261

eligible professional during th e reporting period) for sati sfactory reporting. Based on information drawn from the 2011 Reporting Expe rience and our particip ation estimate, we believe that, out of the 400,000 eligible professiona ls we expect to participate in the PQRS in 2014, the PQRS will distribute 2014 incentives to a pproximately (27 percent of 1 million eligible professionals) 270,000 eligible professionals. At $1,059 per eligible profe ssional, the PQRS will distribute approximately $286 million in incentive payments for 2014. We believe these incentive payments will help offset the co st eligible professionals may undertake for participating in the PQRS for the applicable year.

We note that the total burden associated with participating in the PQRS is the time and effort associated with indicating intent to part icipate in the PQRS, if applicable, and submitting PQRS quality measures data. When establis hing these burden estimates, we assume the following:

● For an eligible professional or group practice using the clai ms, qualified registry, qualified clinical data registry, or EHR-based reporting mechanisms, we assume that the eligible professional or group practice will attempt to repo rt quality measures data with the intention of earning the 2014 PQRS incentive and not simply to avoid the 2016 PQRS payment adjustment. Therefore, an eligible professional or group practice will report on 9 measures.

● With respect to labor costs, we belie ve that a billing cl erk will handle the administrative duties associated with participa ting, while a computer analyst will handle duties related to reporting PQRS quality measures. Acco rding to the Bureau of Labor Statistics, the mean hourly wage for a billing clerk is approx imately $16/hour whereas the mean hourly wage for a computer analyst is approximately $40/hour.

### CMS-1600-FC 1262

Please note that these estimates do not reflect to tal costs estimates for participating in PQRS, but rather the adjustments (+/-) as sociated with the changes for 2014. 2. Burden Estimate on Participation in the 2014 PQ RS – New Individual E ligible Professionals: Preparation For an eligible professional who wishes to participate in PQRS as an individual, the eligible professional need not indicate his/her in tent to participate. Instead, the eligible professional may simply begin re porting quality measures data . Therefore, these burden estimates for individual eligible professionals participating in PQRS are based on the reporting mechanism the individual eligible professional ch ooses. However, we believe a new eligible professional or group practice will spend 5 hour s—which includes 2 hours to review PQRS measures list, review the various reporting optio ns, and select a reporting option and measures on which to report and 3 hours to review the meas ure specifications and develop a mechanism for incorporating reporting of the sele cted measures into their office work flows. Therefore, we

believe that the initial administrative costs asso ciated with participa ting in PQRS will be approximately $80 ($16/hour x 5 hours). 3. Burden Estimate on Participation in th e 2014 PQRS via the Claims-based Reporting Mechanism – Individual Eligible Professionals Historically, the claims-based reporting m echanism is the most widely used reporting mechanism in PQRS. In 2011, 229,282 of the 320,422 e ligible professional s (or 72 percent of eligible professionals) used the claims-based reporting mechanism. In the CY 2013 PFS final rule with comment period, we estimated th at approximately 320,000 eligible professionals, whether participating individually or in a group practice, will participate in PQRS by CY 2014

### CMS-1600-FC 1263

(77 FR 69338). We believe this estimate shoul d be further modified to reflect a lower participation estimate in 2014 for the following reasons:

● We are eliminating the option to report measures groups via claims for the 2014 PQRS incentive and 2016 PQRS payment adjustment.

● We are increasing the number of measures th at an eligible profe ssional must report to meet the criteria for satisfactory reporting for th e 2014 PQRS incentive from 3 measures to 9, but lower the reporting thre shold to 50 percent.

● We are removing the claims-based repor ting mechanism as an option for reporting certain individual quality measures. We estimate that approximately 230,000 eligible professionals (that is, the same number of eligible professionals who participated in the PQRS using the claims-based reporting mechanism in 2011) will participate in the PQRS using the claims-based reporting mechanism. Therefore, we estimate that approximately 58 percent of the eligible professionals participating in PQRS will use the claims-based reporting mechanism. With respect to an eligible pr ofessional who participated in PQRS via claims, the eligible professional must gather the re quired information, select the appropriate quality data codes (QDCs), and include the appropr iate QDCs on the claims they submitted for payment. PQRS will collect QDCs as additional (optional) lin e items on the existing HIPAA transaction 837-P and/or CMS Form 1500 (OCN 0938-0999). Based on our experience with Physician Voluntary Reporting Program (PVRP), we continue to estimate that the time needed to perform all the steps necessary to report each measure via claims ranges from 0.25 minutes to 12 minutes, depending on the complexity of the measure. Therefore, the time spent reporting 9 measures ranges from 2.25 minutes to 108 minutes. Using an average la bor cost of $40/hour, we estimated that the

### CMS-1600-FC 1264

time cost of reporting for an eligible professi onal via claims ranges from $1.50 (2.25 minutes or 0.0375 hours x $40/hour) to $72.00 (108 minutes or 1.8 hours x $40/hour) per reported case. With respect to how many cases an eligible prof essional will report when using the claims-based reporting mechanism, we established that an elig ible professional needs to report on 50 percent of the eligible professional’s applicable cases. The actual number of case s on which an eligible professional reports varies depending on the numb er of the eligible professional’s applicable cases. However, in prior years, when the repo rting threshold was 80 percent for claims-based reporting, we found that the median number of reporting cases for each measure was 9. Since we reduced the reporting threshold to 50 percen t, we estimate that the average number of reporting cases for each measure will be reduced to 6. Based on these estimates, we estimate that the total cost of reporting for an eligib le professional choosing the claims-based reporting mechanism ranges from ($1.50/per reported case x 6 reported cases) $9.00 to ($72.00/reported case x 6 reported cases) $432. 4. Burden Estimate on PQRS Participation in CY 2014 via the Qualified Registry, Qualified Clinical Data Registry, or EHR Reporting Mechanisms We noted previously that we estimated a si gnificant reduction in the number of eligible professionals using the claims-based reporting m echanism to report PQRS quality measures data in 2014. Specifically, we estimated that appr oximately 230,000 eligible professionals would participate in the PQRS using the claims-bas ed reporting mechanism in 2014. Therefore, we

estimated that the remainder of the eligible professionals (17 0,000) would participate in PQRS using either the qualified registr y, qualified clinical da ta registry, EHR (using either a direct EHR or EHR data submission vendor), or the GPRO web interface re porting mechanisms.

### CMS-1600-FC 1265

With respect to participation in a qualified regi stry or qualified clini cal data registry, we are combining our estimates for the number of eligible professionals we believe will use the qualified registry and qualified clinical data registry reporti ng mechanisms for the 2014 PQRS incentive and 2016 PQRS payment adjustment. We are combining these estimates because we believe that, at least for this initial year, many of the registries that become qualified clinical data registries will also be existing qua lified registries. As such, we an ticipate there will be little to no additional, new registries that will submit quality measures data on behalf of eligible professionals to the PQRS for purposes of the 2014 PQRS incentive and 2016 PQRS payment adjustment. In 2011, approximately 50,215 (or 16 percen t) of the 320,422 eligib le professionals participating in PQRS used the registry-based re porting mechanism. We believe the number of eligible professionals and group practices using a qualified regist ry or qualified clinical data registry would remain the same, given that elig ible professionals use re gistries for functions other than PQRS and therefore, would not obtain a qualified registry or qu alified clinical data registry solely for PQRS reporting in CY 2014. Please note that this estimate would include participants choosing the new qualifie d clinical data registry reporting mechanism. At least in its initial stage, we believe most of the vendors that would be appr oved to be a qualified clinical data registry would be ex isting qualified registries. In 2011, 560 (or less than 1 percent) of the 320,422 eligible professionals participating in PQRS used the EHR-based reporting mechanis m. We believe the number of eligible professionals and group practices using the EHR- based reporting mechanism will increase as eligible professionals become mo re familiar with EHR products and more eligible professionals participate in programs encouraging use of an EHR, such as the EHR Incentive Program. In

### CMS-1600-FC 1266

particular, we believe eligible professionals a nd group practices will transition from using the claims-based to the EHR-based reporting mech anisms. We estimate that approximately 50,000 eligible professionals (which is the same estimat e as we are providing for eligible professionals who use the qualified registry or qualified clinical data regist ry-based reporting mechanisms), whether participating as an i ndividual or part of a group practice, will use the EHR-based reporting mechanism in CY 2014. With respect to an eligible professional or group practice wh o participated in PQRS via a qualified registry, qualifie d clinical data regist ry, direct EHR product, or EHR data submission vendor’s product, we believe there will be little to no burden associated for an eligible professional to report quality measures data to CM S, because the eligible professional will select a reporting mechanism to submit the quality measures data on the eligible pr ofessional’s behalf. Therefore, the actual reporting is performed by the reporting mechanis m, not the eligible professional. While we noted that there may be start-up costs associated with purchasing a qualified registry, direct EHR product, or EHR data s ubmission vendor, we believe that an eligible professional or group practice will not use a qualified registry, qualif ied clinical data registry, or EHR data submission vendor produc t, or purchase a direct EHR product, solely for the purpose of reporting PQRS quality measures. Therefore, we have not included the cost of using a qualified registry, qualifie d clinical data regist ry, or EHR data submi ssion vendor product, or purchasing a direct EHR produc t in our burden estimates. 5. Burden Estimate on PQRS Participation in CY 2014 – Group Practices Please note that with the exception of th e estimates associated with a group selfnominating to participate in the PQRS under th e group practice reporti ng option (GPRO), this

### CMS-1600-FC 1267

section only contains our estimates for group prac tices who participate in the PQRS under the

GPRO via the GPRO web interf ace reporting mechanism. We not e that the burden associated with reporting quality measures for group practices using the qua lified registry or EHR-based reporting mechanisms are included in the estimates we provided for the qualified registry or EHR-based reporting mechanisms above. Acco rding to the 2011 PQRS and eRx Experience report, of the 101 practices partic ipating in the GPRO, 54 of thes e practices participated using the GPRO web interface (formerly referred to as “the GPRO tool”). We estimate that because are applying the value-based payment modifier to all group practices of 10 or more eligible professionals, we estimate that approximately 30 percent of such group pr actices, or about 5,100 group practices, will participat e in the PQRS under the GPRO for purposes of the 2014 PQRS incentive and the 2016 payment adjustment. In addition, we estimate that of the 5,100 group practices that are expected to self-nominate to participate in the PQRS under the GPRO, approximately 70,000 eligible profe ssionals (that is, the remainder of the eligible professionals not participating in PQRS using th e claims, qualified registry, qualif ied clinical data registry, or EHR-based reporting mechanisms), representing about 30 percent of the groups with 100 or more eligible professionals (or about 340 groups), will choose to participate in PQRS using the GPRO web interface for purposes of the 2014 PQRS incentive and the 2016 PQRS payment adjustment. Unlike eligible professionals who choose to re port individually, e ligible professionals choosing to participate as part of a group pract ice under the GPRO will need to indicate their intent to participate in PQRS as a group pract ice. The total burden for group practices who submit PQRS quality measures data via the GPRO web-interface will be the time and effort associated with submitting this data. To su bmit quality measures data for PQRS, a group

### CMS-1600-FC 1268

practice needs to (1) be selected to particip ate in the PQRS GPRO and (2) report quality measures data. With respect to the administrative duties for being selected to participate in PQRS as a group practice, we believe it take s approximately 6 hours – including 2 hours to decide to participate in PQRS as a group pract ice; 2 hours to self-nominate, and 2 hours to undergo the vetting process with CM S officials – for a group practice to be selected to participate in PQRS GPRO for the applicable year. Theref ore, we estimate that the cost of undergoing the GPRO selection process is ($16/hour x 6 hours) $96. With respect to reporting PQRS quality m easures using the GPRO web-interface, the total reporting burden is the time and effort associated with the group practice submitting the quality measures data (that is, completed th e data collection interf ace). Based on burden estimates for the PGP demonstration, which uses the same data submission methods, we estimate the burden associated with a group practice completing the data collection interface is approximately 79 hours. Therefore, we estimate that the report cost for a group practice to submit PQRS quality measures data for an a pplicable year is ($40/hour x 79 hours) $3,160. In addition to the GPRO web interface, please note that we are fi nalizing a new reporting mechanism that is available to group practices comprised of 25+ eligible professionals: the certified survey vendor for CG-CAHPS measures. With respect to using a certified survey vendor, we believe there is little to no burden associated for a group practice to report the CG CAHPS survey data to CMS because the certif ied survey vendor will report the CG CAHPS survey questions on the group practice’s behalf. Although there may be start-up costs associated with using a certified survey vendor, we believe that a group practice wi ll not use a certified survey vendor solely for the purpose of re porting the CG CAHPS survey for the PQRS.

### CMS-1600-FC 1269

Therefore, we have not include d the cost of using a certified survey vendor in our burden

estimates. 6. Burden Estimate on PQRS Vendor Participation in CY 2014 Aside from the burden of eligible profe ssionals and group practic es participating in PQRS, we believe that entities that wish to become qualified clinical data registries will incur costs associated with participating in PQRS. However, we believe that the burden associated with participating in PQRS for these entities is very similar to the burden associated with existing qualified registries participating in PQRS. Based on the number of registries that have self-nominated to become a qualified PQRS registry in prior program years, we estimated th at approximately 50 registries will self-nominate to be considered a qualified regist ry for PQRS. With respect to qualified registries and qualified clinical data registries, the total burden for qualified registries and qualified clinical data registries that submit quality measures data will be the time and effort associated with submitting this data. To submit quality measures data for the 2014 PQRS reporting periods , a registry needs to (1) become qualified for the applicable year and (2) report qua lity measures data on behalf of its eligible professionals. With respect to administrative duties related to the qualification process, we estimate that it takes a total of 10 hours – including 1 hour to complete the self-nomination statement, 2 hours to interv iew with CMS, 2 hours to calculate numerators, denominators, and measure results for each measur e the registry wished to report using a CMSprovided measure flow, and 5 hours to complete an XML submission – to become qualified to report quality measures data unde r the PQRS. Therefore, we es timate that it costs a registry approximately ($16.00/hour x 10 hours) $160 to become qualified to submit quality measures

data on behalf of its e ligible professionals.

### CMS-1600-FC 1270

With respect to the reporting of quality measures data, the burden associated with reporting is the time and effort associated with th e registry and qualified c linical data registry calculating quality measures results from the data submitted to the registry by its eligible professionals, submitting numerator and denominator data on quality measures, and calculating

these measure results. In addition to submitti ng numerator and denominator data on quality measures and calculating these measure results, qua lified clinical data regi stries are required to perform additional functions, such as providing feedb ack to its eligible professionals at least 4 times a year and establishing a method to benc hmark and, where appropriate, risk adjust its quality measure results. We believe , however, that registries and qua lified clinical data registries already perform these functions fo r their eligible professionals irrespective of participating in PQRS. Therefore, we believe there is little to no additional burden associated with reporting quality measures data. Whether there is a ny additional reporting burden varies with each registry, depending on the registry’s level of sa vvy with submitting quality measures data for PQRS. For CY 2014, we are finalizing a new PQ RS option that includes a new reporting mechanism – the qualified clinical data registry. In this final ru le with comment period, we set forth the requirements for a vendor to become qualified to become a qualified clinical data registry. Under the final require ments, we note that a vendor can be both a traditional qualified registry and qualified clinical data registry under the PQRS. Ind eed, as we noted previously, we believe that many of the entities th at will seek to become qualified cl inical data registries will be similar to the existing qu alified registries. In addition, th e process that we are adopting for becoming a qualified clinical data registry is similar to the process for becoming a qualified

### CMS-1600-FC 1271

registry. Therefore, we do not believe this new reporting mechanism will impact our registry

estimates. 7. Summary of Burden Estimates on Participation in the 2014 PQRS - Elig ible Professionals and

Vendors

TABLE 91: Estimated Costs for Reporting PQRS Quality Measures Data for Eligible Professionals Hours Cases Number of Measures Hourly Rate Cost Per Respondent Number of Respondents Total Cost Individual Eligible Professional (EP): Preparation 5.0 1 N/A $16 $80 320,422 $32,000,0 00

Individual EP: Claims 0.2 6 3 $40 $144 230,000 $33,120,0 00 Individual EP: Registry N/A 1 N/A N/A Minimal 40,422 N/A 1

Individual EP: EHR N/A 1 N/A N/A Minimal 50,000 N/A 1

Group Practice: Self-Nomination 6.0 1 N/A $16 $96 5,100 $489,600 Group Practice: Reporting 79 1 N/A $40 $3,160 340 $1,074,40 0 1 We believe that eligible professionals who choose to report quality measures data to PQRS using a registry, a qualified clinical data registry, an EHR, or an EHR data submission vendor are already submitting quality measures data for other purposes. Therefore, th ere is little to no burden associated with reporting the quality data to CMS under PQRS. TABLE 92: Estimated Costs to Registries to Participate in PQRS Hours Hourly Rate Cost Numb er of Respondents Total Cost Registry: Self-Nomination 10 $16 $160 50 $8,000

C. The Medicare EHR Incentive Program The Medicare EHR Incentive Program provides in centive payments to eligible professionals, eligible hospitals, and CAHs that demonstrate meani ngful use of certified EHR technology. We believe any burden or impact associated with this rule’s changes to the EHR Incen tive Program are already

### CMS-1600-FC 1272

absorbed by OCN 0938-1158 and are not subject to additional OMB review under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

D. Submission of PRA-Related Comments If you comment on these information collection and recordkeeping requirements, please submit your comments to the Office of Information and Regul atory Affairs, Office of Management and Budget, Attention: CMS Desk Officer, [CMS-1600-FC] Fax: (202) 395-6974; or

Email: OIRA_submission@omb.eop.gov

. PRA-specifc comments must be received on/by [OFR--INSERT DATE 30-DAYS AFTER THE DATE

OF PUBLICATION IN THE FEDERAL REGISTER ]. 

### V. Response to Comments Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We considered all comments we received by the date and time specified in the “DATES” section of this preamble, and, when we proceeded with a subsequent document, we responded to the comments in the preamble to that document. VI. Waiver of Proposed Rulemaking and Delay in Effective Date We ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment on the proposed rule. The notice of proposed rulemaking includes a

reference to the legal authority under which the rule is proposed, and the terms and substance of the proposed rule or a description of the subject s and issues involved. This procedure can be waived, however, if an agency finds good cause that a notice-and-comment procedure is impracticable, unnecessary, or contrary to the public interest and incorporat es a statement of the finding and its reasons in the rule issued.

### CMS-1600-FC 1273

We utilize HCPCS codes for Medicare payment purposes. The HCPCS is a national coding system comprised of Level I (CPT) codes and Level II (HCPCS National Codes) that are intended to provide uniformity to coding proced ures, services, and supplies across all types of medical providers and suppliers. Level I (CPT) codes are copyrighted by the AMA and consist of several categories, including Category I codes which are 5-digit numeric codes, and Category III codes which are temporary codes to track em erging technology, services, and procedures. The AMA issues an annual update of the CPT code set each Fall, with January 1 as the effective date for implementing the updated CPT codes. Th e HCPCS, including both Level I and Level II codes, is similarly updated annually on a CY basi s. Annual coding changes are not available to the public until the Fall immediately preceding th e annual January update of the PFS. Because of the timing of the release of these new codes, it is impracticable for us to provide prior notice

and solicit comment on these codes and the RVUs assigned to them in a dvance of publication of the final rule that implements the PFS. Yet, it is imperative that these coding changes be accounted for and recognized timely under the P FS for payment because services represented by these codes will be provided to Medicare beneficiaries by physicians during the CY in which they become effective. Moreover, regulat ions implementing HIPAA (42 CFR parts 160 and 162) require that the HCPCS be us ed to report health care servi ces, including services paid under the PFS. We assign interim RVUs to any ne w codes based on a review of the AMA RUC recommendations for valuing these services. We also assign interim RVUs to certain codes for which we did not receive specific AMA RUC re commendations, but that are components of new combined codes. We set interim RVUs for the component codes in order to conform them to the value of the combined code. Finally, we assi gn interim RVUs to certain codes for which we received AMA RUC recommendations for only one component (work or PE) but not both. By

### CMS-1600-FC 1274

reviewing these AMA RUC recommendations for the ne w codes, we are able to assign RVUs to services based on input from the medical commun ity and to establish payment for them, on an interim basis, that corresponds to the relative resources associated with furnishing the services. We are also able to determine, on an interim fi nal basis, whether the codes will be subject other payment policies. If we did not assign RVUs to new codes on an interim basis, the alternative would be to either not pay for these services during the initial CY or have each Medicare contractor establish a payment rate for these new codes. We believe both of these alternatives are contrary to the public interest, particularly since the AMA RUC process allows for an

assessment of the valuation of th ese services by the medical comm unity prior to our establishing payment for these codes on an interim basis. Ther efore, we believe it would be contrary to the public interest to delay esta blishment of fee schedule payment amounts for these codes until notice and comment procedur es could be completed. For the reasons previously outlined in this section, we find good cause to waive the notice of proposed rulemaking for the interim RVUs fo r selected procedure codes identified in

Addendum C and to establish RVUs for these codes on an interim final basis. We are providing a 60-day public comment period.

Section II.E. of this final ru le with comment period discu sses our review and decisions regarding the AMA RUC recommendations. Si milar to the AMA RUC recommendations for new and revised codes previously discu ssed, due to the timing of the AMA RUC recommendations for the services identified as po tentially misvalued codes, it is impracticable for CMS to provide for notice and comment regard ing specific revisions prior to publication of this final rule with comment period. We believe it is in the public inte rest to implement the

revised RVUs for the codes that were identified as misvalued, and that have been reviewed and

### CMS-1600-FC 1275

re-evaluated by the AMA RUC, on an interim fi nal basis for CY 2013. The revisions of RVUs for these codes will establish a more appropriate payment that better corresponds to the relative resources associated with furnishing these servic es. A delay in implementing revised values for these misvalued codes would not only perpetuate the known misvaluation for these services, it would also perpetuate a distortion in the payment for other services under the PFS. Implementing the changes on an interim basis a llows for a more equi table distribution of payments across all PFS services. We believe a delay in implementation of these revisions would be contrary to the public interest, particularly since the AMA RUC process allows for an

assessment of the valuation of these services by the medical community prior to the AMA

RUC’s recommendation to CMS. For the reason s previously described, we find good cause to waive notice and comment procedures with respec t to the misvalued codes and to revise RVUs

for these codes on an interim final basis. We are providing a 60-day public comment period. In the absence of an appropriation for CY 2014 or a Continuing Resolution, there was a lapse in funding, which lasted from Octobe r 1 through October 16, 2013, when only excepted operations continued. This largely excluded wo rk on this final rule with comment period. Accordingly, most of the work on this final rule with comment period was not completed in accordance with our usual schedule for final CY pa yment rules, which aims for an issuance date of November 1 followed by an effective date of Ja nuary 1 to ensure that the policies are effective at the start of the calendar year to which they apply. We ordinarily provide a 60-day de lay in the effective date of final rules after the date they are issued. The 60-day delay in effective date can be waived, however, if the agency finds for good cause that the delay is impracticable, unnecessar y, or contrary to the public interest, and the agency incorporates a statement of the findings and its reasons in the rule issued. We believe it

### CMS-1600-FC 1276

would be contrary to the public in terest to delay the effective date of the MPFS portions of this final rule with comment period. In accordance with section 1848(b)(1) of the statute, the MPFS is a calendar-year payment system. We typically issue the final rule by N ovember 1 of each year to comply with section 1848(b)(1 ) of the statute and to ensure that the payment policies for the system are effective on January 1, the first day of the calendar year to which the policies are intended to apply. If the effec tive date of this final rule w ith comment period is delayed by 60 days, the MPFS for CY 2014 adopted in this final rule with comment period will not be effective as of the beginning of the payment year. Secti on 1848(d) of the Act requir es application of an update, calculated using the SGR methodology, to th e CF that is used to calculate payments under the MPFS. The statutory update is required to be applied to the CF for the previous year in order to calculate the CF for the succeeding year . As such, it is necessary that the statutory update to the CF take effect as of the beginning of the calendar year in order to adjust MPFS payments as prescribed by statute. In addition, in this final rule with comment period, we review and revise values for specific services, and adopt or revise other policies that relate to the MPFS for CY 2014 or future years. Section 1848(c)(2)(B )(ii)(II) of the Act requir es that adjustments to

relative values under the MPFS be ma de in a budget neutral manner. We believe that, in order to preserve budget neutrality as required by statute and to promote an orderly transition to a new payment year, it is in the public interest for all of these M PFS policies to take effect in conjunction with the statutory update to the CF for CY 2014, and we find that it would be contrary to the public interest to do otherwise. We are finalizing the MPFS in this CY 2014 final rule with comment period and, in order to adhere to the statutory requirements that an adjusted CF apply to services furnished on or after January 1, 2014, and that budget neutrality be maintained, this final rule must be effective on that date.

### CMS-1600-FC 1277

Additionally, we believe it would be contrary to the public inte rest to delay the effective date of the PQRS, value-based payment modifi er, EHR incentive program, and Medicare Shared Savings provisions of this final rule with comment period. PQRS incentives for 2014 and PQRS payment adjustments for 2016, as authorized under subsections (m) and (a) of section 1848, will be based, in part, on the policie s finalized in this final rule , including the requirements for reporting quality data beginning January 1, 2014. The CY 2016 value-based payment modifier, as authorized under section 1848(p), will be dete rmined according to final policies adopted in this rule and using a performance period that begins on January 1, 2014. We are also finalizing policies in this rule that pertain to the repor ting of clinical quality measures for the EHR Incentive Program during CY 2014, which will be used to determine incentive payments and payments adjustments under sections 1848(o) and (a )(7), respectively. If the effective date of this final rule with comment period is delayed by 60 days, the PQRS policies adopted in this

final rule will not be effective until after Januar y 1, 2014. This would be c ontrary to the public’s interest in ensuring that eligible professionals have the fu ll benefit of reporting during CY 2014, receive appropriate incentive paym ents in a timely manner, and th at their physician fee schedule payments in 2016 are properly adjusted to refl ect their reporting on quality measure data in 2014. For the same reasons, we believe it would be contrary to the public interest to delay by 60 days the effective date of the policies related to th e CY 2016 value-based payment modifier and the EHR Incentive Program. In addition, under th e authority provided by section 1899(b)(3)(D) of the Act, certain PQRS requirements regardi ng reporting for purposes of incentive payments and the payment adjustment under section 1848(a)(8) were incorporated in the Medicare Shared Savings Program. Accordingly, for the same reas ons described above, it would also be contrary

### CMS-1600-FC 1278

to the public interest to delay the effective date of the provisions regarding PQRS reporting under the Medicare Shared Savings Program beyond January 1, 2014. Therefore, we find good cause to waive the 60- day delay in the eff ective date for this final rule with comment period as explained above. We note th at our waiver of the delayed effective date only applies to the provisions noted above that are being adopt ed in this final rule with comment period. The delayed effective date is not waived for other provisions of this final rule with comment period, and t hose policies will be effective on [OFR--INSERT date that is 60 days after OFR display]

.

### CMS-1600-FC 1279

VII. Regulatory Impact Analysis

A. Statement of Need This final rule with comment period is necessary to make payment and policy changes under the Medicare PFS and to make required stat utory changes under the Affordable Care Act (Pub. L. 111–148), the Middle Class Tax Relief a nd Job Creation Act of 2012 (Pub. L. 112-96), the American Taxpayer Relief Act (ATRA) of 2013 (Pub. L. 112-240), and other statutory changes. This final rule with comment period also is necessary to make changes to other Part B related policies. B. Overall Impact We have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (Septemb er 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (February 2, 2013), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (Mar ch 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congre ssional Review Act (5 U.S.C. 804(2)). Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive imp acts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically si gnificant effects ($100 million or more in any 1 year). We estimate, as discussed below in this section, that the PFS provi sions included in this final rule with comment period will redistribute mo re than $100 million in 1 year. Therefore, we estimate that this rulemaking is “economically significant” as measured by the $100 million

### CMS-1600-FC 1280

threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we have prepared a RIA that, to the best of our ability, presents the costs and benefits of the rulemaking. The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities incl ude small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.0 million in any 1 year (for details see the SBA's website at http://www.sba.gov/content/small-business-sizestandards# (refer to the 620000 seri es)). Individuals and states ar e not included in the definition of a small entity. The RFA requires that we analyze regulator y options for small businesses and other entities. We prepare a regulatory flexibility analys is unless we certify that a rule would not have a significant economic impact on a substantial nu mber of small entities. The analysis must include a justification concerning the reason actio n is being taken, the kinds and number of small entities the rule affects, and an explanation of any meaningful op tions that achieve the objectives with less significant adverse economic impact on the small entities. For purposes of the RFA, physicians, NPPs , and suppliers are considered small businesses if they generate revenues of $10 million or less ba sed on SBA size standards. Approximately 95 percent of providers and suppliers are considered to be small entities. There are over 1 million physicians, other practitioners, and medical suppliers that receive Medicare payment under the PFS. Because many of the affected entities are small entit ies, the analysis and discussion provided in this section as well as elsewhere in this final rule with comment period is intended to comply with the RFA requirements. In addition, section 1102(b) of th e Act requires us to prepare an RIA if a rule may have a

### CMS-1600-FC 1281

significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of s ection 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hosp ital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations a nd has fewer than 100 beds. We are not preparing an analysis for section 1102( b) of the Act because we have determined, and the Secretary certifies, that this final rule wi th comment period would not have a significant impact on the operations of a substant ial number of small rural hospitals.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits on state, local, or tribal gove rnments or on the private sector before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2013, that threshold is approximately $141 million. This final rule with comment period will im pose no mandates on state, local, or tribal governments or on the private sector. Executive Order 13132 establishes certain requirem ents that an agency must meet when it promulgates a final rule with comment period (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Since th is regulation does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable. We have prepared the following analysis, whic h together with the information provided in the rest of this preamble, meets all assessm ent requirements. The analysis explains the rationale for and purposes of this final rule with comment period; details the costs and benefits of the rule; analyzes alternatives; and presents th e measures we would use to minimize the burden

on small entities. As indicated elsewhere in this final rule with comment period, we are

### CMS-1600-FC 1282

implementing a variety of changes to our regula tions, payments, or payment policies to ensure that our payment systems reflect changes in medi cal practice and the relati ve value of services, and to implement statutory provisions. We provide information for each of the policy changes in

the relevant sections of this final rule with comment period. We are unaware of any relevant federal rules that duplicate, overl ap, or conflict with this final rule with comment period. The

relevant sections of this final rule with co mment period contain a desc ription of significant alternatives if applicable. C. Relative Value Unit (RVU) Impacts 1. Resource-Based Work, PE , and Malpractice RVUs Section 1848(c)(2)(B)(ii)(II) of the Act requires that increase s or decreases in RVUs may not cause the amount of expenditures for the year to differ by more than $20 million from what expenditures would have been in the absence of th ese changes. If this threshold is exceeded, we make adjustments to preserve budget neutrality. Our estimates of changes in Medicare reve nues for PFS services compare payment rates for CY 2013 with payment rates for CY 2014 usi ng CY 2012 Medicare utilization as the basis for the comparison. The payment impacts reflect averages for each specialty based on Medicare utilization. The payment impact for an indi vidual physician could vary from the average and would depend on the mix of services the physicia n furnishes. The average change in total revenues would be less than the impact displaye d here because physicians furnish services to both Medicare and non-Medicare patients and sp ecialties may receive substantial Medicare revenues for services that are not paid under th e PFS. For instance, independent laboratories receive approximately 83 percent of their Medicare revenues from clinical laboratory services that are not paid under the PFS.

### CMS-1600-FC 1283

We note that these impacts do not include the effect of the January 2014 conversion factor changes under current law. The annual updat e to the PFS conversion factor is calculated based on a statutory formula that measures actual versus allowed or “target” expenditures, and applies a sustainable growth rate (SGR) calcula tion intended to control growth in aggregate Medicare expenditures for physicia ns’ services. This update met hodology is typically referred to as the “SGR” methodology, although the SGR is only one component of the formula. Medicare PFS payments for services are no t withheld if the percentage increase in actual expenditures exceeds the SGR. Rather, the PFS update, as spec ified in section 1848(d)(4) of the Act, is adjusted to eventually bring actua l expenditures back in line with targets. If act ual expenditures exceed allowed expenditures, the update is reduce d. If actual expenditures are less than allowed expenditures, the update is increased. By la w, we are required to apply these updates in accordance with sections 1848(d) and (f) of the Act, and any negative updates can only be averted by an Act of the Congress. Although th e Congress has provided temporary relief from negative updates for every year since 2003, a long-term solution is critical. We are committed to working with the Congress to reform Medicar e physician payments to provide predictable payments that incentivize quality and efficiency in a fiscally responsible way. We provide our most recent estimate of the SGR and physician upda te for CY 2014 in section II.G. of this final rule with comment period. Table 93 shows the payment impact by Medicare specialty. To the extent that there are year-to-year changes in the volume and mix of services provided by physicians, the actual impact on total Medicare revenues will be diffe rent from those shown in Table 93 (CY 2014 PFS

Final Rule with Comment Period Estimated Impact on Total Allowed Charges by Specialty )

. The following is an explanation of the in formation represented in Table 93:

### CMS-1600-FC 1284

● Column A (Specialty) : The Medicare specialty code as reflected in our physician/supplier enro llment files.

● Column B (Allowed Charges) : The aggregate estimated PFS allowed charges for the specialty based on CY 2012 utilization and CY 2013 rates. That is, allowed charges are the PFS

amounts for covered services and include coinsura nce and deductibles (which are the financial responsibility of the beneficiary). These amounts have been summed across all services furnished by physicians, practitione rs, and suppliers within a speci alty to arrive at the total allowed charges for the specialty.

● Column C (Impact of Work and Malpractice (MP) RVU Changes) : This column shows the estimated CY 2014 impact on total allowed charges of the changes in the work and malpractice RVUs, including the impact of change s due to new, revised, and misvalued codes.

● Column D (Impact of PE RVU Changes): This column shows the estimated CY 2014 impact on total allowed charges of the changes in the PE RVUs, in cluding the impact of changes due to new, revised, and misvalue d codes, the statutory change to the equipment utilization rate from 75 percent to 90 percent for expensive di agnostic imaging equipment, the implementation of the ultrasound recommendation to replace ex pensive ultrasound rooms with less expense portable ultrasound units, and other mis cellaneous and minor provisions.

● Column E (Impact of Adjusting the RVUs to Match the Revised MEI Weights) : This

column shows the estimated CY 2014 combined im pact on total allowed charges of the changes in the RVUs and conversion factor adjustment resulting from adjusting the RVUs to match the revised MEI weights.

● Column F (Cumulative Impact): This column shows the estimated CY 2014 combined impact on total allowed charges of all the changes in the previous columns.

### CMS-1600-FC 1285

TABLE 93: CY 2014 PFS Final Rule with Co mment Period Estimated Impact Table: Impacts of Work, Practice Expense, and Malpractice RVUs, and the MEI Adjustment* Impact of RVU Changes

(A) Specialty (B)

Allowed Charges

(mil) (C) Impact of Work and MP

RVU Changes (D) Impact of PE RVU Changes (E) Impact of Adjusting the RVUs to Match the Revised

MEI Weights (F) Combined

Impact

TOTAL $87,552 0% 0% 0% 0% 01-ALLERGY/IMMUNOLOGY $214 0% 0% -3% -3% 02-ANESTHESIOLOGY $1,871 0% 0% 1% 1% 03-CARDIAC SURGERY $357 0% 0% 2% 2% 04-CARDIOLOGY $6,461 0% 2% -1% 1% 05-COLON AND RECTAL SURGERY $159 0% 0% 0% 0% 06-CRITICAL CARE $276 0% 0% 2% 2% 07-DERMATOLOGY $3,123 -1% 1% -2% -2% 08-EMERGENCY MEDICINE $2,946 0% 0% 2% 2% 09-ENDOCRINOLOGY $449 0% 0% 0% 0% 10-FAMILY PRACTICE $6,402 0% 0% 0% 0% 11-GASTROENTEROLOGY $1,909 -1% -1% 0% -2% 12-GENERAL PRACTICE $536 0% 0% 0% 0% 13-GENERAL SURGERY $2,254 0% 0% 0% 0% 14-GERIATRICS $235 0% 0% 1% 1% 15-HAND SURGERY $151 0% 0% -1% -1% 16-HEMATOLOGY/ONCOLOGY $1,896 0% 0% -2% -2% 17-INFECTIOUS DISEASE $639 0% 0% 2% 2% 18-INTERNAL MEDICINE $11,503 0% 0% 1% 1% 19-INTERVENTIONAL PAIN MGMT $644 -1% -2% -1% -4% 20-INTERVENTIONAL RADIOLOGY $221 -1% 0% -1% -2% 21-MULTISPECIALTY CLINIC/OTHER PHY $80 0% -1% 1% 0% 22-NEPHROLOGY $2,134 0% 0% 1% 1% 23-NEUROLOGY $1,509 0% -1% 0% -1% 24-NEUROSURGERY $718 0% 0% 0% 0% 25-NUCLEAR MEDICINE $51 0% 0% 0% 0% 27-OBSTETRICS/GYNECOLOGY $693 0% 2% -1% 1% 28-OPHTHALMOLOGY $5,609 0% 0% 0% 0% 29-ORTHOPEDIC SURGERY $3,702 -1% -1% 0% -2%

### CMS-1600-FC 1286

Impact of RVU Changes

(A) Specialty (B)

Allowed Charges

(mil) (C) Impact of Work and MP

RVU Changes (D) Impact of PE RVU Changes (E) Impact of Adjusting the RVUs to Match the Revised

MEI Weights (F) Combined

Impact

30-OTOLARNGOLOGY $1,133 0% -1% -1% -2% 31-PATHOLOGY $1,141 -4% -2% 0% -6% 32-PEDIATRICS $64 0% 0% 0% 0% 33-PHYSICAL MEDICINE $1,007 0% -1% 0% -1% 34-PLASTIC SURGERY $372 0% 0% 0% 0% 35-PSYCHIATRY $1,181 4% 1% 1% 6% 36-PULMONARY DISEASE $1,783 0% 0% 1% 1% 37-RADIATION ONCOLOGY $1,788 0% 3% -2% 1% 38-RADIOLOGY $4,655 0% -2% 0% -2% 39-RHEUMATOLOGY $553 0% -2% -2% -4% 40-THORACIC SURGERY $335 0% 0% 1% 1% 41-UROLOGY $1,864 0% -1% 0% -1% 42-VASCULAR SURGERY $931 0% -1% -1% -2% 43-AUDIOLOGIST $57 0% 1% -1% 0% 44-CHIROPRACTOR $729 5% 6% 1% 12% 45-CLINICAL PSYCHOLOGIST $587 6% -1% 3% 8% 46-CLINICAL SOCIAL WORKER $414 6% -2% 4% 8% 47-DIAGNOSTIC TESTING FACILITY $790 0% -6% -5% -11% 48-INDEPENDENT LABORATORY $818 -2% 0% -3% -5% 49-NURSE ANES / ANES ASST $1,061 0% 0% 3% 3% 50-NURSE PRACTITIONER $1,954 0% 0% 1% 1% 51-OPTOMETRY $1,116 0% 0% -1% -1% 52-ORAL/MAXILLOFACIAL SURGERY $45 0% 1% -2% -1% 53-PHYSICAL/OCCUPATIONAL THERAPY $2,818 0% 1% -1% 0% 54-PHYSICIAN ASSISTANT $1,414 0% 0% 0% 0% 55-PODIATRY $1,998 0% 0% -1% -1% 56-PORTABLE X-RAY SUPPLIER $113 0% 2% -4% -2% 57-RADIATION THERAPY CENTERS $63 0% 5% -6% -1% 98-OTHER $25 0% 0% 1% 1%

### CMS-1600-FC 1287

*Table 93 shows only the payment impact on PFS services. These impacts use a constant conversion factor and thus do not include the effects of the January 2014 conversion factor change required under current law.



### 2. CY 2014 PFS Impact Discussion a. Changes in RVUs The most widespread specialty impacts of th e RVU changes are generally related to the following major factors. The firs t factor is our rescaling of the RVUs to match the weights assigned to work, PE and MP in th e revised MEI, as discussed in se ction II.B. of this final rule with comment period. A conversion factor (CF) adjustment is also made to assure budget neutrality for this adjustment in RVUs. The second factor involves se rvice-level changes to RVUs for new, revised, and mi svalued services. In addi tion, a number of other changes contribute to the impacts shown in Table 93. Ot her factors include a st atutory change that requires us to use a 90 percent equipment utilization rate rather than the previously used 75 percent for expensive diagnostic imaging equipment as discussed in section II.A.2.f. of this final rule with comment period, update s to direct practice expense i nputs for ultrasound services, as

discussed in section II.A.5. of th is final rule with comment peri od and adjustments to time for some services, as discussed in section II.B .3.c. of this final rule with comment period. b. Combined Impact Column F of Table 93 displays the estimat ed CY 2014 combined im pact on total allowed charges by specialty of all the RVU changes. These impacts range from an increase of 12 percent for chiropractors to a decrease of 10 percent for diagnos tic testing facilities. Again, these impacts are estimated prior to the a pplication of the negative CY 2014 CF update applicable under the Act. Table 94 (Impact of Final rule with comme nt period on CY 2014 Payment for Selected Procedures) shows the estimated impact on total payments for selected high volume procedures

### CMS-1600-FC 1288

of all of the changes discussed previously. We have included CY 2014 payment rates with and

without the effect of the CY 2014 negative PFS CF update for comparison purposes. We selected these procedures from among the mo st commonly furnished by a broad spectrum of physician specialties. The change in both facility rate s and the nonfac ility rates ar e shown. For an explanation of facility and nonfacility PE, we re fer readers to Addendum A of this final rule with comment period.CMS-1600-FC 1289TABLE 94: Impact of Final Rulewith Comment Period on CY 2014Payment for Selected Procedures*FacilityNon-Facility

CPT/ HCPCS 1 MODShort Descriptor CY 2013 2 CY 2014 3 (pre update) % Change (pre update) CY 2014 4 (post update) % Change (post update) CY 2013 2 CY 2014 3 (pre update) % Change (pre update) CY 2014 4 (post update) % Change (post update)11721 Debride nail 6 or more $24.50 $25.30 3%$18.59 -24% $44.91 $44.89 0% $33.00 -27%17000 Destruct premalg lesion $57.16 $53.09 -7% $39.02 -32% $83.36 $74.82 -10% $54.99 -34%27130 Total hip arthroplasty $1,454.48 $1,393.78 -4% $1,024.43 -30% NA NA NA NA NA27244 Treat thigh fracture $1,242.18 $1,260.53 1% $926.49 -25% NA NA NA NA NA27447 Total knee arthroplasty $1,552.81 $1,393.06 -10% $1,023.91 -34% NA NA NA NA NA33533 Cabg arterial single $1,906.31 $1,958.13 3% $1,439.23 -25% NA NA NA NA NA35301 Rechanneling of artery $1,096.22 $1,201.38 10% $883.02 -19% NA NA NA NA NA43239 Egd biopsy single/multiple $174.54 $152.13 -13% $111.82 -36% $359.28 $404.02 12% $296.96 -17%66821 After cataract laser surgery $325.26 $323.50 -1% $237.78 -27% $344.99 $341.32 -1% $250.87 -27%66984 Cataract surg w/iol 1 stage $667.87 $671.59 1% $493.62 -26% NA NA NA NA NA67210 Treatment of retinal lesion $520.55 $521.95 0% $383.64 -26% $538.92 $539.41 0% $396.47 -26%71010 Chest x-ray 1 view frontal NA NA NA NA NA $23.82 $23.87 0% $17.55 -26%71010 26 Chest x-ray 1 view frontal $8.85 $9.26 5% $6.81 -23% $8.85 $9.26 5% $6.81 -23%77056 Mammogram both breasts NA NA NA NA NA $114.66 $115.44 1% $84.85 -26%77056 26 Mammogram both breasts $42.19 $44.18 5% $32.47 -23% $42.19 $44.18 5% $32.47 -23%77057 Mammogram screening NA NA NA NA NA $81.66 $82.30 1% $60.49 -26%77057 26 Mammogram screening $34.02 $35.63 5% $26.19 -23% $34.02 $35.63 5% $26.19 -23%77427 Radiation tx management $178.28 $185.62 4% $136.43 -23% $178.28 $185.62 4% $136.43 -23%88305 26 Tissue exam by pathologist $36.74 $38.12 4% $28.02 -24% $36.74 $38.12 4% $28.02 -24%90935 Hemodialysis one $71.11 $73.04 3% $53.68 -25% NA NA NA NA NA92012 Eye exam establish patient $53.08 $54.51 3% $40.07 -25% $87.44 $86.58 -1% $63.63 -27%92014 Eye exam&tx estab pt $80.29 $82.30 2% $60.49 -25% $126.23 $125.41 -1% $92.18 -27%93000 Electrocardiogram complete NA NA NA NA NA $18.37 $16.75 -9% $12.31 -33%93010 Electrocardiogram report $8.17 $8.55 5% $6.28 -23% $8.17 $8.55 5% $6.28 -23%93015 Cardiovascular stress test NA NA NA NA NA $79.61 $75.53 -5% $55.52 -30%CMS-1600-FC 1290FacilityNon-Facility

CPT/ HCPCS 1 MODShort Descriptor CY 2013 2 CY 2014 3 (pre update) % Change (pre update) CY 2014 4 (post update) % Change (post update) CY 2013 2 CY 2014 3 (pre update) % Change (pre update) CY 2014 4 (post update) % Change (post update)93307 26 Tte w/o doppler complete $44.23 $45.60 3% $33.52 -24% $44.23 $45.60 3% $33.52 -24%93458 26 L hrt artery/ventricle angio $315.73 $326.00 3% $239.61 -24% $315.73 $326.00 3% $239.61 -24%98941 Chiropract manj 3-4 regions $30.62 $35.27 15% $25.92 -15% $36.40 $41.33 14% $30.38 -17%99203 Office/outpatient visit new $75.19 $76.96 2% $56.56 -25% $108.19 $107.95 0% $79.35 -27%99213 Office/outpatient visit est $49.67 $51.30 3% $37.71 -24% $72.81 $72.68 0% $53.42 -27%99214 Office/outpatient visit est $76.55 $78.74 3% $57.87 -24% $106.83 $107.24 0% $78.82 -26%99222 Initial hospital care $134.73 $138.24 3% $101.60 -25% NA NA NA NA NA99223 Initial hospital care $198.01 $203.44 3% $149.53 -24% NA NA NA NA NA99231 Subsequent hospital care $38.11 $39.19 3% $28.81 -24% NA NA NA NA NA99232 Subsequent hospital care $70.09 $71.97 3% $52.90 -25% NA NA NA NA NA99233 Subsequent hospital care $101.05 $104.03 3% $76.47 -24% NA NA NA NA NA99236 Observ/hosp same date $212.30 $218.40 3% $160.53 -24% NA NA NA NA NA99239 Hospital discharge day $104.79 $106.88 2% $78.56 -25% NA NA NA NA NA99283 Emergency dept visit $59.88 $61.64 3% $45.30 -24% NA NA NA NA NA99284 Emergency dept visit $114.66 $117.93 3% $86.68 -24% NA NA NA NA NA99291 Critical care first hour $217.75 $223.75 3% $164.45 -24% $272.18 $273.62 1% $201.11 -26%99292 Critical care addl 30 min $109.55 $112.23 2% $82.49 -25% $120.78 $122.92 2% $90.34 -25%99348 Home visit est patient NA NA NA NA NA $82.34 $84.08 2% $61.80 -25%99350 Home visit est patient NA NA NA NA NA $173.52 $177.78 2% $130.67 -25%G000 Immunization admin NA NA NA NA NA $25.86 $24.94 -4% $18.33 -29%1CPT codes and descriptions are copyright 2013 American Medical Association. All Rights Reserved. Applicable FARS/DFARS apply.2Payments based on the 2013 conversion factor of 34.0230.3Payments based on the 2013 conversion factor of 34.0230, adjusted to 35.6446 to include the budget neutrality adjustment.4Payments based on the estimated 2014 conversion factor of 27.2006.

### CMS-1600-FC 1291

D. Effect of Changes to Medicare Telehealth Services Under the PFS

As discussed in section II.E.3. of this fina l rule with comment pe riod, we are finalizing our policy to refine our definition of rural as it applies to HPSAs e ligible for telehealth services as well as add transitional care management services to the list of Medicare telehealth services. Although we expect these changes to increase access to care in rural areas, based on recent

utilization of current Medicare telehealth services , including services simi lar to transitional care management, we estimate no significant impact on PFS expenditures from the additions. E. Geographic Practice Cost Indices (GPCIs) Based upon statutory requirements we ar e updating the GPCIs for each Medicare payment locality. The GPCIs incorporate the us e of updated data and cost share weights as discussed in II.E. The Act requ ires that updated GPCIs be phase d in over 2 years. Addendum D

shows the estimated effects of the revised GP CIs on area GAFs for the transition year (CY 2014) and the fully implemented year (CY 2015). The GAFs reflect the use of the updated underlying GPCI data, and the revised cost share weights. The GAFs are a weighted composite of each area’s work, PE and malpractice expense GPCIs using the national GPCI cost share weights. Although we do not actually use the GAFs in com puting the fee schedule payment for a specific service, they are useful in comparing overall areas costs and payments. The actual geographic adjustment to payment for any actual service will be different from the GAF to the extent that the proportions of work, PE and malp ractice expense RVUs for the se rvice differ from those of the

GAF. The most significant changes occur in 22 paym ent localities where the fully implemented (CY 2015) GAF moves up by more than 1 percent ( 11 payment localities) or down by more than 2 percent (11 payment localities) . The impacts on the GPCIs are primarily attributed to the

### CMS-1600-FC 1292

expiration of the 1.000 work GPCI floor. The us e of updated underlying GPCI data and cost share weights has a minimal impact on locality GAFs. The total impact of the GPCI revisions is

shown in the 2015 GPCI values of Addendum E. We note that the CY 2014 physician work GPCI s and summarized geographic adjustment factors (GAFs) published in Addenda D and E refl ect the elimination of the 1.0 work GPCI floor provided in section 1848 (e )(1)(E) of the Act, which is set to expire prior to the implementation

of the CY 2014 PFS. F. Other Provisions of the Final Rule with Comment Period Regulation 1. Rebasing and Revising Medicare Economic Index We estimate that there is no impact of the changes to the MEI for CY 2014. 2. Coverage of Items and Services furnis hed in FDA-Approved Investigational Device Exemption (IDE) Clinical Trials We are finalizing our proposal of a transparen t centralized review process that would be more efficient by reducing the burden for stakeh olders. Once the IDE coverage process is centralized, there will be a single entity making the IDE coverage decision. This also eliminates duplicative reviews by Medicare local contractors and the nume rous applications sent to contractors by stakeholders requ esting IDE coverage. We belie ve that a centralized review process will not significantly reduce the num ber of IDE devices cu rrently covered. 3. Ultrasound Screening for Abdominal Aortic Aneurysms

As discussed in section III.B. of this final rule with comment period, section 1861(s)(2)(AA) of the Act, with implementi ng regulations at §410.19, authorizes Medicare coverage of ultrasound screening for abdominal ao rtic aneurysms (“AAA sc reening”). We are finalizing our proposal to modi fy §410.19 to allow coverage of one-time AAA screening without

### CMS-1600-FC 1293

receiving a referral as part of the IPPE, for benefici aries that meet certain other eligibility criteria (a family history of AAA or, for men aged 65-75, a history of smoking). Approximately 45 percent of men aged 65-75 have a history of smoking. It is unknown how many individuals have a family history of AAA or how many beneficiaries will avail them selves of this benefit. Therefore, the impact of this change is unknown for CY 2014. 4. Modification to Medicare Coverage of Colorectal Cancer Screening

As discussed in section III.C. of this final rule with comment period, sections 1861(s)(2)(R) and 1861(pp)(1) of the Act, a nd implementing regulations at 42 CFR 410.37 authorize Medicare coverage of screening FOBT . We are finalizing our proposal to modify §410.37(b) to allow attending physicians, physician as sistants, nurse practi tioners, and clinical nurse specialists to furnish orders for screeni ng FOBTs. Although there may be an increase in utilization, particularly in rura l areas, it is unknown how many i ndividuals will avail themselves of this benefit. Therefore, the impact of this change is unknown for CY 2014.

5. Ambulance Fee Schedule

As discussed in section III.D. of this fi nal rule with comment period, section 604(a) through (c) of the ATRA require the extension of cer tain add-on payments for ground ambulance

services and the extension of certain rural area designations for purposes of air ambulance payment. In addition, as discu ssed in section III.D. of this final rule with comment period, section 637 of the ATRA (which added section 1834(l)(15) of the Act) specifies that the fee schedule amount otherwise applicable under the preceding provisions of section 1834(l) of the Act shall be reduced by 10 percent for ambulance services furnished on or after October 1, 2013, consisting of non-emergency basic life support (BLS) services involving transport of an individual with end-stage renal disease for rena l dialysis services (a s described in section

### CMS-1600-FC 1294

1881(b)(14)(B) of the Act) furnished other than on an emergency basis by a provider of services or a renal dialysis facility. The ambulance ex tender provisions and the mandated 10 percent rate decrease discussed above are enacted through legi slation that is self-implementing. We are finalizing our proposal to amend the regulation text at §414.610 only to conform the regulations to these self-implementing statutory requirement s. As a result, we are not making any policy proposals associated with these legislative provisions and ther e is no associated regulatory impact 6. Clinical Laboratory Fee Schedule We are finalizing our proposal to add language to the Code of Federal Regulations to codify authority provided by statute and to establish a process under which we will systematically reexamine the payment amounts established under the CLFS to determine if changes in technology for the delivery of that se rvice warrant an adjustment to the payment amount. We are also finalizing our proposal of a definition for the term technological changes. Adjustments made under the new process could both increase fee schedule amounts and provide for reductions in existing amounts. We ca nnot estimate a net impact at this time. 7. Liability for Overpayments to or on Behalf of Individuals including Pa yments to Providers or

Other Persons

As discussed in section III.F. of this final rule with comm ent period, we are finalizing the regulation as proposed and changing the timeframe for the “without fault” presumptions from 3 years to 5 years 

### As a result, there would be an estimated savings of $0.5 billion over 10 years. 8. Physician Compare Web Site There will be no impact for the Physician Compare website because we are not collecting any information for the Physician Compare website.

### CMS-1600-FC 1295

9. Physician Payment, Efficiency, and Qua lity Improvements – Physician Quality Reporting System (PQRS) In the CY 2013 PFS final rule with comment pe riod, we provided estimates related to the impact of the requirements we finalized for th e PQRS for 2014. Since we are making additional proposals for 2014, this section modifies the im pact statement provided for 2014 in the CY 2013 PFS final rule with comment period. Please note that we will base our estimates on information found in the 2011 Physician Quality Reporting System and eRx Reporting Experience and Trends (hereinafter “the PQRS Reporting Experience”). This report contains the latest data we have gathered on PQRS participation. Th e PQRS Reporting Experience is available at http://www.cms.gov/Medicare/Quality -Initiatives-Patient-AssessmentInstruments/PQRS/index.html?redirect=/PQRS/ . According to the 2011 Reporting Experience Report, over 1 million professionals were eligible to participate in the PQRS. A total of $261,733,236 

### in PQRS incentives was paid by CMS for the 2011 program year, which encompassed 26,515 practices that included 266,521 eligible professionals (or approximately 27 percent of the professionals eligible to participate) 

### . The average incentive earned for PQRS in

2011 per each individually-participating eligible professional was $1,059. 

### As we noted in our impact statement last y ear, we expect that, due to the implementation of payment adjustments beginning in 2015, participation in the PQ RS would rise incrementally to approximately 300,000 eligible professionals and 400,000 eligib le professionals in 2013 and 2014, respectively. We believe our estimate of 400,000 eligible professionals participating in PQRS in 2014 remains accurate. With respect to the estimate amount of incen tives earned, for 2014, eligible professionals can earn a 0.5 percent incentive (that is, a bonus payment e qual to 0.5 percent of the total

### CMS-1600-FC 1296

allowed Part B charges for covered professional services under the PFS furnished by the eligible professional during the reporting pe riod) for satisfactory reporti ng. Based on information drawn from the 2011 Reporting Experience and our particip ation estimate, we believe that, out of the 400,000 eligible professionals we expect to par ticipate in the PQRS in 2014, the PQRS will distribute 2014 incentives to approximately (27 percent of 1 million eligible professionals) 270,000 eligible professionals. At $1,059 per eligible professional, the PQRS would distribute approximately $286 million in incentive payments in 2014. We believe these incentive payments will help offset the cost eligible pr ofessionals may undertake for participating in the PQRS for the applicable year.

We note that the total burden associated with participating in the PQRS is the time and effort associated with indicating intent to part icipate in the PQRS, if applicable, and submitting PQRS quality measures data. When establis hing these burden estimates, we assume the following:

● For an eligible professional or group pract ice using the claims, re gistry, or EHR-based reporting mechanisms, we assume that the eligib le professional or group practice would attempt to report PQRS quality measures data with the intention of ear ning the 2014 PQRS incentive, not simply to avoid the 2016 PQRS payment adjustment . Therefore, an eligible professionals or group practice would report on 9 measures.

● With respect to labor costs, we belie ve that a billing cl erk will handle the administrative duties associated with participa ting, while a computer analyst will handle duties related to reporting PQRS quality measures. Acco rding to the Bureau of Labor Statistics, the mean hourly wage for a billing clerk is approx imately $16/hour whereas the mean hourly wage for a computer analyst is approximately $40/hour.

### CMS-1600-FC 1297

For an eligible professional who wishes to participate in the PQRS as an individual, the eligible professional need not indi cate his/her intent to participate. The eligible professional may simply begin reporting quality measures data. Therefore, these burden estimates for individual eligible professionals participating in the PQ RS are based on the re porting mechanism the individual eligible professional chooses. However, we believe a new eligible professional or group practice would spend 5 hours—which includes 2 hours to review the PQRS measures list, review the various reporting op tions, and select a reporting op tion and measures on which to report and 3 hours to review the measure sp ecifications and develop a mechanism for incorporating reporting of the sele cted measures into their office work flows. Therefore, we

believe that the initial administrative costs associ ated with participating in the PQRS would be approximately $80 ($16/hour x 5 hours). With respect to an eligible professional who participates in the PQRS via claims, the eligible professional must gath er the required information, sel ect the appropriate quality data codes (QDCs), and include the appropriate QDCs on the claims they submit for payment. The PQRS collects QDCs as additional (optional) li ne items on the existing HIPAA transaction 837-P and/or CMS Form 1500 (OCN: 0938-0999). Based on our experience with Physician Voluntary Reporting Program (PVRP), we continue to estimate that the time needed to perform all the steps necessary to report each measure via claims will range from 0.25 minutes to 12 minutes, depending on the complexity of the measure. Therefore, the time spent reporting 9 measures would range from 2.25 minutes to 108 minutes. Using an average labor cost of $40/hour, we estimate that time cost of reporting for an elig ible professional via cl aims would range from $1.50 (2.25 minutes or 0.0375 hours x $40/hour) to $72.00 (108 minutes or 1.8 hours x $40/hour) per reported case. With respect to how many cases an eligib le professional would

### CMS-1600-FC 1298

report when using the claims-based reporting mechanism, we proposed that an eligible professional would need to report on 50 percent of the e ligible professional’s applicable cases. The actual number of cases on which an elig ible professional woul d report would vary depending on the number of the eligible professi onal’s applicable cases. However, in prior years, when the reporting th reshold was 80 percent, we f ound that the median number of reporting cases for each measure was 9. Since we are reducing the reporting threshold to 50 percent, we estimated that the average numbe r of reporting cases for each measure would be reduced to 6. Based on these estimates, we es timated that the total cost of reporting for an eligible professional choosing the claims-b ased reporting mechanism would range from ($1.50/per reported case x 6 repor ted cases) $9.00 to ($72.00/reported case x 6 reported cases) $432. With respect to an eligible professional or group practice who participates in the PQRS via a qualified registry, direct EHR product, EHR data submission vendor product, or qualified clinical data registry, we believe there would be little to no burden associated for an eligible professional or group practice to report PQRS quality measures data to CMS, because the selected reporting mechanism submits the quality measures data for the eligible professional. Although we noted that there may be start-up co sts associated with purchasing a qualified registry, direct EHR product, EHR data submission vendor, or qualifie d clinical data registry, we believe that an eligible prof essional or group practice would not purchase a qualified registry, direct EHR product, EHR data submission vendor product, or qualified clin ical data registry solely for the purpose of reporting PQRS quality m easures. Therefore, we have not included the cost of purchasing a qualified registry, direct EHR, EHR data submission vendor product, or qualified clinical data regist ry in our burden estimates.

### CMS-1600-FC 1299

Unlike eligible professionals who choose to re port individually, we noted that eligible professionals choosing to participate as part of a group practice under th e GPRO must indicate their intent to participate in the PQRS as a gr oup practice. The total burden for group practices who submit PQRS quality measures data via th e proposed GPRO web-interface would be the time and effort associated with submitting this data. To submit quality measures data for the PQRS, a group practice would need to (1) be selected to particip ate in the PQRS GPRO and (2) report quality measures data. W ith respect to the administrative duties for being selected to participate in the PQRS as a GPRO, we believe it would take approxima tely 6 hours – including 2 hours to decide to participate in the PQRS as a GPRO, 2 hours to self-nominate, and 2 hours to undergo the vetting process with CM S officials – for a group practice to be selected to participate in the PQRS GPRO for the applicable year. Ther efore, we estimated that the cost of undergoing the GPRO selection process woul d be ($16/hour x 6 hours) $96. W ith respect to reporting, the total reporting burden is the time and effort associated with the group practice submitting the quality measures data (that is, completed th e data collection interf ace). Based on burden estimates for the PGP demonstration, which uses the same data submission methods, we estimated the burden associated with a group pr actice completing the data collection interface would be approximately 79 hours. Therefore, we estimated that the report cost for a group practice to submit PQRS quality measures da ta for the proposed reporting options in an applicable year would be ($40/hour x 79 hours) $3,160. Aside from the burden of eligible professi onals and group practices participating in the PQRS, we believe that vendors of registries, qualifie d clinical data registries, direct EHR products, and EHR data submission vendor products incur costs associated with participating in the PQRS. Please note that we finalized requirem ents for a new reporting mechanism in this CY

### CMS-1600-FC 1300

2014 PFS final rule with comment peri od – the qualified clin ical data registry. For purposes of these burden estimates, we believe that, at least in its initial stage, vendors of a qualified clinical data registry would have burden estimates similar to traditional registries, as we believe many of the vendors seeking to become qualified as a clini cal data registry in the PQRS will be existing qualified registries. With respect to qualified registries and qualif ied clinical data registries, the total burden for qualified registries who submit PQRS Quality Measures Data would be the time and effort associated with submitting this data. To submit quality measures data for the proposed program years for PQRS, a registry would need to (1) be come qualified for the a pplicable year and (2) report quality measures data on behalf of its eligible prof essionals. With respect to administrative duties related to the qualification pr ocess for both traditional registries and clinical data registries, we estimated that it will take a total of 10 hours – including 1 hour to complete the self-nomination statement, 2 hours to interv iew with CMS, 2 hours to calculate numerators,denominators, and measure results for each measure the registry wishes to report using a CMSprovided measure flow, and 5 hours to complete an XML submission – to become qualified to report PQRS quality measures data. Therefore, we estimated that it would cost a traditional registry and clinical data re gistry ($16.00/hour x 10 hours) $160 to become qualified to submit PQRS quality measures data on behalf of its eligible professionals. With respect to the reporting of quality measures data, we believe the burden associated with reporting is the time and effort associated with the registry calculating quality measures results from the data submitted to the registry by its eligible professionals, submitting numerator and denominator data on quality measures, and cal culating these measure results. We believe, however, that registries already pe rform these functions for its elig ible professionals irrespective

### CMS-1600-FC 1301

of participating in the PQRS. Th erefore, we believe there would be little to no additional burden associated with reporting PQRS quality measures data. Whether there is any additional reporting burden will vary with each regi stry, depending on the registry’s level of savvy with submitting quality measures data for the PQRS. With respect to EHR products, the total bu rden for direct EHR products and EHR data submission vendors who submit PQRS Quality Meas ures Data would be the time and effort associated with submitting this data. To submit quality measures data for a program year under the PQRS, a direct EHR product or EHR data s ubmission vendor would need to report quality measures data on behalf of its eligible profession als. Please note that we do not require direct EHR products and EHR data submission vendors to become qualified to submit PQRS quality

measures data. In addition to the GPRO web interface, plea se note that we have established a new reporting mechanism that would be available to group practices compri sed of 25-99 eligible professionals: the certified survey vendor. With respect to using a certified survey vendor, we

believe there would be little to no burden a ssociated for a group pr actice to report the CG CAHPS survey data to CMS, because the sele cted reporting mechanism submitted the quality measures data for the group practice. Although there may be start-up costs associated with purchasing a certified survey vendor, we believe that a group practice would not purchase a certified survey vendor solely for the purpose of reporting the CG CAHPS survey for the PQRS. Therefore, we have not included the cost of purchasing a certified survey vendor in our burden

estimates.

### CMS-1600-FC 1302

TABLE 95: Estimated Costs for Reporting PQ RS Quality Measures Data per Eligible Professional

Estimated Hours Estimated Cases Number of Measures Hourly Rate Total Cost Individual Eligible Professional (EP): Preparation 5.0 1 N/A $16 $80

Individual EP: Claims 1.8 6 9 $40 $3,888 Individual EP: Registry N/A 1 N/A N/A Minimal Individual EP: EHR N/ A 1 N/A N/A MinimalGroup Practice: SelfNomination 6.0 1 N/A $16 $96 Group Practice: Reporting 79 1 N/A $40 $3,160 TABLE 96: Estimated Costs per Vendor to Participate in the PQRS Estimated Hours Hourly Rate Total Cost Registry: Self-Nomination 10 $16 $160

10. Medicare EHR Incentive Program Please note that the requirements for meeting the clinical quality measures (CQM) component of achieving meaningful use for the EHR Incentive Program in 2014 were

established in a standalone final rule published on September 4, 2012 (77 FR 53968). The proposals contained in this CY 2014 PFS final rule with comment period merely propose alternative methods to report CQ Ms to meet the CQM component of achieving meaningful use for the EHR Incentive Program in 2014. We beli eve any impacts these proposals would have are absorbed in the impacts discussion published in the EHR Incentive Program final rule published on September 4, 2012. 11. Medicare Shared Savings Program Please note that the requirements for pa rticipating in the Medicare Shared Saving Program and the impacts of these requirements were established in the final rule for the Medicare Shared Savings Program that appeared in the Federal Register on November 2, 2011

### CMS-1600-FC 1303

(76 FR 67962). The proposals for the Medicare Shared Savings Program set forth in the CY 2014 final rule with comment period expand th e incorporation of reporting requirements and incentive payments related to PQRS under sec tion 1848 to include reporti ng requirements related to the payment adjustment. Since ACO participan ts and ACO provider/suppliers will not have to report PQRS separately to avoid the payment ad justment, this reduces the quality reporting burden for ACO participants participating in the Shared Savings Program. There is no impact for the additional proposals related to requirement s for setting benchmarks or for scoring the

CAHPS measure modules. 12. Physician Value-Based Payment Modifier an d the Physician Feedback Reporting Program The changes to the Physician Feedback Program in section III.K. of this final rule with comment period would not impact CY 2014 phys ician payments under the Physician Fee Schedule. We anticipate that as we approach implementation of the value modifier, physicians will increasingly participate in the Physicia n Quality Reporting System to determine and

understand how the value modifier could affect their payments. 13. Existing Standards for E-prescribing under Medicare Part D and Identification

This section of the final rule with comment period imposes no new requirements because use of the official Part D e-prescreening standards; NCPDP SCRI PT 10.6, Formulary and Benefit 3.0 are voluntary, and as such, it will not have a significant economic impact on a

substantial number of small entitie s, small rural hospitals or state, local, or tribal governments or on the private sector. 14. Chiropractic Services Demonstration

As discussed in section III.M. of this fina l rule with comment period, we are continuing the recoupment of the $50 million in expenditures from this demonstr ation in order to satisfy the

### CMS-1600-FC 1304

BN requirement in section 651(f)(1)(B) of the MMA. We initiated this recoupment in CY 2010 and this will be the fifth and final year. As discussed in the CY 2010 PFS final rule with comment period, we finalized a policy to rec oup $10 million each year through adjustments to payments under the PFS for chiropractic CPT code s in CYs 2010 through 2014. For each year of this recoupment, we have provided OACT’s pr ojected chiropractic expenditures based on previous year’s data. Although OACT’s projections have include d the statutory reductions to physician payments, the statute was amended in each year to avoid these reductions. As a result, Medicare expenditures for chirop ractic services during the rec oupment were higher than the OACT projections. Chiropractic services expend itures during the recoupment period have been as follows: $540 million in 2010; $520 million in 2011; and $580 million in 2012. In total, CMS recouped $32.8 million over the years of 2010, 2011 and 2012. OACT now projects chiropractic expenditures to be approximatel y $580 million in 2013. A 2 percent recoupment percentage for chiropractic services would result in approximately $11.6 million in 2013. For the years 2010 through 2013, CMS would have recouped approximately $44.4 million of the $50 million required for budget neutrality. CMS plans to recoup the remaining funds , approximately $5.6 million, and will reduce chiropractic CPT codes (CPT codes 98940, 98941, and 98942) by the appropriate percentage.

G. Alternatives Considered This final rule with comment period cont ains a range of policies, including some provisions related to specific st atutory provisions. The preceding preamble provides descriptions of the statutory provisions that are addressed, identifie s those policies when discretion has been exercised, presents rationale for our final policie s and, where relevant, al ternatives that were

considered.

### CMS-1600-FC 1305

H. Impact on Beneficiaries There are a number of changes in this final rule with comment period that would have an

effect on beneficiaries. In general, we believe that many of the changes, including the refinements of the PQRS with its focus on m easuring, submitting, and analyzing quality data; establishing the basis for the value-based paym ent modifier to adjust physician payment beginning in CY 2015; improved accu racy in payment through revi sions to the inputs used to calculate payments under the PFS; and revisions to payment for Part B drugs will have a positive impact and improve the quality and value of care provided to Medicare beneficiaries. Most of the aforementioned policy changes could result in a change in beneficiary liability as relates to coinsura nce (which is 20 percent of the fee schedule amount if applicable for the particular provision after the beneficiary has met the deductible). To illustrate this point, as shown in Table 94, the CY 2013 national paym ent amount in the nonfaci lity setting for CPT code 99203 (Office/outpatient visit, new) is $108.05, which means th at in CY 2013 a beneficiary would be responsible for 20 per cent of this amount, or $21.61. Ba sed on this final rule with comment period, using the current (CY 2013) CF of 34.0376, adjusted to 35.6446 to include budget neutrality, the CY 2014 national payment am ount in the nonfacility setting for CPT code 99203, as shown in Table 94, is $107.95, which means that, in CY 2014, the beneficiary

coinsurance for this service would be $21.59. I. Accounting Statement As required by OMB Circul ar A-4 (available at http://www.whitehouse.gov/om b/circulars/a004/a-4.pdf ), in Table 97 (Accounting Statement), we have prepared an accounting statement showi ng the estimated expenditures associated with this final rule with comment period. This esti mate includes the CY 2014 in curred benefit impact

### CMS-1600-FC 1306

associated with the estimated CY 2014 PFS c onversion factor update based on the FY 2014 President's Budget baseline. TABLE 97: Accounting Statement: Cla ssification of Estimated Expenditures CATEGORY TRANSFERS CY 2014 Annualized Monetized Tran sfers Estimated decrease in expenditures of $18.8 billion for PFS conversion factor update. From Whom To Whom? Federal Government to physicians, other p ractitioners and providers and suppliers who receive p ayment under Medicare. CY 2014 Annualized Monetized Transfers Estim ated increase in payment of $286 million. From Whom To Whom? Federal Government to eligible professionals who satisfactorily participate in the Physician Quality Reporting System (PQRS). CY 2014 Annualized Monetized Transfers Estimat ed decrease in expe nditures of $50 million for liability for overpayments to or on behalf of individuals including payments to providers or other p ersons. From Whom To Whom? Federal Government to physicians, other p ractitioners and providers and suppliers who receive p ayment under Medicare. TABLE 98: Accounting Statement: Classifi cation of Estimated Costs, Transfer, and Savings Category Transfer CY 2014 Annualized Monetized

Transfers of beneficiary cost coinsurance. -$29 million

From Whom to Whom? Benefi ciaries to Physicians and Nonphysician Practitioners Category Cost CY 2014 Annualized Monetized Cost to eligible professionals of Participating in the PQRS Program $66.6 million

J. Conclusion The analysis in the previous sections, toge ther with the remainder of this preamble, provides an initial “Regulatory Flexibility Analysis .” The previous analysis, together with the

### CMS-1600-FC 1307

preceding portion of this preamble, pr ovides a Regulatory Impact Analysis. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.

### CMS-1600-FC 1308

List of Subjects

42 CFR Part 405 Administrative practice and pr ocedure, Health facilities, Health professions, Kidney diseases, Medical devices, Medi care, Reporting and recordkeeping requirements, Rural areas, Xrays. 42 CFR Part 410 Health facilities, Health pr ofessions, Kidney diseases, Labor atories, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays.

42 CFR Part 411 Kidney diseases, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 414 Administrative practice and pr ocedure, Health facilities, Health professions, Kidney diseases, Medicare, Reporting a nd recordkeeping requirements.

42 CFR Part 423 Administrative practice and pr ocedure, Emergency medical se rvices, Health facilities, Health maintenance organizations (HMO), Hea lth professionals, Incor poration by Reference, Medicare, Penalties, Privacy, Reporti ng and recordkeeping requirements.

42 CFR Part 425 Administrative practice and pro cedure, Health facilities, H ealth professions, Medicare, Reporting and recordkeeping requirements.

### CMS-1600-FC 1309

For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV as set forth below:

PART 405--FEDERAL HEALTH INSU RANCE FOR THE AG ED AND DISABLED 1. The authority citation for part 40 5 continues to read as follows: Authority: Secs. 205(a), 1102, 1861, 1862(a), 1862(m), 1869, 1871, 1874, 1881, and 1886(k) of the Social Security Act (42 U.S.C. 405(a), 1302, 1395x, 1395y(a), 1395y(m), 1395ff, 1395hh, 1395kk, 1395rr and 1395ww(k)), and sec. 353 of the Public Health Service Act (42 U.S.C. 263a). 2. Section 405.201 is amended by: A. Revising paragraph (a)(2). B. Adding paragraph (a)(3). C. Revising paragraph (b).

The revisions and addition read as follows: §405.201 Scope of subpart and definitions. (a) * * * (2) CMS may consider for Medicare covera ge certain devices with an FDA-approved investigational device exemption (IDE) that have been categorized as Category B (Nonexperimental/investigational) device. (3) CMS identifies criteria for coverage of items and services furn ished in IDE studies. (b) Definitions

. As used in this subpart—

### CMS-1600-FC 1310

Category A (Experimental) device refers to a device for which “absolute risk” of the device type has not been establishe d (that is, initial questions of sa fety and effectiveness have not been resolved) and the FDA is unsure whether the device type can be safe and effective. Category B (Nonexperime ntal/investigational) device refers to a device for which the incremental risk is the primary risk in question (that is, initial questions of safety and effectiveness of that device type have been resolved), or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained FDA prem arket approval or clearance for that device type. 

### ClinicalTrials.gov refers to the National Institutes of Health’s National Library of Medicine’s online registry and results database of publicly an d privately supported clinical studies of human participan ts conducted around the world.

Contractors refers to Medicare Administrative Contra ctors and other enti ties that contract with CMS to review and adjudicate claims fo r Medicare payment of items and services. Investigational device exemption (IDE) refers to an FDA-approved IDE application that permits a device, which would otherwise be subj ect to marketing approval or clearance, to be shipped lawfully for the purpose of conducting a clinical study in accordance with 21 U.S.C. 360j(g) and 21 CFR part 812.

Routine care items and services refers to items and services that are otherwise generally available to Medicare beneficiaries (that is, a benef it category exists, it is not statutorily excluded, and there is no national noncoverage decision) that are fu rnished during a clinical study and that would be otherwise furnished even if the beneficiary were not enrolled in a clinical study. 

### 3. Section 405.203 is amended by revising paragr aphs (a)(1) and (2) an d (b) to read as

follows: §405.203 FDA categorization of investigational devices. (a) * * *

### CMS-1600-FC 1311

(1) Category A (Experimental) devices. (2) Category B (Nonexperimental/investigational) devices. (b) The FDA notifies CMS, when it notifies th e sponsor, that the device is categorized by FDA as Category A (Experimental) or Category B (Nonexperimental).

* * * * * 

### 4. Section 405.205 is amended by revising the section heading and paragraph (a)(1) to

read as follows: §405.205 Coverage of a Category B (Nonexp erimental/investigational) device. (a) * * * (1) The FDA notifies CMS, when it notifies th e sponsor, that the device is categorized by FDA as Category B (Nonexperime ntal/investigational).

* * * * * 5. Section 405.207 is amended by revising paragraphs (b)(2) and (3) to read as follows: §405. 

### 207 Services related to a non-covered device.

* * * * * (b) * * * (2) Routine care items and services relate d to Category A (Experimental) devices as defined in § 405.201(b), and furnished in conjuncti on with FDA-approved c linical studies that meet the coverage requirements in §405.211. (3) Routine care items and serv ices related to Category B (Nonexperimental/investigationa l) devices as defined in § 405.201(b), and furnished in conjunction with FDA-approved cl inical studies that meet th e coverage requirements in §

405.211.

6. Section 405.209 is revise d to read as follows:

### CMS-1600-FC 1312

§405.209 Payment for a Category B (Nonexperi mental/investigational) device. Payment under Medicare for a Category B (None xperimental/investigational) device is based on, and may not exceed, the amount that would have been paid for a currently used device serving the same medical purpose that has been approved or cleared for marketing by the FDA.

7. Section 405.211 is revise d to read as follows: §405.211 Coverage of items and services in FDA-approved IDE studies. (a) Coverage of routine care items and serv ices for Category A (Experimental) devices

. Medicare covers routine care items and servic es furnished in an FDA-approved Category A (Experimental) IDE study if CMS (or its design ated entity) determines that the Medicare coverage IDE study criteria in § 405.212 are met. (b) Coverage of Category B (Nonexperimental /investigational) IDE devices and routine

care items and services. Medicare may make payment for a Category B (Nonexperimental/investigational) IDE device and routine care item s and services furnished in an FDA-approved Category B (Nonexperimental/i nvestigational) IDE study if CMS (or its designated entity) determines prior to the submission of the first related claim that the Medicare coverage IDE study criteri a in §405.212 are met. (c) CMS (or its designated entity) must review the following to determine if the Medicare coverage IDE study criteria in § 405.212 are met for purposes of cove rage of items and services described in paragraphs (a) a nd (b) of this section: (1) FDA approval letter of the IDE. (2) IDE study protocol. (3) IRB approval letter. 

### (4) NCT number. (5) Supporting materials, as needed.

### CMS-1600-FC 1313

(d) Notification . A listing of all CMS-approved Ca tegory A (Experimental) IDE studies and Category B (Nonexperimental/investigationa l) IDE studies shall be posted on the CMS website and published in the Federal Register

. 8. Section 405.212 is added to read as follows: §405.212 Medicare Coverage IDE study criteria. (a) For Medicare coverage of items and services described in § 405.211, a Category A (Experimental) or Category B (Nonexperimental/inve stigational) IDE study must meet all of the following criteria: (1) The principal purpos e of the study is to test whet her the device improves health outcomes of appropriately selected patients. (2) The rationale for the study is well suppor ted by available scientific and medical information, or it is intended to clarify or esta blish the health outcomes of interventions already

in common clinical use. (3) The study results are not anticipated to unjustifiably duplicat e existing knowledge. (4) The study design is methodologically appr opriate and the antic ipated number of enrolled subjects is adequate to confidently answ er the research question(s) being asked in the study. (5) The study is sponsored by an organizati on or individual capable of successfully completing the study. (6) The study is in compliance with all applicable Federal regulations concerning the protection of human subjects found at 21 CF R parts 50, 56, and 812 and 45 CFR part 46. (7) Where appropriate, the study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Studi es of all medical technologies measuring

### CMS-1600-FC 1314

therapeutic outcomes as one of the objectives ma y be exempt from this criterion only if the disease or condition being studied is life threatening and the patient has no other viable treatment options. (8) The study is registered with the Nationa l Institutes of Health’s National Library of Medicine’s ClinicalTrials.gov. (9) The study protocol describes the method and timing of release of results on all prespecified outcomes, including re lease of negative outcomes and that the release should be hastened if the study is terminated early. (10) The study protocol must describe how Medicare benefici aries may be affected by the device under investigation, and how the study results are or are not expected to be generalizable to the Medicare beneficiary popul ation. Generalizability to popul ations eligible for Medicare due to age, disability, or other eligibility status must be explicitly described. (b) [Reserved] 9. Section 405.213 is amended by revising pa ragraph (a)(1) to read as follows: §405.213 Re-evaluation of a device categorization. (a) * * * (1) Any sponsor that does not agree with an FDA decision that categorizes its device as Category A (experimental) may request re-eva luation of the categorization decision.

* * * * * 10. Section 405.350 is amended by revising pa ragraph (c) to read as follows: §405.350 Individual's liability for payments made to providers and other persons for items

and services furnished the individual.

* * * * *

### CMS-1600-FC 1315

(c) For purposes of paragraph (a)(2) of this sectio n, a provider of services or other person must, in the absence of evidence to the contra ry, be deemed to be without fault if the determination of the carrier, the intermediary, or the Centers for Medicare & Medicaid Services that more than the correct amount was paid was made subsequent to the fifth year following the year in which notice was sent to such i ndividual that such amount had been paid. 11. Section 405.355 is amended by revising pa ragraph (b) to read as follows: §405.355 Waiver of adjustment or recovery.

* * * * * (b) Adjustment or recovery of an incorrect payment (or only such part of an incorrect payment as may be determined to be inconsistent with the purposes of Title XVIII of the Act) against an individual who is without fault w ill be deemed to be against equity and good conscience if the incorrect payment was made fo r items and services that are not payable under section 1862(a)(1) or (a)(9) of the Act and if the determinatio n that such payment was incorrect was made subsequent to the fifth year following the year in which notice of such payment was

sent to such individual. 12. Section 405.2413 is amended by— A. Redesignating paragraphs (a)(4) and (5) as paragraphs (a)(5) and (6), respectively. B. Adding new paragraph (a)(4). C. Revising newly redesi gnated paragraph (a)(5).

The revision and addition reads as follows: §405.2413 Services and supplies incident to a physician's services. (a) * * * (4) Services and supplies must be furnished in accordance with a pplicable State law;

### CMS-1600-FC 1316

(5) Furnished under the direct s upervision of a physician; and

* * * * * 13. Section 405.2415 is amended by— A. Redesignating paragraphs (a)(4) and (5) as paragraphs (a)(5) and (6), respectively. B. Adding new paragraph (a)(4). C. Revising newly redesi gnated paragraph (a)(5). D. Revising paragraph (b).

The revision and addition reads as follows: §405.2415 Services and supplies incident to nur se practitioner and physician assistant

services. (a) * * * (4) Services and supplies must be furnished in accordance with a pplicable State law; (5) Furnished under the direct supervision of a nurse practitioner, physician assistant, nurse midwife, specialized nurse practitioner or a physician; and

* * * * * (b) The direct supervis ion requirement is met in the case of a nurse practitioner, physician assistant, nurse midwife, or specialized nurse practitioner only if such a person is permitted to supervise such services unde r the written policies governi ng the rural health clinic.

* * * * * 14. Section 405.2452 is amended by— A. Redesignating paragraphs (a)(4) and (5) as paragraphs (a)(5) and (6), respectively. B. Adding new paragraph (a)(4). C. Revising newly redesi gnated paragraph (a)(5).

### CMS-1600-FC 1317

D. Revising paragraph (b).

The revision and addition reads as follows: §405.2452 Services and supplies incident to clinical psychologist and clin ical social worker

services. (a) * * * (4) Services and supplies must be furnished in accordance with a pplicable State law; (5) Furnished under the direct supervision of a clinical psychologist, clinical social worker or physician; and

* * * * * (b) The direct supervis ion requirement in paragraph (a)(5) of this section is met only if the clinical psychologist or clinical social wo rker is permitted to supervise such services under the written policies governing the federally qualified health center. PART 410—SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS 15. The authority citation for part 410 continues to read as follows: Authority: Secs. 1102, 1834, 1871, 1881, and 1893 of the Social Security Act (42 U.S.C. 1302. 1395m, 1395hh, and 1395ddd). §410.19 [Amended] 16. In §410.19(a) amend the definition of “elig ible beneficiary” by removing paragraph (1) and redesignating paragraphs (2) and (3) as paragraphs (1) and (2), respectively. 17. Section 410.26 is amended by— A. Revising paragraph (a)(1). B. Redesignating paragraph (b)(7) and (8) as paragraph (b)(8) a nd (9), respectively. C. Adding new paragraph (b)(7).

### CMS-1600-FC 1318

The revision and addition reads as follows: §410.26 Services and supplies incident to a physici an’s professional services: Conditions. (a) * * * (1) Auxiliary personnel means any individual who is ac ting under the supervision of a physician (or other practitioner), regardless of whether the individual is an employee, leased employee, or independent contractor of the physic ian (or other practitioner) or of the same entity that employs or contracts with the physician (or other practitioner) a nd meets any applicable requirements to provide the serv ices, including licensure, impo sed by the State in which the services are being furnished.

* * * * * (b) * * * (7) Services and supplies must be furnished in accordance with applicable State law.

* * * * * 18. Section 410.37 is amended by revising pa ragraph (b) to read as follows: §410.37 Colorectal cancer screening tests: Conditions for and limitations on coverage.

* * * * * (b) Condition for coverage of screening fecal-occult blood tests . Medicare Part B pays for a screening fecal-occult blood test if it is ordered in wri ting by the beneficiary’s attending physician, physician assistant, nurse practitioner, or clin ical nurse specialist.

* * * * * 19. Section 410.59 is amended by— A. Adding paragraph (e)(1)(iv). B. Revising paragraph (e)(2)(iv).

### CMS-1600-FC 1319

C. Adding paragraph (e)(2)(v).

The revision and additions reads as follows: §410.59 Outpatient occupational therapy services: Conditions.

* * * * * (e) * * * (1) * * * (iv) Outpatient occupational therapy serv ices furnished by a CAH directly or under arrangements must be counted towards the annua l limitation on incurred expenses as if such services were paid under sect ion 1834(k)(1)(b) of the Act. (2)* * * (iv) Outpatient occupational therapy services furnished by a nurse practitioner, clinical nurse specialist, or physician assistant or incident to their services; and (v) Outpatient occupational therapy servic es furnished by a CAH directly or under arrangements.

* * * * * 20. Section 410.60 is amended by— A. Adding paragraph (e)(1)(iv). B. Revising paragraph (e)(2)(v). C. Adding paragraph (e)(2)(vi). D. In paragraph (e)(3), removing the phrase “or CAH”.

The additions and revision read as follows: §410.60 Outpatient physical therapy services: Conditions.

* * * * *

### CMS-1600-FC 1320

(e)* * * (1)* * * (iv) Outpatient physical ther apy and speech-language pathology services furnished by a CAH directly or under arrangements must be co unted towards the annual limitation on incurred expenses as if such services were pa id under section 1834(k)(1)(b) of the Act. (2) * * * (v) Outpatient physical therapy and speech-l anguage pathology services furnished by a nurse practitioner, clinical nurse specialist, or physician assistant or incident to their services;

and (vi) Outpatient physical therapy and speech-l anguage pathology services furnished by a CAH directly or under arrangements.

* * * * * 21. Section 410.71 is amended by revising pa ragraph (a)(2) to read as follows: §410.71 Clinical psychologist services and se rvices and supplies incident to clinical psychologist services. (a) * * * (2) Medicare Part B covers services and supplie s incident to the services of a clinical psychologist if the requir ements of §410.26 are met.

* * * * * 22. Section 410.74 is amended by revising pa ragraph (b) to read as follows: §410.74 Physician assistants’ services.

* * * * * (b) Services and supplies furnished incide nt to a physician assistant’s services. Medicare

### CMS-1600-FC 1321

Part B covers services and supp lies incident to the services of a physician assistant if the requirements of §410.26 are met.

* * * * * 23. Section 410.75 is amended by revising paragraph (d) to read as follows: §410.75 Nurse practitioners’ services.

* * * * * (d) Services and supplies incident to a nurse practitioners’ services . Medicare Part B covers services and supplies incide nt to the services of a nurse pr actitioner if the requirements of §410.26 are met.

* * * * * 24. Section 410.76 is amended by revising para graph (d) to read as follows: §410.76 Clinical nurse sp ecialists’ services.

* * * * * (d) Services and supplies furnished incident to clinical nurse specialists’ services

. Medicare Part B covers services and supplies incident to the servic es of a clinical nurse specialist if the requirements of §410.26 are met.

* * * * * 25. Section 410.77 is amended by revising pa ragraph (c) to read as follows: §410.77 Certified nurse-midwives’ services: Qualifications and conditions.

* * * * * (c) Incident to services: Basic rule. Medicare Part B cove rs services and supplies

incident to the services of a certified nurse-midwife if the requirements of § 410.26 are met.

* * * * *

### CMS-1600-FC 1322

26. Section 410.78 is amended by revising paragr aph (b) introductory text and paragraph (b)(4) to read as follows: § 410.78 Telehealth services.

* * * * * (b) General rule

. Medicare Part B pays for office or other outpatient visits, subsequent hospital care services (with the limitation of one telehealth visit every three days by the patient’s admitting physician or practitioner), subsequent nurs ing facility care services (not including the Federally-mandated periodic visits under § 483.40(c) of this chap ter and with the limitation of one telehealth visit every 30 days by the patient’s admitting physician or nonphysician practitioner), professional consultations, ps ychiatric diagnostic interview examination, neurobehavioral status exam, individual psyc hotherapy, pharmacologic management, end-stage

renal disease-related services included in the monthly capitation payment (except for one ‘‘hands on’’ visit per month to examine the access site), individual and group medical nutrition therapy services, individual and group kidne y disease education services, i ndividual and group diabetes self-management training services (except for on e hour of ‘‘hands on’’ serv ices to be furnished in the initial year training pe riod to ensure effec tive injection training ), individual and group

health and behavior assessment and interventi on services, smoking cessa tion services, alcohol

and/or substance abuse and brief intervention services, screening and behavioral counseling interventions in primary care to reduce alcoho l misuse, screening for depression in adults, screening for sexually transmitted infections (S TIs) and high intensity behavioral counseling (HIBC) to prevent STIs, intensive behavioral therapy for cardiovascular disease, behavioral counseling for obesity, and transitional care ma nagement services furnished by an interactive telecommunications system if th e following conditions are met:

### CMS-1600-FC 1323

* * * * * (4) Originating sites must be: (i) Located in a health professional shortage area (as defined unde r section 332(a)(1)(A)

of the Public Health Service Act (42 U.S.C. 254e(a)(1)(A)) th at is either outside of a Metropolitan Statistical Area (M SA) as of December 31st of th e preceding calendar year or

within a rural census tract of an MSA as determ ined by the Office of Rural Health Policy of the

Health Resources and Services Administration as of December 31st of the preceding calendar

year, or (ii) Located in a county that is not included in a Metropolitan Statistical Area as defined in section 1886(d)(2)(D) of the Act as of December 31st of the preceding year, or (iii) An entity participating in a Federal tele medicine demonstration project that has been approved by, or receive funding from, the Secret ary as of December 31, 2000, regardless of its geographic location.

* * * * *

PART 411—EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE

PAYMENT 27. The authority citation for part 411 continues to read as follows: Authority: Secs. 1102, 1860D-1 through 1860D-42, 1871, and 1877 of the Social Security Act (42 U.S.C. 1302, 1395w-101 through 1395w-152, 1395hh, and 1395nn). 28. Section 411.15 is amended by revising paragra phs (o)(1) and (2) to read as follows: §411.15 Particular services excluded from coverage.

* * * * * (o) * * *

### CMS-1600-FC 1324

(1) Categorized by the FDA as a Category B (N onexperimental/investigational) device as defined in §405.201(b) of the chapter; and (2) Furnished in accordance with the coverage requirements in §405.211(b).

* * * * *

PART 414-PAYMENT FOR PART B MEDI CAL AND OTHER HEALTH SERVICES 29. The authority citation for part 414 continues to read as follows: Authority: Secs. 1102, 1871, and 1881(b)(l) of the So cial Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)). 30. Section 414.65 is amended by revising paragraph (a)(1) to read as follows: §414.65 Payment for telehealth services. (a) * * * (1) The Medicare payment amount for office or other outpatient visits, subsequent hospital care services (with the limitation of one telehealth visi t every 3 days by the patient’s admitting physician or practitioner), subsequent nu rsing facility care serv ices (with the limitation of one telehealth visit every 30 days by the patient’s admitting physician or nonphysician practitioner), professional consultations, ps ychiatric diagnostic interview examination, neurobehavioral status exam, individual psyc hotherapy, pharmacologic management, end-stage

renal disease-related services included in the monthly capitation payment (except for one “hands on” visit per month to examine the access site), individual and group medical nutrition therapy services, individual and group kidne y disease education services, i ndividual and group diabetes self-management training services (except for one hour of “hands on” services to be furnished in the initial year training period to ensure effective injection training), individual and group health and behavior assessment and intervention, smoking cessation services, alcohol and/or substance

### CMS-1600-FC 1325

abuse and brief intervention services, screeni ng and behavioral counseling interventions in primary care to reduce alcohol misuse, screening for depression in adults, screening for sexually transmitted infections (STIs) and high intensity behavioral counseling (HIBC) to prevent STIs, intensive behavioral therapy for cardiovascular disease, behavioral counseling for obesity, and transitional care management services furnished vi a an interactive telecommunications system is equal to the current fee schedule amount appli cable for the service of the physician or practitioner. (i) Emergency department or initia l inpatient telehealth consultations

. The Medicare payment amount for emergency department or initia l inpatient telehealth consultations furnished

via an interactive tel ecommunications system is equal to the current fee schedule amount applicable to initial ho spital care provided by a phys ician or practitioner. (ii) Follow-up inpatient telehealth consultations

. The Medicare payment amount for follow-up inpatient telehealth consultations furnished via an interactive telecommunications system is equal to the current fee schedule amount applicable to subsequent hospital care provided by a physician or practitioner.

* * * * *

31. Section 414.90 is revised to read as follows: §414.90 Physician Quality Reporting System (PQRS). (a) Basis and scope . This section implements the following provisions of the Act: (1) 1848(a)--Payment Based on Fee Schedule. (2) 1848(k)--Quality Reporting System. (3) 1848(m)--Incentive Payments for Quality Reporting. (b) Definitions . As used in this section, unless otherwise indicated--

### CMS-1600-FC 1326

Administrative claims means a reporting mechanism under which an eligible professional or group practice uses claims to report data on PQRS quality measures. Under this reporting mechanism, CMS analyzes claims data to determ ine which measures an eligible professional or group practice reports. Certified survey vendor means a vendor that is certifie d by CMS for a particular program year to transmit survey measures data to CMS. Covered professional services means services for which payment is made under, or is based on, the Medicare physician fee schedule as provided under secti on 1848(k)(3) of the Act and which are furnished by an eligible professional.

Direct electronic health record (EHR) product means an electronic health record vendor’s product and version that submits data on PQRS measures directly to CMS. Electronic health record (EHR) data submission vendor product means an entity that receives and transmits data on PQRS m easures from an EHR product to CMS. Eligible professional means any of the following: (i) A physician. (ii) A practitioner described in section 1842(b)(18)(C ) of the Act. (iii) A physical or occupational therapist or a qualified speech-la nguage pathologist. (iv) A qualified audiologist (as define d in section 1861(ll)(3)(B) of the Act). Group practice means a physician group practice that is defined by a TIN, with 2 or more individual eligible professionals (or, as identified by NPIs) that has reassigned thei r billing rights

to the TIN. Group practice reporting op tion (GPRO) web interface means a web product developed by CMS that is used by group practices that are selected to participate in the group practice

### CMS-1600-FC 1327

reporting option (GPRO) to submit data on PQRS quality measures.

Maintenance of Cer tification Program means a continuous assessment program, such as qualified American Board of Medical Specialties Maintenance of Certification Program or an equivalent program (as determined by the Secr etary), that advances quality and the lifelong learning and self-assessment of board certi fied specialty physicians by focusing on the competencies of patient care, medical knowledge , practice-based learning, interpersonal and communication skills, and professionalism. Such a program must include the following: (i) The program requires the physician to main tain a valid unrestri cted license in the

United States. (ii) The program requires a physician to par ticipate in educationa l and self-assessment programs that require an assessment of what was learned. (iii) The program requires a physician to de monstrate, through a formalized secure examination, that the physician has the fundame ntal diagnostic skills, medical knowledge, and clinical judgment to provide quality care in their respective specialty. (iv) The program requires successful co mpletion of a qualified maintenance of certification program practice assessment.

Maintenance of Certificati on Program Practice Assessment means an assessment of a physician’s practice that-- (i) Includes an initial assessment of an eligib le professional’s practice that is designed to demonstrate the physician’s use of evidence-based medicine. (ii) Includes a survey of pa tient experience with care. (iii) Requires a physician to implement a qua lity improvement intervention to address a practice weakness identified in the initial assessment under paragraph (h) of this section and then

### CMS-1600-FC 1328

to remeasure to assess performance im provement after such intervention. Measures group means a subset of four or more PQ RS measures that have a particular

clinical condition or focus in common. The deno minator definition and coding of the measures group identifies the condition or focus that is sh ared across the measures within a particular

measures group. Physician Quality Reporting System (PQRS) means the physician reporting system under section 1848(k) of the Act for the reporting by eligible professionals of data on quality measures and the incentive payment associated w ith this physician reporting system.

Performance rate means the percentage of a defined population who receives a particular process of care or achieve a particular outcome for a particular quality measure. Qualified clinical data registry means a CMS-approved entity that has self-nominated and successfully completed a qualification process that collects medical and/or clinical data for the purpose of patient and disease tracking to foster improvement in the quality of care provided to patients. A qualified clinical data registry must perf orm the following functions: (i) Submit quality measures data or results to CMS for purposes of demonstrating that, for a reporting period, its eligible professionals have satisfactor ily participated in PQRS. A qualified clinical data registry must have in place mechanisms for the transparency of data elements and specifications, risk models, and measures. (ii) Submit to CMS, for purposes of dem onstrating satisfactory participation, quality measures data on multiple payers, not just Medicare patients (iii) Provide timely feedback, at least four tim es a year, on the measures at the individual participant level for which the qualified clinical data registry reports on the eligible professional’s behalf for purposes of the indi vidual eligible prof essional’s satisfactory

### CMS-1600-FC 1329

participation in the clinical quality data registry. (iv) Possess benchmarking capacity that measures the quality of care an eligible professional provides with other eligible professionals performing the same or similar functions. Qualified registry means a medical registry or a ma intenance of certification program operated by a specialty body of the American Board of Medical Specialties that, with respect to a particular program year, has self-nominated a nd successfully completed a vetting process (as specified by CMS) to demonstrate its complia nce with the PQRS qualification requirements specified by CMS for that program year. The registry may act as a data submission vendor, which has the requisite legal auth ority to provide PQRS data (as specified by CMS) on behalf of an eligible professional to CMS. If CMS fi nds that a qualified registry submits grossly inaccurate data for reporting periods occurring in a particular year, CMS reserves the right to disqualify a registry for reporting peri ods occurring in the subsequent year. Reporting rate means the percentage of patients that the eligible professional indicated a quality action was or was not performed divi ded by the total number of patients in the

denominator of the measure. (c) Incentive payments . For 2007 to 2014, with respect to covered profes sional services furnished during a reporting period by an eligible pr ofessional, an eligible professional (or in the case of a group practice under para graph (i) of this section, a group practice) may receive an

incentive if-- (1) There are any quality measures that have been established under the PQRS that are applicable to any such services furnished by such professional (or in th e case of a group practice under paragraph (i) of this section, such gr oup practice) for such reporting period; and (2) If the eligible professi onal (or in the case of a group practice under paragraph (j) of

### CMS-1600-FC 1330

this section, the group practice) sa tisfactorily submits (as determin ed under paragraph (g) of this section for the eligible professiona l and paragraph (i) of this section for the group practice) to the Secretary data on such quality measures in a ccordance with the PQRS for such reporting period,

in addition to the amount otherwis e paid under section 1848 of the Ac t, there also must be paid to the eligible professional (o r to an employer or facility in the cases described in section 1842(b)(6)(A) of the Act or, in the case of a gro up practice under paragraph (i ) of this section, to the group practice) from the Federal Supplementa ry Medical Insurance Trust Fund established

under section 1841 of the Act an am ount equal to the applicable qua lity percent (as specified in paragraph (c)(3) of this section) of the eligible profe ssional’s (or, in the ca se of a group practice under paragraph (i) of this section, the group prac tice’s) total estimated allowed charges for all covered professional services furnished by the e ligible professional (or, in the case of a group practice under paragraph (i) of this section, by the group prac tice) during the reporting period. (3) The applicable quality percent is as follows: (i) For 2007 and 2008, 1.5 percent. (ii) For 2009 and 2010, 2.0 percent. (iii) For 2011, 1.0 percent. (iv) For 2012, 2013, and 2014, 0.5 percent. (4) For purposes of this paragraph (c)-- (i) The eligible professional’ s (or, in the case of a group practice under paragraph (i) of this section, the group practice’ s) total estimated allowed charges for covered professional services furnished during a reporting period are determined based on claims processed in the National Claims History (NCH) no later than 2 m onths after the end of the applicable reporting period;

### CMS-1600-FC 1331

(ii) In the case of the eligible professional who furnishes covered professional services in more than one practice, incentive payments are separately determined for each practice based on claims submitted for the eligible professional for each practice; (iii) Incentive payments to a group practice unde r this paragraph must be in lieu of the payments that would otherwise be made under th e PQRS to eligible professionals in the group practice for meeting the criteria for satisfactory reporting for individual eligible professionals. For any program year in which the group practice (as identified by the TIN) is selected to participate in the PQRS group practice reporting op tion, the eligible professional cannot individually qualify for a PQRS incentive paymen t by meeting the requirements specified in paragraph (g) of this section. (iv) Incentive payments earne d by the eligible professiona l (or in the case of a group practice under paragraph (i) of th is section, by the group practice) for a particular program year will be paid as a single consolidated payment to the TIN holder of record. (5) The Secretary must treat an individual el igible professional, as identified by a unique TIN/NPI combination, as satisfactorily submitting data on quality measures (as determined under paragraph (g) of this section), if the eligible professional is satisfactorily participating (as determined under paragraph (h) of this sectio n), in a qualified clinical data registry. (d) Additional incentive payment . Through 2014, if an eligible professional meets the requirements described in paragraph (d)(2) of this section, the applicable percent for such year, as described in paragraphs (c)(3) (iii) and (iv) of this section, mu st be increased by 0.5 percentage points. (1) In order to qualify for the additional in centive payment described in paragraph (d) of this section, an eligible pr ofessional must meet all of the following requirements:

### CMS-1600-FC 1332

(i) Satisfactorily submits data on quality meas ures, or, for 2014, in lieu of satisfactory reporting, satisfactorily participates in a qualified clinical data registry for purposes of this section for the applicable incentive year. (ii) Have such data submitted on their beha lf through a Maintenan ce of Certification program that meets: (A) The criteria for a regist ry (as specified by CMS); or (B) An alternative form and manner determined appropriate by the Secretary. (iii) The eligible professional, more frequently than is required to qualify for or maintain

board certification status-- (A) Participates in a maintenance of certification program for a year; and (B) Successfully completes a qualified main tenance of certification program practice assessment for such year. (2) In order for an eligible professional to receive the additional incentive payment, a

Maintenance of Certification Pr ogram must submit to the Secret ary, on behalf of the eligible professional, information-- (i) In a form and manner specified by the S ecretary, that the eligible professional has successfully met the requirements of paragraph (d)(1)(iii) of this section, which may be in the

form of a structural measure. (ii) If requested by the Secretary, on the survey of patient experience with care. (iii) As the Secretary may require, on the methods, measures, and data used under the

Maintenance of Certification Pr ogram and the qualified Maintena nce of Certification Program practice assessment. (e) Payment adjustments . For 2015 and subsequent years, with respect to covered

### CMS-1600-FC 1333

professional services furnished by an eligible pr ofessional, if the eligib le professional does not satisfactorily submit data on quality measures fo r covered professional services for the quality reporting period for the year (as determined unde r section 1848(m)(3)(A) of the Act), the fee schedule amount for such services furnished by su ch professional during th e year (including the fee schedule amount for purposes for determinin g a payment based on such amount) must be equal to the applicable percent of the fee schedule amount that would otherwise apply to such services under this paragraph (e). (1) The applicable percent is as follows: (i) For 2015, 98.5 percent. (ii) For 2016 and each subsequent year, 98 percent. (2) The Secretary must treat an individual el igible professional, as identified by a unique TIN/NPI combination, as satisfactorily submitting data on quality measures (as determined under paragraph (h) of this section), if the eligible profe ssional is satisfactorily participating, in a qualified clinical data registry. (f) Use of appropriate and c onsensus-based quality measures . For measures selected for inclusion in the PQRS quality measure set, CM S will use group practice measures determined appropriate by CMS and consensu s-based quality measures that meet one of the following

criteria.: (1) Be such measures selected by the Secret ary from measures that have been endorsed by the entity with a contr act with the Secretary unde r section 1890(a) of the Act. In the case of a specified area or medical topic determined appr opriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under section 1890(a) of the Act, the Secretary may specify a measure that is not so endorsed as lo ng as due consideration

### CMS-1600-FC 1334

is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary. (2) For each quality measure adopted by the Secretary under this paragraph, the Secretary ensures that eligible professiona ls have the opportunity to provid e input during the development, endorsement, or selection of quality measures applicable to services they furnish. (g) Use of quality measures for satisfactory participation in a qualified clinical data registry . For measures selected for reporting to meet the criteria for satisfactory participation in a qualified clinical data registry, CMS will use measures selected by qualified clinical data registries based on parameters set by CMS. (h) Satisfactory reporting require ments for the incentive payments . In order to qualify to earn a PQRS incentive payment for a particular progr am year, an individual eligible professional, as identified by a unique TIN/NPI combination, must meet the criteria for satisfactory reporting specified by CMS under paragraph (h)(3) of (h)(5) of this section for such year by reporting on either individual PQRS quality measures or PQ RS measures groups identified by CMS during a reporting period specified in pa ragraph (h)(1) of this secti on, using one of the reporting mechanisms specified in paragraph (h)(2) or (4) of this section, and us ing one of the reporting criteria specified in paragraph (h)(3) or (5) of this section. (1) Reporting periods . For purposes of this paragr aph, the reporting period is-- (i) The 12–month period from January 1 through December 31 of such program year. (ii) A 6–month period from July 1 through December 31 of such program year. (A) For 2011, such 6–month repor ting period is not available for EHR–based reporting of individual PQRS quality measures. (B) For 2012 and subsequent program years, such 6–month reporting period from July 1

### CMS-1600-FC 1335

through December 31 of such program year is on ly available for regist ry-based reporting of PQRS measures groups by eligible professionals. (2) Reporting mechanisms for i ndividual eligible professionals . An individual eligible professional who wishes to participate in the PQRS must report information on PQRS quality measures identified by CMS in one of the following manners: (i) Claims . Reporting PQRS quality measures or PQRS measures groups to CMS, by no later than 2 months after the end of the appli cable reporting period, on the eligible professional’s Medicare Part B claims for covered professi onal services furnished during the applicable reporting period. (A) If an eligible professional re-submits a Medicare Part B claim for reprocessing, the eligible professional may not at tach a G–code at that time fo r reporting on individual PQRS

measures or measures groups. (B) [Reserved] (ii) Registry . Reporting PQRS quality measures or PQRS measures groups to a qualified registry in the form and manner and by the deadli ne specified by the qualified registry selected by the eligible professional. The selected regist ry must submit information, as required by CMS, for covered professional services furnished by th e eligible professional during the applicable reporting period to CMS on the eligible professional’s behalf. (iii) Direct EHR product . Reporting PQRS quality measures to CMS by extracting clinical data using a secure data submissi on method, as required by CMS, from a direct EHR product by the deadline specified by CMS for c overed professional serv ices furnished by the eligible professional during th e applicable reporting period. (iv) EHR data submission vendor . Reporting PQRS quality measures to CMS by

### CMS-1600-FC 1336

extracting clinical data using a secure data submission method, as required by CMS, from an EHR data submission vendor product by the deadlin e specified by CMS for covered professional services furnished by the eligible professi onal during the applicable reporting period. (v) Although an eligible pr ofessional may attempt to qua lify for the PQRS incentive payment by reporting on both individual PQRS qu ality measures and measures groups, using more than one reporting mechanis m (as specified in paragraph (g)(2) of this section), or reporting for more than one reporting period, he or she will receive only one PQRS incentive payment per TIN/NPI combination for a program year. (3) Satisfactory reporting criteria for individu al eligible professionals for the 2014 PQRS

incentive . An individual eligible professional who wishes to qualify for the 2014 PQRS incentive must report information on PQRS qua lity measures data in one of the following

manners: (i) Via Claims . For the 12-month 2014 PQRS incentive reporting period— (A) Report at least 9 measures covering at le ast 3 National Quality Strategy domains, and report each measure for at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to which the measure applies; or if less than 9 measur es covering at least 3 National Quality Strategy domains apply to the e ligible professional, re port 1 to 8 measures covering 1 to 3 National Quality Strategy domai ns and report each measure for at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to which the measure applies. For an eligib le professional who reports fewe r than 9 measures covering at least 3 NQS domains via the claims-based reporti ng mechanism, the eligib le professional would be subject to the Measures Applicability Validat ion process, which would allow us to determine whether an eligible professional should have reported quality da ta codes for additional measures

### CMS-1600-FC 1337

and/or covering additional National Quality Strategy domains. Measures with a 0 percent performance rate would not be counted. (B) [Reserved] 

### (ii) Via Qualified Registry . (A) For the 12-month 2014 PQRS incentive reporting period— (1) Report at least 9 measures covering at least 3 of the National Quality Strategy domains report each measure for at least 50 percent of the elig ible professional’s Medicare Part B FFS patients seen during the reporting period to which the measure appli es; or, if less than 9 measures covering at least 3 NQS domains apply to the eligible professional, report 1 to 8 measur es covering 1 to 3 National Quality Strategy domains for which there is Medicare patient data and report each measure for at least 50 percent of the eligible professional’s Medicare Part B FFS patients seen during the reporting period to which the measure applies. For an eligible professional who re ports fewer than 9 measures covering at least 3 NQS domains via the qualified registry-based reporting mechan ism, the eligible professional will be subject to the Measures Applicability Validation process, which w ould allow us to determine whether an eligible professional should have reported on additional measu res and/or measures covering additional National Quality Strategy domains. Measures with a 0 pe rcent performance rate would not be counted. 

### (2 ) Report at least 1 measures group and re port each measures group for at least 20 patients, a majority of which much be Medicare Part B FFS patients. Measures with a 0 percent performance rate or measures groups containing a measure with a 0 percent performance rate

will not be counted. (B) For the 6-month 2014 PQRS incentive repo rting period, report at least 1 measures group and report each measures group for at leas t 20 patients, a majority of which much be Medicare Part B FFS patients. Measures gr oups containing a measur e with a 0 percent performance rate will not be counted.

### CMS-1600-FC 1338

(iii) Via EHR Direct Product . For the 12-month 2014 PQRS incentive reporting period, report 9 measures covering at leas t 3 of the National Quality Strate gy domains. If an eligible professional's CEHRT does not contain patient data for at least 9 measures covering at least 3 domains, then the eligible professional must report the measures for which there is Medicare patient data. An eligible professional must report on at least 1 measure for which there is Medicare patient data. (iv) Via EHR Data Submission Vendor . For the 12-month 2014 PQRS incentive reporting period, report 9 measures covering at least 3 of the Nationa l Quality Strategy domains. If an eligible professional's CE HRT does not contain patient data for at least 9 measures covering at least 3 domains, then the eligible professi onal must report the measures for which there is Medicare patient data. An elig ible professional must report on at least 1 measure for which there is Medicare patient data. (4) Reporting mechanisms for group practices . With the exception of a group practice who wishes to participate in the PQRS using th e certified survey vendor mechanism (as specified in paragraph (h)(4)(v) of this section), a group practice must report information on PQRS quality measures identified by CMS in one of the following reporting mechanisms: (i) Web interface . For 2013 and subsequent years, reporting PQRS quality measures to CMS using a CMS web interface in the form and manner and by the deadline specified by CMS. (ii) Registry . For 2013 and subsequent years, reporting on PQRS quality measures to a qualified registry in the form and manner and by the deadline specified by the qualified registry selected by the eligible professional. The select ed registry must submit information, as required by CMS, for covered professional services furn ished by the eligible professional during the applicable reporting period to CMS on th e eligible professional’s behalf.

### CMS-1600-FC 1339

(iii) Direct EHR product . For 2014 and subsequent years, reporting PQRS quality measures to CMS by extracting clinical data us ing a secure data submission method, as required by CMS, from a direct EHR product by the deadli ne specified by CMS for covered professional services furnished by the eligible professi onal during the applicable reporting period. (iv) EHR data submission vendor . For 2014 and subsequent years, reporting PQRS quality measures to CMS by extracting clinical data using a secure da ta submission method, as required by CMS, from an EHR data submissi on vendor product by the deadline specified by CMS for covered professional services furnis hed by the eligible pr ofessional during the applicable reporting period. (v) Certified survey vendors . For 2014 and subsequent years, reporting CAHPS survey measures to CMS using a vendor that is certif ied by CMS for a particular program year to transmit survey measures data to CMS. Group practices that elect this reporting mechanism must select an additional group practice reporting mechanism in order to meet the criteria for satisfactory reporting for the incentive payments. (vi) Although a group practice may attempt to qualify for the PQRS incentive payment by using more than one reporting mechanism (as specifi ed in paragraph (g)(3) of this section), or reporting for more than one reporting period, the group practice will r eceive only one PQRS incentive payment for a program year. (5) Satisfactory reporting criteria for gr oup practices for the 2014 PQRS incentive . A group practice who wishes to qualify for the 2014 PQRS incentive must report information on PQRS quality measures identified by CMS in one of the following manners: (i) Via the GPRO web interface . (A) For the 12-month 2014 PQRS incentive reporting period, for a group practice of 25 to 99 eligible pr ofessionals, report on all measures included in

### CMS-1600-FC 1340

the web interface and populate data fields for the first 218 consecutively ranked and assigned beneficiaries in the order in which they a ppear in the group’s sample for each module or preventive care measure. If the pool of eligib le assigned beneficiaries is less than 218, then report on 100 percent of a ssigned beneficiaries. (B) For the 12-month 2014 PQRS incentive repo rting period, for a group practice of 100 or more eligible professionals, report on all measures included in the web interface and populate data fields for the first 411 consecutively ranked and assigned beneficiaries in the order in which they appear in the group’s sample for each module or preventive care measure. If the pool of eligible assigned beneficiarie s is less than 411, then report on 100 percent of assigned beneficiaries. In addition, for the 12-m onth 2014 PQRS incentive re porting period, the group practice must report all CG CAHPS survey meas ures via a CMS-certified survey vendor, and report at least 6 measures covering at least 2 of the National Quality Strategy domains using a qualified registry, direct EHR product, or EHR da ta submission vendor. (ii) Via Qualified Registry . For the 12-month 2014 PQRS incentive reporting period, for a group practice of 2 or more eligib le professionals, repo rt at least 9 measures , covering at least 3 of the National Quality Strategy domains and repor t each measure for at least 50 percent of the group practice’s Medicare Part B FFS patients seen during the reporti ng period to which the measure applies; or, if less than 9 measures covering at least 3 NQS domains 

### apply to the group practice, then the group practice must report 1-8 measures for which there is Medicare patient data and report each measure for at least 50 perc ent of the group practice’ s Medicare Part B FFS patients seen during the reporting period to which the measure applies. For a group practice who reports fewer than 9 measures covering at least 3 NQS domains 

### via the qualified registry-based reporting mechanism, the group practice would be subject to the Measures Applicability

### CMS-1600-FC 1341

Validation process, which would allow us to determine whether a group practice should have reported on additional measures and/or measures covering additional National Quality Strategy domains. Measures with a 0 percent perf ormance rate would not be counted. (iii) Via EHR Direct Product . For the 12-month 2014 PQRS incentive reporting period, for a group practice of 2 or more eligible professi onals, report 9 measures covering at least 3 of the National Quality Strategy domains. If a group practice's CEHRT does not contain patient data for at least 9 measures covering at least 3 domains, then the group practice must report the measures for which there is Medicare patient data. A group practice must report on at least 1 measure for which there is Medicare patient data. (iv) Via EHR Data Submission Vendor . For the 12-month 2014 PQRS incentive reporting period, for a group practice of 2 or more eligible professionals, report 9 measures covering at least 3 of the Nati onal Quality Strategy domains. If a group practice's CEHRT does not contain patient data for at least 9 measures covering at least 3 domains, then the group practice must report the measures for which ther e is Medicare patient data. A group practice must report on at least 1 measure for which there is Medicare patient data. (v) Via a Certified survey vendor, in addi tion to the GPRO web interface, qualified registry, direct EHR product, or EHR da ta submission vendor reporting mechanisms . For the 12- month 2014 PQRS incentive reporting period, for a group practice of 25 or more eligible professionals, report all CG CAHPS survey meas ures via a CMS-certified survey vendor, and report at least 6 measures covering at least 2 of the National Quality Strategy domains using a qualified registry, direct EHR product, EHR data submission vendor, or GPRO web interface. (i) Satisfactory participati on requirements for the incentiv e payments for individual eligible professionals . To qualify for the 2014 PQRS incentive using a qualified clinical data

### CMS-1600-FC 1342

registry, an individual eligible professional, as identified by a unique TIN/NPI combination, must meet the criteria for satisfactory participat ion as specified under paragraph (i)(3) of this section by reporting on quality measures identified by a qualified clinical data registry during a reporting period specified in paragraph (i)(1) of this section, and usi ng the reporting mechanism specified in paragraph (i )(2) of this section. (1) Reporting period . For purposes of this paragraph, the reporting period is the 12– month period from January 1 through December 31. (2) Reporting Mechanism . An individual eligible profe ssional who wishes to meet the criteria for satisfactory participation in a qualifie d clinical data registry must use a qualified clinical data registry to report information on quality measures iden tified by the qualified clinical data registry. (3) Satisfactory participation criteria for individual elig ible professionals for the 2014 PQRS incentive . An individual eligible professional who wishes to qualify for the 2014 PQRS incentive through satisfactory part icipation in a qualified clini cal data registry must report information on quality measures id entified by the qualified clinical data registry in the following

manner: (i) For the 12-month 2014 PQRS incentive repo rting period, report at least 9 measures designated for reporting under a qualifi ed clinical data registry cove ring at least 3 of the National Quality Strategy domains and report each measur e for at least 50 percent of the eligible professional’s patients. Of the measures reported via a qualified clinical data registry, the eligible professional must report on at least 1 outcome measure. (ii) [Reserved].

### CMS-1600-FC 1343

(j) Satisfactory reporting requirements for the payment adjustments . In order to satisfy the requirements for the PQRS payment adjustment for a particular program year, an individual eligible professional, as iden tified by a unique TIN/NPI combin ation, or a group practice must meet the criteria for satisfactory reporting speci fied by CMS for such year by reporting on either individual PQRS measures or PQRS measures groups identified by CMS during a reporting period specified in paragraph (j)(1) of this se ction, using one of th e reporting mechanisms specified in paragraph (j)(2) or (4) of this se ction, and using one of the reporting criteria specified in section (j)(3) or (5) of this section. (1) For purposes of this paragraph (j), th e reporting period for the payment adjustment, with respect to a payment adjustment year, is the 12–month period from January 1 through December 31 that falls 2 years prior to the year in which the payment adjustment is applied. (i) For the 2015 and 2016 PQRS payment ad justments only, an alternative 6–month reporting period, from July 1–December 31 that fa ll 2 years prior to th e year in which the payment adjustment is applied, is also available. (ii) [Reserved] (2) Reporting mechanisms for i ndividual eligible professionals . An individual eligible professional participating in the PQRS must report information on PQRS quality measures identified by CMS in one of the following manners: (i) Claims . Reporting PQRS quality measures or PQRS measures groups to CMS, by no later than 2 months after the end of the appli cable reporting period, on the eligible professional’s Medicare Part B claims for covered professi onal services furnished during the applicable reporting period.

### CMS-1600-FC 1344

(A) If an eligible professional re-submits a Medicare Part B claim for reprocessing, the eligible professional may not at tach a G–code at that time fo r reporting on individual PQRS

measures or measures groups. (B) [Reserved] (ii) Registry . Reporting PQRS quality measures or PQ RS measures groups to a qualified registry in the form and manner and by the deadli ne specified by the qualified registry selected by the eligible professional. Th e selected registry must submit information, as required by CMS, for covered professional services furnished by th e eligible professional during the applicable reporting period to CMS on the eligible professional’s behalf. (iii) Direct EHR product . Reporting PQRS quality measures to CMS by extracting clinical data using a secure data submissi on method, as required by CMS, from a direct EHR product by the deadline specified by CMS for c overed professional serv ices furnished by the eligible professional during th e applicable reporting period. (iv) EHR data submission vendor . Reporting PQRS quality measures to CMS by extracting clinical data using a secure data submission method, as required by CMS, from an EHR data submission vendor product by the deadlin e specified by CMS for covered professional services furnished by the eligible professi onal during the applicable reporting period. (v) Administrative claims . For 2015, reporting data on PQRS quality measures via administrative claims during the applicable repo rting period. Eligible pr ofessionals that are administrative claims reporters must meet the fo llowing requirement for the payment adjustment: (A) Elect to participate in the PQRS using the administ rative claims reporting option. (B) Reporting Medicare Part B claims data for CMS to determine whether the eligible professional has performed services applicable to certain individual PQRS quality measures.

### CMS-1600-FC 1345

(3) Satisfactory reporting criteria for individu al eligible professionals for the 2016 PQRS payment adjustment . An individual eligible professiona l who wishes to meet the criteria for satisfactory reporting for the 2016 PQRS payment adjustment must report information on PQRS quality measures identified by CMS in one of the following manners: (i) Via Claims . (A) For the 12-month 2016 PQRS payment adjustment reporting period— (1 )(i ) Report at least 9 measures covering at least 3 National Quality Strategy domains and report each measure for at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to wh ich the measure applies; or if less th an 9 measures covering at least 3 NQS domains apply to the eligible professi onal, report 1—8 measures covering 1—3 National Quality Strategy domains, and report each measure fo r at least 50 percent of the Medicare Part B FFS patients seen during the report ing period to which the measure applies. For an eligible professional who reports fewer than 9 measures covering at least 3 NQS domains via the claimsbased reporting mechanism, the eligible prof essional would be subj ect to the Measures Applicability Validation process, which would allow us to determine whether an eligible professional should have reported quality data codes for additi onal measures and/or covering additional National Quality Strategy domains; or (ii ) Report at least 3 measures covering at leas t 1 NQS domain, or, if less than 3 measures covering at least 1 NQS domain apply to the eligible professional, report 1—2 measures covering at least 1 NQS domain; and report each m easure for at least 50 percent of the eligible professional’s Medicare Part B FFS patients s een during the reporting period to which the measure applies. (2 ) Measures with a 0 percent performance rate would not be counted.

### CMS-1600-FC 1346

(ii) Via Qualified Registry . (A) For the 12-month 2016 PQRS payment adjustment reporting period— (1 )(i ) Report at least 9 measures covering at least 3 of the National Quality Strategy domains; or if less than 9 m easures covering at least 3 NQS domains apply to the eligible professional, report 1 to 8 measures covering 1 to 3 National Quality Strategy domains for which there is Medicare patient data, a nd report each measure for at le ast 50 percent of the eligible professional’s Medicare Part B FFS patients s een during the reporting period to which the measure applies. For an eligib le professional who reports fewe r than 9 measures covering at least 3 NQS domains via the qua lified registry-based reporting mechanism, the eligible professional would be subject to the Measures Applicability Va lidation process, which would allow us to determine whether an eligible pr ofessional should have reported on additional measures and/or measures covering additi onal National Quality Strategy domains; or (ii ) Report at least 3 measures covering at leas t 1 of the NQS domains; or if less than 3 measures covering at least 1 NQS domain apply to the eligible professi onal, report 1 to 2 measures covering 1 National Quality Strategy doma in for which there is Medicare patient data, and report each measure for at least 50 percent of the eligible professional’s Medicare Part B FFS patients seen during the report ing period to which the measure applies. For an eligible professional who reports fewer than 3 measures covering 1 NQS domain vi a the registry-based reporting mechanism, the eligible professional w ould be subject to the Measures Applicability Validation process, which would allow us to dete rmine whether an eligible professional should have reported on additional measures; or (iii ) Report at least 1 measures group and re port each measures group for at least 20 patients, a majority of which much be Medicare Part B FFS patients.

### CMS-1600-FC 1347

(2) Measures with a 0 percent performance rate or measures groups containing a measure with a 0 percent performance rate will not be counted. (B) For the 6-month 2016 PQRS pa yment adjustment reporting period— (1 ) Report at least 1 measures group and re port each measures group for at least 20 patients, a majority of which much be Medi care Part B FFS patients. Measures groups containing a measure with a 0 percent pe rformance rate will not be counted. (iii) Via EHR Direct Product . For the 12-month 2016 PQRS payment adjustment reporting period, report 9 measures covering at least 3 of the Nationa l Quality Strategy domains. If an eligible professional's CE HRT does not contain patient data for at least 9 measures covering at least 3 domains, then the eligible professi onal must report the measures for which there is Medicare patient data. An elig ible professional must report on at least 1 measure for which there is Medicare patient data. (iv) Via EHR Data Submission Vendor . For the 12-month 2016 PQRS payment adjustment reporting period, report 9 measures covering at least 3 of the National Quality Strategy domains. If an eligible professional's CEHRT does not contain patie nt data for at least 9 measures covering at least 3 domains, then the el igible professional must report the measures for which there is Medicare patient data. An eligib le professional must report on at least 1 measure for which there is Medicare patient data. (4) Reporting mechanisms for group practices . With the exception of a group practice who wishes to participate in the PQRS using the certified survey vendor mechanism, a group practice participating in the PQRS must report information on PQRS quality measures identified by CMS in one of the following reporting mechanisms:

### CMS-1600-FC 1348

(i) Web interface . For the 2015 payment adjustment and subsequent payment adjustments, reporting PQRS quality measures to CMS using a CMS web interface in the form and manner and by the deadline specified by CMS. (ii) Registry . For the 2015 subsequent adjustment and subsequent payment adjustments, reporting on PQRS quality measures to a qualified registry in the form and manner and by the deadline specified by the qualified registry select ed by the eligible professional. The selected registry will submit information, as required by CMS, for covered pr ofessional services furnished by the eligible pr ofessional during the applicable reporting period to CMS on the eligible professional’s behalf. (iii) Direct EHR product . For the 2016 subsequent adjustment and subsequent payment adjustments, reporting PQRS quality measures to CMS by extracting clinical data using a secure data submission method, as required by CMS, from a direct EHR product by the deadline specified by CMS for covered prof essional services furnished by th e eligible professional during the applicable reporting period. (iv) EHR data submission vendor . For the 2016 subsequent adjustment and subsequent payment adjustments, reporting PQRS quality measures to CMS by extracting clinical data using a secure data submission method, as required by CMS, from an EHR data submission vendor product by the deadline specified by CMS for c overed professional serv ices furnished by the group practice during the a pplicable reporting period. (v) Administrative claims . For 2015, reporting data on PQRS quality measures via administrative claims during the applicable reporting period. Group practices that are administrative claims reporters must meet the fo llowing requirement for the payment adjustment: (A) Elect to participate in the PQRS using the administ rative claims reporting option.

### CMS-1600-FC 1349

(B) Reporting Medicare Part B claims data for CMS to determine whether the group practice has performed services applicable to certain indivi dual PQRS quality measures. (vi) Certified Survey Vendors . For 2016 and subsequent ye ars, reporting CAHPS survey measures to CMS using a vendor that is certif ied by CMS for a particular program year to transmit survey measures data to CMS. Group practices that elect this reporting mechanism must select an additional group practice reporting mechanism in order to meet the criteria for satisfactory reporting for the payment adjustment. (5) Satisfactory reporting criteria for gr oup practices for the 2016 PQRS payment adjustment . A group practice who wishes to meet th e criteria for satisfact ory reporting for the 2016 PQRS payment adjustment must report info rmation on PQRS quality measures identified by CMS in one of the following manners: (i) Via the GPRO web interface . (A) For the 12-month 2016 PQRS payment adjustment reporting period, for a group practice of 25 to 99 e ligible professionals, report on all measures included in the web interface and populate data fi elds for the first 218 consecutively ranked and assigned beneficiaries in the order in which they appear in the group’s sample for each module or preventive care measure. If the pool of eligib le assigned beneficiaries is less than 218, then report on 100 percent of a ssigned beneficiaries. (B) For the 12-month 2016 PQRS payment adjustment reporting period, for a group practice of 100 or more eligib le professionals, report on all measures included in the web interface and populate data fields for the fi rst 411 consecutively ranked and assigned beneficiaries in the order in which they a ppear in the group’s sample for each module or preventive care measure. If the pool of eligib le assigned beneficiaries is less than 411, then

### CMS-1600-FC 1350

report on 100 percent of assigned be neficiaries. In addition, the group practice must also report all CG CAHPS survey measures via certified survey vendor. (ii) Via Qualified Registry . (A) For the 12-month 2016 PQRS payment adjustment reporting period , for a group practice of 2 or more eligible professionals-- (1 ) Report at least 9 measures, covering at least 3 of the Natio nal Quality Strategy domains and report each measure for at least 50 pe rcent of the group practices’s Medicare Part B FFS patients seen during the reportin g period to which the measure a pplies; or If less than 9 measures covering at least 3 NQS domains apply to the eligible profe ssional, then the group practices must report 1-8 measures for which th ere is Medicare patient data and report each measure for at least 50 percent of the group prac tices’s Medicare Part B FFS patients seen during the reporting period to wh ich the measure applies. For a gr oup practice who reports fewer than 9 measures covering at least 3 NQS domains via the registry-based reporting mechanism, the group practice would be subject to the Measures Applicability Va lidation process, which would allow us to determine whether an group practic e should have reported on additional measures. Measures with a 0 percent performance rate would not be counted; or (2 ) Report at least 3 measures, covering at least 1 of the Natio nal Quality Strategy domains and report each measure for at least 50 pe rcent of the group practice’s Medicare Part B FFS patients seen during the reportin g period to which the measure a pplies; or if less than 3 measures covering at least 1 NQS domain apply to the group practice, then the group practice must report 1-2 measures for which there is Medicar e patient data and report each measure for at least 50 percent of the group pr actice’s Medicare Part B FFS patie nts seen during the reporting period to which the measure applies. For a gr oup practice who reports fewer than 3 measures covering at least 1 NQS domain via the registry -based reporting mechanism, the group practice

### CMS-1600-FC 1351

would be subject to the Measur es Applicability Validation pro cess, which would allow us to determine whether an group practice should have reported on additional measures. Measures with a 0 percent performance rate would not be counted. (iii) Via EHR Direct Product . For a group practice of 2 or more eligible professionals, for the 12-month 2016 PQRS payment adjustment reporting period, report 9 measures covering at least 3 of the National Quality Strategy domains. If a group practice's CEHRT does not contain patient data for at least 9 measures cove ring at least 3 domains, then the group practice must report the measures for which there is Medi care patient data. A gr oup practice must report

on at least 1 measure for which there is Medicare patient data. (iv) Via EHR Data Submission Vendor . For a group practice of 2 or more eligible professionals, for the 12-month 2016 PQRS paym ent adjustment reporting period, report 9 measures covering at least 3 of the National Qu ality Strategy domains. If a group practice's CEHRT does not contain patient da ta for at least 9 measures c overing at least 3 domains, then the group practice must report the measures for wh ich there is Medicare patient data. A group practice must report on at least 1 measure fo r which there is Medicare patient data. (v) Via a Certified survey vendor, in addi tion to the GPRO web interface, qualified registry, direct EHR product, or EHR da ta submission vendor reporting mechanisms . For a group practice of 25 or more eligible profe ssionals, for the 12-month 2016 PQRS payment adjustment reporting period, report all CG CAHPS survey measures via a CMS-certified survey vendor and report at least 6 meas ures covering at least 2 of the National Quality Strategy domains using a qualified registry, direct EHR product, EHR data submission vendor, or GPRO

web interface.

### CMS-1600-FC 1352

(k) Satisfactory participati on requirements for the payment adjustments for individual eligible professionals . In order to satisfy the requirements for the PQRS payment adjustment for a particular program year through participation in a qualified clinical data registry, an individual eligible professional, as iden tified by a unique TIN/NPI combinat ion, must meet the criteria for satisfactory participation as specified in paragr aph (k)(3) for such year, by reporting on quality measures identified by a qualified clinical data registry during a reporting period specified in paragraph (k)(1) of this section, using the reporting mechanism sp ecified in paragraph (k)(2) of

this section. (1) Reporting period. For purposes of th is paragraph, the reporting period is— (i) The 12–month period from January 1 thr ough December 31 that falls 2 years prior to the year in which the payment adjustment is applied. (ii) [Reserved.] (2) Reporting Mechanism . An individual eligible profe ssional who wishes to meet the criteria for satisfactory participation in a qualified clinical data registry must use the qualified clinical data registry to report information on quality measures iden tified by the qualified clinical data registry. (3) Satisfactory participation criteria for individual elig ible professionals for the 2016 PQRS payment adjustment. An individual eligible professional who wishes to meet the criteria for satisfactory participation in a qualified clinical data regi stry for the 2016 PQRS payment adjustment must report information on quality m easures identified by the qualified clinical data registry in one of the following manners: (i) For the 12-month 2016 PQRS paym ent adjustment reporting period—

### CMS-1600-FC 1353

(A) Report at least 9 measures available fo r reporting under a qualif ied clinical data registry covering at least 3 of the National Qual ity Strategy domains and report each measure for at least 50 percent of the eligible professional’s patients; or (B) Report at least 3 measures available fo r reporting under a qualif ied clinical data registry covering at least 1 of the National Qu ality Strategy domains and report each measure for at least 50 percent of the eligible professional’s patients (l) Requirements for group practices . Under the PQRS, a group pr actice must meet all of the following requirements: (1) Meet the participation requirements sp ecified by CMS for the PQRS group practice reporting option. (2) Report measures in the form and manner specified by CMS. (3) Meet other requirements for sa tisfactory reporting specified by CMS. (4) Meet other requirements for sa tisfactory reporting specified by CMS. (5) Meet participation requirements. (i) If an eligible professional, as identified by an individual NPI, ha s reassigned his or her Medicare billing rights to a group practice (as identified by the TIN) selected to participate in the PQRS group practice reporting optio n for a program year, then for that program year the eligible professional must participate in the PQ RS via the group practice reporting option. (ii) If, for the program year, th e eligible professional participat es in the PQRS as part of a group practice (as identified by the TIN) that is not selected to participate in the PQRS group practice reporting option for that program year, then the eligib le professional may individually participate and qualify for a PQRS incentive by meeting the require ments specified in paragraph (g) of this section under that TIN.

### CMS-1600-FC 1354

(m) Informal review . Eligible professionals or group practices may seek an informal

review of the determination that an eligible professional or gr oup practices did not satisfactorily submit data on quality measures und er the PQRS, or, for individual el igible professionals, in lieu of satisfactory reporting, did not satisfactorily participate in a qualified clinical data registry. (1) To request an informal review, an eligib le professional or group practices must submit a request to CMS within 90 days of the release of the feedback reports. The request must be submitted in writing and summarize the concern(s) and reasons for requesting an informal review and may also include inform ation to assist in the review. (2) CMS will provide a written response within 90 days of the receipt of the original request. (i) All decisions based on the informal review will be final. (ii) There will be no further review or appeal. (n) Limitations on review

. Except as specified in paragraph (i) of this section, there is no administrative or judicial review under secti on 1869 or 1879 of the Act, or otherwise of— (1) The determination of m easures applicable to services furnished by eligible professionals under the PQRS; (2) The determination of satisfactory reporting; and (3) The determination of any Physician Quality Reporting System incentive payment and the PQRS payment adjustment. (o) Public reporting of an eligible professional’s or group practice’s PQRS data . For each program year, CMS will post on a public Web site , in an easily understandable format, a list of the names of eligible professionals (or in th e case of reporting under paragraph (g) of this section, group practices) w ho satisfactorily submitted PQRS quality measures.

### CMS-1600-FC 1355

32. Section 414.511 is added to s ubpart G to read as follows: §414.511 Adjustments to the Clinical Laborato ry Fee Schedule based on Technological Changes. (a) CMS may make adjustments to the fee schedules as CMS determines are justified by technological changes. (b) Technological changes are changes to the tools, machines, supplies, labor, instruments, skills, techniques, and devices by wh ich laboratory tests are produced and used. (c) CMS will propose and finalize any ad justments to the fee schedules as CMS determines are justified by technological changes in the Federal Register

. 33. Section 414.610 is amended by— A. Revising paragraphs (c)(1)(ii) and (c)(5)(ii). B. Adding paragraph (c)(8). C. Revising paragraph (h).

The revisions and addition read as follows: §414.610 Basis of payment.

* * * * * (c)* * * (1)* * * (ii) For services furnished during the period July 1, 2008 through December 31, 2013, ambulance services originating in: (A) Urban areas (both base rate and mileage) are paid based on a rate that is 2 percent higher than otherwise is applicable under this section. (B) Rural areas (both base rate and mileage) are pa id based on a rate that is 3 percent higher than otherwise is applicable under this section.

* * * * *

### CMS-1600-FC 1356

(5) * * * (ii) For services furnished during the period Ju ly 1, 2004 through December 31, 2013, the payment amount for the ground ambulance base rate is increased by 22.6 percent where the point of pickup is in a rural area determined to be in th e lowest 25 percent of rural population arrayed by population density. The amount of this increase is based on CMS’s estimate of the ratio of the average cost per trip for the rural areas in the lowest quartile of population compared to the average cost per trip for the rural areas in the highest quartile of popula tion. In making this estimate, CMS may use data provided by the GAO.

* * * * * (8) For ambulance services furnished on or afte r October 1, 2013 consisting of non-emergency basic life support (BLS) services involving transport of an individual with end-stage renal disease for renal dialysis services (as described in section 18 81(b)(14)(B)) furnished othe r than on an emergency basis by a provider of services or a renal dialysis facility, the fee schedule amount otherwise applicable (both base rate and mileage) is reduced by 10 percent.

* * * * * (h) Treatment of certain areas for payment for air ambulance services . Any area that was designated as a rural area for purposes of making pa yments under the ambulance fee schedule for air ambulance services furnished on December 31, 2006, must be treated as a rural area for purposes of making payments under the ambulance fee schedule for air ambulance services furnished during the period July 1, 2008 through June 30, 2013. 

### 34. Section 414.1210 is amended by revising paragraphs (a) and (c) to read as follows: §414.1210 Application of the value-based payment modifier. (a) The value-based payment modifier is applicable: (1) For the CY 2015 payment adjustment peri od, to physicians in groups with 100 or more eligible professionals based on th e performance period de scribed at § 414.1215(a).

### CMS-1600-FC 1357

(2) For the CY 2016 payment adjustment peri od, to physicians in groups with 10 or more eligible professionals based on th e performance period de scribed at § 414.1215(b).

* * * * * (c) Group size determination. The list of groups of phys icians subject to the valuebased payment modifier for the CY 2015 paymen t adjustment period is based on a query of PECOS on October 15, 2013. For each subsequent calendar year payment adjustment period, the list of groups of physicians subject to the value-based payment modifier is based on a query of PECOS that occurs within 10 days of the close of the Physician Quality Reporting System group registration process during the applicable performance period described at § 414.1215. Groups of physicians are removed from the PECOS- generated list if, based on a claims analysis, the group of physicians did not have the required number of eligib le professionals, as defined in §414.1210(a), that submitted claims during the perfo rmance period for the applicable calendar year payment adjustment period. 35. Section 414.1215 is amended by adding pa ragraph (c) to read as follows: § 414.1215 Performance and payment adjustment periods for the value-based payment

modifier.

* * * * * (c) The performance period is calendar ye ar 2015 for value-based payment modifier adjustments made in the calendar ye ar 2017 payment adjustment period.

36. Section 414.1220 is revised to read as follows: § 414.1220 Reporting mechanisms for the value-based payment modifier. Groups of physicians subject to the value-base d payment modifier (or individual eligible professionals within such groups) may submit data on quality measures as specified under the

### CMS-1600-FC 1358

Physician Quality Reporting System using the repor ting mechanisms for which they are eligible.

37. Section 414.1225 is revised to read as follows: § 414.1225 Alignment of Physician Quality Re porting System quality measures and quality measures for the value-based payment modifier. All of the quality measures for which groups of physicians or individual eligible professionals are eligible to report under the Physician Qualit y Reporting System in a given calendar year are used to calculate the value-ba sed payment modifier for the applicable payment adjustment period, as defined in §414.1215, to th e extent a group of physicians or individual eligible professionals within such group submits data on such measures.

38. Section 414.1235 is revised to read as follows: § 414.1235 Cost measures. (a) Included measures . Beginning with the CY 2016 pa yment adjustment period, costs for groups of physicians subject to the value- based payment modifier are assessed based on a cost composite comprised of the following 6 cost measures (only the measures identified in paragraphs (a)(1) through (5) of this section are included for th e value-based payment modifier for the CY 2015 payment adjustment period): (1) Total per capita costs for all attributed beneficiaries. (2) Total per capita costs for all attrib uted beneficiaries with diabetes. (3) Total per capita costs for all attributed be neficiaries with coronary artery disease. (4) Total per capita costs for all attribut ed beneficiaries with chronic obstructive pulmonary disease. (5) Total per capita costs for all attributed beneficiaries with heart failure. (6) Medicare Spending per Beneficiary associated with an acute inpatient

### CMS-1600-FC 1359

hospitalization. (b) Included payments . Cost measures enumerated in paragraph (a) of this section include all fee-for-service payments ma de under Medicare Part A and Part B. (c) Cost measure adjustments . (1) Payments under Medicare Part A and Part B will be adjusted using CMS’ payment standardization methodology to ensure fair comparisons across geographic areas. (2) The CMS-HCC model (and adjustments fo r ESRD status) is used to adjust standardized payments for the measures listed at paragraphs (a)(1) throug h (5) of this section. (3) The beneficiary’s age and severity of illness are used to adjust the Medicare Spending per Beneficiary measure as specified in paragraph (a)(6) of this section.

39. Section 414.1240 is revised to read as follows: § 414.1240 Attribution for quality of care and cost measures. (a) Beneficiaries are attribut ed to groups of physicians subject to the value-based payment modifier using a method generally c onsistent with the method of assignment of

beneficiaries under § 425.402 of this chapter, for measures other than the Medicare Spending per Beneficiary measure. (b) For the Medicare Spendi ng per Beneficiary (MSPB) measure, an MSPB episode is attributed to the group of physicia ns subject to the value-based pa yment modifier whose eligible professionals submitted the plurality of claims (as measured by allowable charges) under the group’s TIN for Medicare Part B services, rendered during an inpatient hosp italization that is an index admission for the MSPB measure during the applicable performance period described at §

414.1215.

40. Section 414.1255 is revised to read as follows:

### CMS-1600-FC 1360

§ 414.1255 Benchmarks for cost measures. (a) For the CY 2015 payment adjustment peri od, the benchmark for each cost measure is the national mean of the performance rates calculated among all groups of physicians for

which beneficiaries are attributed to the group of physicians that are subject to the value-based payment modifier. In calcul ating the national benchmark, gr oups of physicians’ performance rates are weighted by the number of beneficiaries used to ca lculate the group of physician’s performance rate. (b) Beginning with the CY 2016 payment adjustment period, the cost measures of a group of physicians subject to the value-based pa yment modifier are adjusted to account for the group’s specialty mix, by computing the weighted average of the national specialty-specific expected costs. Each national specialty-specific expected cost is weighted by the proportion of each specialty in the group, the number of eligible professionals of each specialty in the group,

and the number of beneficiarie s attributed to the group. (c) The national specialty-speci fic expected costs referenced in paragraph (b) of this section are derived by calculating, for each specialt y, the average cost of be neficiaries attributed to groups of physicians that include that specialty. 41. Section 414.1260 is amended by revising pa ragraph (b)(1)(i) to read as follows: § 414.1260 Composite scores.

* * * * * (b) * * * (1) * * * (i) Total per capita costs for all attributed beneficiaries: Total pe r capita costs measure and Medicare Spending per Be neficiary measure; and

### CMS-1600-FC 1361

* * * * *

42. Section 414.1270 is revised to read as follows: § 414.1270 Determination and calculation of Va lue-Based Payment Modifier adjustments. (a) For the CY 2015 payment adjustment period: (1) Downward payment adjustments . A downward payment adjustment will be applied to a group of physicians subject to th e value-based payment modifier if-- (i) Such group neither self-nominates for the PQRS GPRO and reports at least one measure, nor elects the PQRS administrative claims opti on for CY 2013 as defined in §414.90(h). (A) Such adjustment will be -1.0 percent. (B) [Reserved]. (ii) Such group elects that its value-ba sed payment modifier be calculated using a quality-tiering approach, and is determined to have poor performance (low quality and high costs; low quality and average costs; or average quality and high costs). (A) Such adjustment will not exceed - 1.0 percent as specified in §414.1275(c)(1). (B) [Reserved]. (2) No payment adjustments . There will be no value-based payment modifier adjustment applied to a group of physicians subjec t to the value-based payment modifier if such group either: (i) Self-nominates for the PQRS GPRO a nd reports at least one measure; or (ii) Elects the PQRS admini strative claims option for CY 2013 as defined in §414.90(h). (3) Upward payment adjustments . If a group of physicians subject to the value-based payment modifier elects that the value-based pa yment modifier be calc ulated using a quality-

### CMS-1600-FC 1362

tiering approach, upward payment adjustments are determined based on the projected aggregate amount of downward payment adjustments determ ined under paragraph (a )(1) of this section and applied as specified in §414.1275(c)(1). (b) For the CY 2016 paymen t adjustment period: (1) A downward payment adjustment of - 2.0 percent will be applied to a group of physicians subject to the value- based payment modifier if, duri ng the applicable performance period as defined in §414.1215, the following apply: (i) Such group does not self-nominate for th e PQRS GPRO and meet the criteria as a group to avoid the PQRS payment adjustment for CY 2016 as specified by CMS; and (ii) Fifty percent of the eligib le professionals in such group do not meet the criteria as individuals to avoid the PQRS payment adju stment for CY 2016 as specified by CMS. (2) For a group of physicians comprised of 100 or more eligible profe ssionals that is not included in paragraph (b)(1) of th is section, the value-based paym ent modifier adjustment will be equal to the amount determined under §414.1275(c)(2). (3) For a group of physicians comprised of be tween 10 and 99 eligible professionals that is not included in paragraph (b)(1 ) of this section, the value-ba sed payment modifier adjustment will be equal to the amount determined under §414.1275(c)(2), except that such adjustment will be 0.0 percent if the group of physicians is determined to be low quality/high cost, low quality/average cost, or av erage quality/high cost. (4) If all of the elig ible professionals in a group of phys icians subject to the value-based payment modifier participate as individuals in the PQRS using a qualified clinical data registry or any other reporting mechanism available to them, and CMS is unable to receive quality performance data for those eligible professiona ls under that reporting mechanism, the quality

### CMS-1600-FC 1363

composite score for such group will be classified as “average” under §414.1275(b)(1). (5) A group of physicians subject to the valu e-based payment modifier will receive a cost composite score that is classified as “average” under §414.1275(b)(2) if such group does

not have at least one cost m easure with at least 20 cases. 43. Section 414.1275 is amended by revising paragraphs (a) a nd (c) and (d) introductory

text to read as follows: § 414.1275 Value-based payment modifier quality-tiering scoring methodology. (a) The value-based payment modifier amount for a group of physicians subject to the value-based payment modifier is based upon a co mparison of the composite of quality of care measures and a composite of cost measures.

* * * * * (c)(1) The following value-based payment m odifier percentages apply to the CY 2015 payment adjustment period: CY 2015 Value-Based Payment Modifier Amo unts for the Quality-Tiering Approach

Quality/cost Low cost Average cost High cost High quality +2.0x* +1.0x* +0.0% Average quality +1.0x* +0.0% -0.5% Low quality +0.0% -0.5% -1.0% * Groups of physicians eligible for an addi tional +1.0x if (1) reporting Physician Quality Reporting System quality measures through the GP RO web-interface or CMS-qualified registry, and (2) average beneficiary risk score is in the top 25 percent of all beneficiary risk scores.

(2) The following value-based payment modi fier percentages a pply to the CY 2016 payment adjustment period: CY 2016 Value-Based Payment Modifier Amounts for the Quality-Tiering Approach Quality/cost Low cost Average cost High cost High quality +2.0x* +1.0x* +0.0% Average quality +1.0x* +0.0% -1.0% Low quality +0.0% -1.0% -2.0%

### CMS-1600-FC 1364

* Groups of physicians eligible for an additional +1.0x if reporting Physician Quality Reporting System quality measures and average beneficiary risk score is in the top 25 percent of all be neficiary risk scores.

(d) Groups of physicians subject to the valu e-based payment modifier that have an attributed beneficiary population with an average risk score in the top 25 percent of the risk

scores of beneficiaries nati onwide and for the CY 2015 paymen t adjustment period elect the quality-tiering approach or for the CY 2016 pa yment adjustment period are subject to the quality-tiering approach, receive a greater upward payment adjustment as follows:

* * * * *

PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT 44. The authority citation for part 423 continues to read as follows: Authority : Sections 1102, 1106, 1860D-1 throu gh 1860D-42, and 1871 of the Social Security Act (42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh). 45. Section 423.160 is amended by— A. Revising paragraphs (b)(1)(i) through (iii). B. Adding paragraphs (b)(1)(iv), (b)( 5)(i) through (iii), and (c)(1)(vi).

The revisions and additions read as follows: §423.160 Standards for electronic prescribing.

* * * * * (b) * * * (1) * * * (i) Prior to April 1, 2009, the standards specified in paragrap hs (b)(2)(i), (b)(3) and (4), (b)(5)(i), and (b)(6). (ii) On or after April 1, 2009, to February 7, 2014, the standards spec ified in paragraphs

### CMS-1600-FC 1365

(b)(2)(ii), (b)(3) and (4), (b)(5)(i) and (b)(6). (iii) From February 8, 2014, until February 28, 2015, the standards specified in paragraphs (b)(2)(ii), (b)(3) and (4), (b)(5)(ii), and (b)(6). (iv) From March 1, 2015, the standards specif ied in paragraphs (b)(2)(ii), (b)(3) and (b)(4), (b)(5)(iii), and (b)(6).

* * * * * (5)* * * (i) Formulary and benefits . Before The National Council for Prescription Drug Programs Formulary and Benefits Standard, Implementa tion Guide, Version 1, Release 0 (Version 1.0), October 2005 (incorporated by reference in paragraph (c)(1)(ii) of this section) for transmitting formulary and benefits information between prescribers and Medicare Part D sponsors. (ii) Formulary and benefits . On The National Council for Prescription Drug Programs Formulary and Benefits Standard, Implementa tion Guide, Version 1, Release 0 (Version 1.0), October 2005 (incorporated by refere nce in paragraph (c)(1)(ii) of this section), or The National Council for Prescription Drug Programs Formular y and Benefits Standard, Implementation Guide, Version 3, Release 0 (Version 3.0), Apr il 2012 (incorporated by reference in paragraph (c)(1)(vi) of this section) for transmitting formul ary and benefits information between prescribers and Medicare Part D sponsors. (iii) Formulary and benefits. The Nati onal Council for Prescription Drug Programs Formulary and Benefits Standard, Implementa tion Guide, Version 3, Release 0 (Version 3.0), April 2012 (incorporation by reference in paragraph (c)(1)(vi) of this section) for transmitting formulary and benefits information between prescribers and Medicare Part D sponsors.

* * * * *

### CMS-1600-FC 1366

(c) * * * (1) * * * (vi) The National Council for Prescripti on Drug Programs Formulary and Benefits Standard, Implementation Guide, Version 3, Release 0 (Version 3.0), published April 2012.

* * * * *

PART 425—MEDICARE SHARED SAVINGS PROGRAM 46. The authority citation for part 425 continues to read as follows: Authority : Secs. 1102, 1106, 1871, and 1899 of the Social Security Act (42 U.S.C. 1302 and 1395hh). 47. Section 425.308 is amended by revising pa ragraph (e) to read as follows: §425.308 Public reporting and transparency.

* * * * * (e) Results of claims based measures . Quality measures reported using a CMS web interface and patient experience of care survey measures will be reported on Physician Compare in the same way as for the group practices th at report under the Physician Quality Reporting System. 48. Section 425.502 is amended by revising pa ragraph (b)(2) to read as follows: §425.502 Calculating the ACO quality performance score.

* * * * * (b) * * * (2)(i) CMS will define the quality benchmarks using fee-for-service Medicare data. (ii) CMS will set benchmarks us ing flat percentages when the 60 th 

### percentile is equal to or greater than 80.00 percent.

### CMS-1600-FC 1367

(iii) CMS reserves the right to use flat percentages for other measures when CMS

determines that fee-for-service Medicare data are unavailable, inadequate, or unreliable to set the quality benchmarks.

* * * * * 49. Section 425.504 is amended by: A. Revising the section heading. B. Revising paragraphs (a )(1), (b) headi ng, and (b)(1). C. Adding paragraphs (c) and (d).

The revisions and additions read as follows: §425.504 Incorporating reporting requirements rel ated to the Physician Quality Reporting System Incentive and Payment Adjustment. (a) * * * (1) ACOs, on behalf of their ACO provider/suppl iers who are eligible professionals, must submit the measures determined under §425.500 usi ng a CMS web interface, to qualify on behalf of their eligible professionals for the Physic ian Quality Reporting System incentive under the Shared Savings Program.

* * * * * (b) Physician Quality Reporting System payment adjustment for 2015 . (1) ACOs, on behalf of their ACO providers/s uppliers who are eligible profe ssionals, must submit one of the ACO GPRO measures determined under §425.500 us ing a CMS web interface, to satisfactorily report on behalf of their elig ible professionals for purposes of the 2015 Physician Quality Reporting System payment adjustment under the Shared Savings Program.

* * * * *

### CMS-1600-FC 1368

(c) Physician Quality Reporting System payment adjustment for 2016 and subsequent

years . (1) ACOs, on behalf of their ACO provide rs/suppliers who are eligible professionals, must submit all of the ACO GPRO measures determined under §425.500 using a CMS web interface, to satisfactorily report on behalf of their eligible pr ofessionals for purposes of the Physician Quality Reporting System payment adju stment under the Shared Savings Program for 2016 and subsequent years. (2) ACO providers/suppliers th at are eligible professiona ls within an ACO may only participate under their ACO participant TIN as a group practice under the Physician Quality Reporting System Group Practice Reporting Option of the Shared Savings Program for purposes of the Physician Quality Reporting System pa yment adjustment under the Shared Savings Program for 2016 and subsequent years. (3) If an ACO, on behalf of its ACO provide rs/suppliers who are e ligible professionals, does not satisfactorily report for purposes of th e Physician Quality Reporting System payment adjustment for 2016 and subsequent years, each ACO provider/supplier who is an eligible professional, will receive a payment adjustment, as described in § 414.90(e) of this chapter. (4) For eligible professionals subject to the Physician Qu ality Reporting System payment adjustment under the Medicare Shared Savings Program for 2016 and subsequent years, the Medicare Part B Physician Fee Schedule amount for covered professional services furnished during the program year is equal to the applicab le percent of the Medicare Part B Physician Fee

Schedule amount that would otherw ise apply to such services unde r section 1848 of the Act, as described in § 414.90(e) of this chapter. (d) The reporting period for a year is the ca lendar year from January 1 through December 31 that occurs 2 years prior to the program year in which the payment adjustment is applied.

### CMS-1600-FC

(Catalog of Federal Domestic Assistance Prog ram No. 93.773, Medicare--Hospital Insurance; and Program No. 93.774, Medicare--Supplemen tary Medical Insurance Program)

Dated: November 14, 2013

.

_______________________________ Marilyn Tavenner,

Administrator , Centers for Medicare & Medicaid Services

.

Approved: November 21, 2013

.

__________________________________ Kathleen Sebelius, Secretary , Department of Health and Human Services

.

BILLING CODE 4120-01-P

[FR Doc. 2013-28696 Filed 11/27/2013 at 4:15 pm; Publication Date: 12/10/2013]